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    Summary
    EudraCT Number:2014-003392-32
    Sponsor's Protocol Code Number:SPON1610-17
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-08-27
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-003392-32
    A.3Full title of the trial
    A Phase III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV)- positive oropharyngeal cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate reduced intensity post-operative treatment for HPV positive throat cancer
    A.3.2Name or abbreviated title of the trial where available
    Post-operative adjuvant treatment for HPV-positive tumours (PATHOS)
    A.4.1Sponsor's protocol code numberSPON1610-17
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02215265
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCardiff University
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCancer Research UK (CRUK)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEORTC
    B.5.2Functional name of contact pointregulatory affairs department
    B.5.3 Address:
    B.5.3.1Street AddressAv. E. Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3227741366
    B.5.5Fax number+3227727063
    B.5.6E-mailregulatory@eortc.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCisplatin
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCISPLATIN
    D.3.9.1CAS number 15663-27-1
    D.3.9.3Other descriptive namecis diamminedi- chloroplatinum (II)
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecarboplatin
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcarboplatin
    D.3.9.1CAS number 41575-94-4
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    oropharyngeal squamous cell carcinoma
    E.1.1.1Medical condition in easily understood language
    Throat cancer
    cáncer orofaríngeo
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10031117
    E.1.2Term Oropharyngeal squamous cell carcinoma stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10079785
    E.1.2Term Oropharyngeal squamous cell carcinoma stage IV
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To demonstrate if swallowing function can be improved and toxicities reduced following transoral surgery for HPV-positive oropharyngeal cancer, by reducing the intensity of adjuvant treatment protocols.
    2. To demonstrate the non-inferiority of reducing the intensity of adjuvant treatment protocols in terms of overall survival
    1. Demostrar si se puede mejorar la función de deglución y reducir las toxicidades después de la cirugía transoral para el cáncer orofaríngeo VPH + al reducir la intensidad de los protocolos de tratamiento complementario.
    2. Demostrar la no inferioridad de la reducción de la intensidad de los protocolos de tratamiento complementario en términos de supervivencia general
    E.2.2Secondary objectives of the trial
    1. Standardisation of transoral surgery for OPSCC by rigorous application of surgical standards.
    2. The credentialing of participating surgeons.
    3. Standardisation of surgical margin assessment after transoral surgery and examination of the clinical-pathological correlates of HPV-positive OPSCC by central pathology review of specimens.
    4. Development of a standardised, multi-faceted swallowing assessment tool for patients undergoing treatment for OPSCC, applicable by Speech and Language Therapists (SLTs) in multiple centres.
    5. Development of a RTTQA package and adjuvant Intensity Modulated Radiotherapy (IMRT) protocol for OPSCC. Dose/volume data for swallowing structures will be recorded so that the relationship between long-term swallowing function (phase II endpoint) and dose/volumes received by the swallowing organs can be prospectively analysed.
    6. A programme of translational research will be developed to utilize PATHOS clinical samples.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PATHOS TRANS (PATHOS T)
    The PATHOS-T bioresources, together with data from the PATHOS clinical trial, will underpin a unique programme of translational research, PATHOS-Trans (see section 1.2 of the Protocol). As part of the PATHOS T sub-study, International sites will provide FFPE samples which will be requested at a later date and shipped to the GCP Lab in Liverpool.
    The main aims of PATHOS-Trans are:
    To use the tissue bioresource:
    1. To understand the fundamental biological differences, particularly with respect immunobiology, viral pathogenesis and intra-tumour heterogeneity, between HPV+ OPSCCs that respond to treatment and those that do not.
    2. To define genomic and gene expression molecular profiles as putative biomarkers that will robustly discriminate non-responders and responders, informing safe treatment deintensification for responders whilst identifying patients for whom novel intensified
    treatment strategies are required.
    3. In keeping with Aim 2, to define biological targets against which novel therapeutic strategies can be directed to enhance non-responder outcomes.
    PATHOS-T:
    Solo para los pacientes del Reino Unido: La recogida de muestras traslacionales se llevará a cabo en los siguientes puntos temporales: antes de la cirugía (sangre), durante la cirugía (biopsias de tejido recientes del tumor y los ganglios linfáticos) y después de la cirugía (bloque FFIP de tejido) y obtención de muestras de sangre en serie de seguimiento a las 4 semanas y aproximadamente 6, 12, 18 y 24 meses después de la finalización del tratamiento.
    Con sujeción a la financiación y el acuerdo local, los bloques de tejido tumoral fijado en formalina y embebido en parafina se recuperarán de los centros internacionales.
    E.3Principal inclusion criteria
    • Histologically confirmed or suspected squamous cell carcinoma of the oropharynx.
    • UICC/AJCC TNM 7th edition stage T1-T3, N0-N2b (or UICC TNM 8th edition stage T1-T3, N0-N1) disease. [Staging should be based on cross sectional imaging investigations carried out within 10 weeks of study entry].
    • Multidisciplinary team (MDT) decision to treat with primary transoral resection and neck dissection.
    • Patients considered fit for surgery and adjuvant radiotherapy
    • Aged 18 or over.
    • Written informed consent provided.
    • Carcinoma de células escamosas de orofaringe confirmado histológicamente o sospechado.
    • Enfermedad en estadificación según la 7a edición de TNM de la UICC/AJCC T1-T3, N0-N2b (o estadificación según la 8a edición de TNM de la UICC T1-T3, N0-N1). [La estadificación debe basarse en investigaciones de imágenes transversales realizadas en las 10 semanas posteriores a la entrada en el estudio].
    • Decisión de un equipo multidisciplinar (MDT) para tratar con resección transoral primaria y linfadenectomía cervical.
    • Pacientes considerados aptos para la cirugía y radioterapia complementaria.
    • Tener 18 años o más.
    • Otorgamiento de consentimiento informado por escrito.
    E.4Principal exclusion criteria
    • Known HPV negative squamous cell carcinomas of the head and neck: A negative result for p16 Immunohistochemistry automatically excludes a patient from the trial. If initial p16 testing is positive but High Risk HPV (HR HPV) In-Situ Hybridization (ISH) / Polymerase Chain Reaction (PCR) does not demonstrate the presence of HR HPV DNA, the patient will also be excluded. Patients who are p16 positive may complete swallowing assessments, excluding videofluoroscopy, and surgery whilst HR HPV DNA status is being determined (with recourse to central concordance testing, if appropriate, for UK centres). HPV positivity, as determined by p16 and the demonstration of HR HPV DNA is essential before patients undergo videofluoroscopy or randomisation.
    • T4 and/or T1-T3 tumours where transoral surgery is considered not feasible.
    • UICC/AJCC TNM 7th edition N2c-N3 nodal disease (or UICC/AJCC TNM 8th edition N2-N3 nodal disease).
    • Patients for whom transoral surgery and neck dissection is not considered the primary treatment modality.
    • Current smokers with N2b disease (including smokers up to 6 months before diagnosis), even if HPV-positive. Vaping is permitted and should be considered as non-smoking status.
    • Any pre-existing medical condition likely to impair swallowing function and/ or a history of pre-existing swallowing dysfunction prior to index oropharyngeal cancer.
    • Patients with distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g., CT thorax and upper abdomen or PET-CT.
    • Patients with a history of malignancy in the last 5 years, except basal cell carcinoma of the skin or carcinoma in-situ of the cervix.
    • Women who are pregnant or breastfeeding and fertile women who will not be using contraception during the trial.
    • Carcinomas de células escamosas negativos para el VPH de cabeza y cuello conocidos: [Un resultado negativo para la inmunohistoquímica p16 excluirá automáticamente al paciente del ensayo. Si la prueba inicial de p16 es positiva pero la hibridación in situ de VPH de alto riesgo (VPH de AR)/reacción en cadena de la polimerasa (PCR) no demuestra la presencia de ADN del VPH de AR, también se excluirá al paciente. Los pacientes positivos para p16 pueden completar las evaluaciones de la deglución, exceptuando la videofluoroscopia, y la cirugía mientras se esté determinando el estado de ADN del VPH de AR (con posibilidad de recurrir a las pruebas de concordancia central, si procede, para los centros del Reino Unido). Es crucial que se confirme el resultado positivo para el VPH, determinado por p16 y la demostración de ADN del VPH de AR, antes de que los pacientes se sometan a una videofluoroscopia o a la aleatorización].
    • Tumores T4 y/o T1-T3 en los que la cirugía transoral no se considera viable.
    • Enfermedad ganglionar N2c-N3 de 7a edición de TNM de la UICC/AJCC (o enfermedad ganglionar N2-N3 de 8a edición de TNM de la UICC/AJCC).
    • Pacientes para quienes la cirugía transoral y la linfadenectomía cervical no se consideran la modalidad de tratamiento principal.
    • Fumadores actuales con enfermedad con N2b (incluidos los pacientes que fumaran hasta 6 meses antes del diagnóstico), incluso si son positivos para el VPH. Se permiten los cigarrillos electrónicos, y sus consumidores serán considerados no fumadores.
    • Cualquier afección médica preexistente que pueda afectar a la función de deglución y/o antecedentes de disfunción de deglución preexistente antes del cáncer orofaríngeo índice.
    • Enfermedad metastásica a distancia determinada mediante las exploraciones radiológicas de estadificación preoperatoria rutinarias, p. ej., TAC o TEP torácica y de la parte superior del abdomen.
    • Antecedentes de neoplasia maligna en los últimos 5 años, excepto carcinoma basocelular de la piel o carcinoma in situ del cuello uterino.
    • Mujeres embarazadas o en periodo de lactancia y mujeres fértiles que no vayan a utilizar anticonceptivos durante el ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival and swallowing function as measured by the MD Anderson Dysphagia Inventory (MDADI) score. OS at 3 years
    • La función de supervivencia general y deglución medida por la Puntuación del MD Anderson Dysphagia Inventory (MDADI) (Apéndice 6).
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 12 months
    Evaluaciones en los 12 meses
    E.5.2Secondary end point(s)
    • Swallowing panel including qualitative and quantitative swallowing assessments (100ml Water Swallow Test, Performance Status Scale-Head & Neck)
    • QOL (using validated EORTC QLQ C30 and HN35 questionnaires, Appendix 7)
    • Acute and late toxicity using CTACE version 4.03 (Appendix 8)
    • Overall survival, disease free survival, locoregional control, distant metastases.
    • Mediciones del panel de deglución, incluidas las evaluaciones cualitativas y cuantitativas, como se ha descrito anteriormente.
    • CdV (usando los cuestionarios EORTC QLQ C30 y HN35, Apéndice 7).
    • Toxicidad aguda y tardía, evaluada según los criterios NCI CTCAE, versión 4.03 (Apéndice 8).
    • Supervivencia general, supervivencia sin enfermedad, control locorregional, metástasis a distancia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessments take place at baseline (before surgery), 4 weeks post surgery and then at 1, 6, 12, 24 months and 5 years after adjuvant therapy
    baseline, 4 semanas (+/- 2 semanas) posteriores al tratamiento, 6, 12, 24 meses posteriores al tratamiento y 5 años después del tratamiento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Radiotherapy
    Biobanking
    Quality of Life (QoL)
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    radiotherapy
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    United States
    France
    Germany
    Netherlands
    Spain
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of the trial is defined as the date of final data capture to meet the trial endpoints.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years11
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 726
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 374
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 261
    F.4.2.2In the whole clinical trial 1100
    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 follow-up after treatment (for disease recurrence/death) should be carried out as per routine practice for at least 5 years in accordance with National guidelines. Specifically, patients should undergo regular full examination of the head and neck according to the following schedule: year 1- every 4-8 weeks; year 2-every 8-12 weeks; year 3- every 3-5 months; years 4 and 5 – approximately every 6 months.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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