Clinical Trials Register

Summary
EudraCT Number:	2019-002074-32
Sponsor's Protocol Code Number:	IFOM-CPT005/2019/PO004
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-11-11
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2019-002074-32

A.3

Full title of the trial

POST-SURGICAL LIQUID BIOPSY-GUIDED TREATMENT OF STAGE III AND HIGH-RISK STAGE II COLON CANCER PATIENTS

TRATAMIENTO POSTQUIRÚRGICO GUIADO POR BIOPSIA LÍQUIDA DE PACIENTES CON CÁNCER DE COLON EN ESTADIO III Y ESTADIO II DE ALTO RIESGO

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

POST-SURGICAL LIQUID BIOPSY-GUIDED TREATMENT OF COLON CANCER PATIENTS

TRATAMIENTO POSTQUIRÚRGICO GUIADO POR BIOPSIA LÍQUIDA DE PACIENTES CON CÁNCER DE COLON

A.3.2

Name or abbreviated title of the trial where available

PEGASUS trial

Ensayo PEGASUS

A.4.1

Sponsor's protocol code number

IFOM-CPT005/2019/PO004

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	IFOM - Istituto FIRC di Oncologia Molecolare
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AIRC
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IFOM - Istituto FIRC di Oncologia Molecolare
B.5.2	Functional name of contact point	Precision Oncology Unit
B.5.3	Address:
B.5.3.1	Street Address	Via Adamello 16
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20139
B.5.3.4	Country	Italy
B.5.4	Telephone number	+3902574303862
B.5.6	E-mail	silvia.marsoni@ifom.eu

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	capecitabine
D.3.2	Product code	capecitabine
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CAPECITIABINE
D.3.9.1	CAS number	154361-50-9
D.3.9.2	Current sponsor code	CAPECITIABINE
D.3.9.3	Other descriptive name	CAPECITABINE
D.3.9.4	EV Substance Code	SUB12474MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	150 to 500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	oxaliplatinum
D.3.2	Product code	oxaliplatinum
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	OXALIPLATIN
D.3.9.1	CAS number	63121-00-6
D.3.9.2	Current sponsor code	OXA
D.3.9.4	EV Substance Code	SUB09490MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	50 to 250
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	5-FU
D.3.2	Product code	5-FU
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent) Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FLUOROURACIL
D.3.9.1	CAS number	51-21-8
D.3.9.2	Current sponsor code	5-FU
D.3.9.3	Other descriptive name	FLUOROURACIL
D.3.9.4	EV Substance Code	SUB07721MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	50 to 1000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Irinotecan
D.3.2	Product code	IRI
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IRINOTECAN HYDROCHLORIDE TRIHYDRATE
D.3.9.1	CAS number	136572-09-3
D.3.9.2	Current sponsor code	Irinotecan
D.3.9.3	Other descriptive name	IRINOTECAN HYDROCHLORIDE TRIHYDRATE
D.3.9.4	EV Substance Code	SUB45873
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	40 to 300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.2	Name of the Marketing Authorisation holder	67128
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Leucovorin
D.3.2	Product code	Leucovorin
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEUCOVORIN
D.3.9.2	Current sponsor code	LV
D.3.9.3	Other descriptive name	CALCIUM FOLINATE
D.3.9.4	EV Substance Code	SUB06052MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Stage III and high-risk stage II colon cancer

Cáncer de color en estadio III y estadio II de alto riesgo

E.1.1.1

Medical condition in easily understood language

Colon cancer

Cáncer de colon

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10061451
E.1.2	Term	Colorectal cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to study the feasibility of using liquid biopsy to guide the
post-surgical and post-adjuvant clinical management of stage III and high-risk stage
II (T4N0) MSS colon cancer patients.
Feasibility is defined as the ability of at least two subsequent negative ctDNA
determination to identify patients that will be NED (without radiologic evidence of
metastasis) 2 years aftersurgery

El objetivo primario es estudiar la factibilidad del uso de biopsias líquidas para guiar el manejo clínico post-quirúrgico y post-adyuvante de pacientes con cáncer de colon en estadío III y estadío II de alto riesgo (T4N0).
Factibilidad se define como la capacidad de utilizar el resultado negativo de de ctDNA en al menos 2 biopsias líquidas para identificar pacientes que estarán NED, es decir, libres de evidencia radiológica de metástasis, 2 años después de la cirugía.

E.2.2

Secondary objectives of the trial

- To compare the DFS and OS rates at 2,3 and 5 years in a cohort of 140 stage III and
high-risk stage II (only T4N0) MSS colon cancer patients treated post-surgically with
a LB guided strategy, with the DFS and OS rates of a 1:3 phenotypically matched cohort
of the TOSCA trial treated with FOLFOX/CAPOX either at 3 or 6 months.
• To compare the safety profile in a cohort of 140 stage III and high-risk stage II
(only T4N0) MSS colon cancer patients treated with a liquid biopsy-guided strategy,
with the safety profile of 1:3 phenotypically matched cohort of the TOSCA trial
treated with FOLFOX/CAPOX at 3 or 6 months. • To validate LB seroconversion as a proxy of therapy efficacy and to compare its
performance with CEA testing
whenever CEA levels are above the normal values.
• To study the QoL of patients in a cohort of 140 stage III and high-risk stage II
(only T4N0) MSS colon cancer patients treated post-surgically with a liquid biopsyguided
strategy

- Comparar la ratio de Supervivencia Libre de Enfermedad (SLE) y Supervivencia Global (SG) a los 2, 3 y 5 años en 140 pacientes con cáncer de colon con estabilidad microsatelitar (CCEM) y estadío III o II de alto riesgo (T4N0), con la SLE y SG en una cohorte en proporción 1:3, emparejada por fenotipo y tratada con FOLFOX/CAPOX por 3 o 6 meses en el estudio TOSCA
- Comparar el perfil de seguridad en 140 pacientes con CCEM y estadío III o II de alto riesgo (T4N0), tratados post-cirugía con una estrategia guiada por biopsias líquidas, con el perfil de seguridad de una cohorte 1:3, emparejada por fenotipo y tratada con FOLFOX/CAPOX por 3 o 6 meses en el estudio TOSCA
- Validar la negativización de la detección de ctDNA tras la administración de tratamiento como indicador de eficacia terapéutica y comparar su evolución con los valores de CEA en sangre en pacientes con niveles de CEA elevados

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Pegasus trial written informed consent.
2. Age = 18 years.
3. Histologically confirmed diagnosis of operable stage III or T4N0 stage II colon
cancer located 12 cm from the anal verge by endoscopy and above the peritoneal
reflection at surgery.
4. Availability of plasma collected prior to surgery.
5. Availability of the original FFPE tumor tissue.
6. Acceptance to undergo at least all the interventional liquid biopsies.
7. ECOG performance status 0-1.
8. Normal organ functions. (as defined in section 9.3)
9. Women with childbearing potential should complete a pregnancy test and be willing to
use highly effective contraceptive

1. Consentimiento informado escrito para el estudio PEGASUS
2. Edad ≥ 18 años
3. Diagnóstico histológicamente confirmado de cáncer de colon operable en estadío III o estadío II T4N0 localizado a 12 cm o más del margen anal por endoscopía y por encima del pliegue peritoneal en la cirugía.
4. Disponibilidad de plasma recogido antes de la cirugía.
5. Disponibilidad de los bloques tumorales FFPE.
6. Consentir a por lo menos todas las biopsias líquidas intervencionales
7. Performance status (ECOG) 0,1.
8. Función normal de los órganos (como definidos en la sección 9.3).
9. Las pacientes mujeres con potencial de gravidanza deben completar un test de embarazo y aceptar el uso de métodos contraceptivos de alta efectividad.

E.4

Principal exclusion criteria

1. Patients having a MSI-H/MMRd tumor are excluded from the study (done according to
standard clinical practice).
2. History of another neoplastic disease, unless in remission for = 5 years.
Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin,
or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have
undergone potentially curative therapy are not excluded.
3. Had an incomplete diagnostic colonoscopy and/or polyps removal.
4. Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients
should never have had any evidence of metastatic disease (including presence of tumor
cells in the peritoneal lavage).
5. Current or recent treatment with another investigational drug or participation in
another investigational study
6. Patient unable to comply with the study protocol owing to psychological, social or
geographical reasons.
7. Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the study.
8. Inadequate contraception (male or female patients) if of childbearing or
procreational potential.
9. Clinically relevant cardiovascular disease.
10. Acute or subacute intestinal occlusion or history of inflammatory bowel disease.
11. Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of
the components of the treatment.
12. Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant.
13. Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency.
14. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is
required.
15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
reactive)or known active Hepatitis C virus infection. Note: no testing for Hepatitis B
and Hepatitis C isrequired unless mandated by local health authority.
16. Has a known history of active TB (Bacillus

1. Pacientes con tumores que expresan MSI-H/MMRd (diagnostico efectuado con tests clínicos estándar) son excluídas del estudio.
2. Historia de otra enfermedad neoplásica a menos que esté en remisión por ≥ 5 años. Los pacientes con carcinoma basocelular de la piel, carcinoma escamoso de la piel o carcinomas in situ (por ejemplo cáncer de seno o carcinoma in situ del cuello uterino) que han recibido tratamiento potencialmente curativo no están excluídos.
3. Pacientes que tuvieron una colonoscopía diagnóstica incompleta y/o remoción de pólipos incompleta.
4. Evidencia macroscópica o microscópica de tumor residual (resecciones tipo R1 o R2). Los pacientes no deben haber tenido nunca evidencia de enfermedad metastática (que incluye presencia de células tumorales en el lavado peritoneal).
5. Tratamiento actual o reciente con otra medicina investigacional o participación en otro estudio investigacional.
6. Paciente incapaz de cumplir con los requerimientos del protocolo del estudio por motivos psicológicos, sociales o geográficos.
7. Pacientes embarazadas o dando pecho, o que desean concebir o engendrar hijos durante el período proyectado de duración del estudio.
8. Uso de métodos contraceptivos inadecuados (tanto los pacientes hombres como mujeres) si en edad con potencial de procrear.
Enfermedad cardiovascular clínicamente relevante.
9. Enfermedad cardiovascular clínicamente relevante
10. Oclusión intestinal aguda o subaguda o historia de enfermedad inflamatoria intestinal.
11. Historia de neuropatía > grado 1. Historia de reacciones alérgicas grado 3 o 4 a la administración de cualquiera de los components del tratamiento.
12. Pacientes con sindromes de Gilbert o variante germinal homozigótica UGT1A1 *28/*28
13. Historia conocida de deficiencia de DPD (DihydroPyrimidine Dehydrogenase).
14. Historia de infección con Virus de la Inmunodeficiencia Humana (VIH). Nota: que no se requiere efectuar el test de VIH.
15. Historia previa de Hepatitis B (definida como presencia de antigen de superficie de la hepatitis B [Hbs Ag] o que se sabe que presenta infección activa con el virus de la Hepatitis B. Nota: no se requiere realizar test de Hepatitis B ni de Hepatitis C a menos que sea un requerimiento de las autoridades locales.
16. Historia conocida de infección tuberculosa activa (Bacilo de la Tuberculosis, TB).

E.5 End points

E.5.1

Primary end point(s)

Number of post-surgery and post-adjuvant false negative cases after a double ctDNAnegative
detection, defined as cases that become positive at subsequent interventional
LB or that experience radiological relapse within 2 years.

Número de falsos negativos post-cirugía y post tratamiento adyuvante luego de una doble detección con resultados negativos para ctDNA, definido como casos que se hacen positivos en una siguiente BL intervencional o que experimentan recurrencia radiológica dentro de 2 años.

E.5.1.1

Timepoint(s) of evaluation of this end point

within 2 years from surgery

en los 2 años que siguen a la cirugía

E.5.2

Secondary end point(s)

1- Disease-Free Survival (DFS) at 2 and 3-years, Overall Survival (OS) at 5-years.
2- Safety and tolerability avvording to CTCAE version 4.03
3- Number of patients experiencing ctDNA seroconversion (i.e. ctDNA+ that become ctDNA-)
after any chemotherapy regimen remaining disease free at 2 and 3 years.
4- Assessment of QLQ-C30 and CR-29 EORTC questionnaires

1- Supervivencia libre de enfermedad a 2 y 3 años, Supervivencia Global a 5 años.
2- Seguridad y tolerabilidad de acuerdo con CTCAE versión 5.0.
3- Número de pacientes que muestran un seroconversión de ctDNA (es decir, que siendo ctDNA+ se transforman en ctDNA-) luego de cualquiera de los regímenes de quimioterapia y permanecen libres de enfermedad a 2 y 3 años.
4- Evaluación de los cuestionarios QLQ-C30 y EORTC CR-29.

E.5.2.1

Timepoint(s) of evaluation of this end point

1- 2, 3 and 5 years
2- the whole study
3- at 2 and 3 years
4- the whole study

1- 2, 3 y 5 años
2- durante todo el estudio
3- a los 2 y 3 años
4- durante todo el estudio

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Feasibility of using liquid biopsy to guide post-surgical and post-adjuvant
clinical management of patients with colon cancer

Factibilidad de usar la biopsia líquida para guiar el manejo clínico post-quirúrgico y post-adyuvante de pacientes con cáncer de colon.

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

cohorte histórica del ensayo clínico TOSCA

historical cohort of the TOSCA clinical trial

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

LVLS (última visita del último paciente)

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

140

F.4.2.2

In the whole clinical trial

140

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

clinical standard therapies

tratamiento clínico estándar

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-02-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-01-16

P. End of Trial
P.	End of Trial Status	Ongoing

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