Clinical Trials Register

Summary
EudraCT Number:	2006-006532-21
Sponsor's Protocol Code Number:	40054-22062
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2008-04-23
Trial results	View 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

Belgium - FPS Health-DGM

A.2

EudraCT number

2006-006532-21

A.3

Full title of the trial

Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer (PETACC-6)

A.3.1

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

Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer (PETACC-6)

A.3.2

Name or abbreviated title of the trial where available

PETACC-6

A.4.1

Sponsor's protocol code number

40054-22062

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	EORTC
B.1.3.4	Country	Belgium
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	Roche
B.4.2	Country	Switzerland
B.4.1	Name of organisation providing support	Roche
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	EORTC GI Group
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	EORTC
B.5.2	Functional name of contact point	Project, Budget & Regulatory Dpt
B.5.3	Address:
B.5.3.1	Street Address	Avenue E. Mounier 83/11
B.5.3.2	Town/ city	Brussels
B.5.3.3	Post code	1200
B.5.3.4	Country	Belgium
B.5.4	Telephone number	N-A
B.5.5	Fax number	N-A
B.5.6	E-mail	regulatory@eortc.be

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.2.1.1.1	Trade name	Eloxatin
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Synthelabo Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	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	61825943
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	5
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	Comparator
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.2.1.1.1	Trade name	Xeloda
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	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	capecitabine
D.3.9.3	Other descriptive name	CAPECITABINE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	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.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

locally advanced rectal cancer

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10038050
E.1.2	Term	Rectal cancer stage III
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10038049
E.1.2	Term	Rectal cancer stage II
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

To investigate whether the addition of oxaliplatin to preoperative fluoropyrimidine-based chemoradiation and postoperative fluoropyrimidine-based chemotherapy improves disease-free survival in patients with locally advanced rectal cancer. Disease-free survival is defined as the interval from randomization to loco-regional failure, metastatic recurrence, the appearance of a secondary colorectal cancer or death, whichever occurs first.

E.2.2

Secondary objectives of the trial

secondary objectives are to compare the two treatment arms with respect to overall survival, loco-regional failure, distant failure, pathological down-staging (ypT0-2N0) rate, pathological complete remission (ypT0N0) rate, tumor regression grade, histopathological R0 resection rate, sphincter preservation rate, perioperative complication rate, toxicity (CTC).

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

PACE assessment in elderly patients

E.3

Principal inclusion criteria

Male or female patients with histologically proven adenocarcinoma of the rectum (tumour ≤ 12
cm from the anal verge as assessed by rigid proctoscopy).
¨ Clinical tumour stage T3/4 or any node-positive disease (clinical stage according the TNM
classification system (Appendix J), positive nodes as diagnosed on endorectal ultrasound and/or
MRI). Tumour is staged by preferably a high resolution MRI. If MRI is not available,
locoregional staging must be performed by computed tomography plus endorectal ultrasound.
¨ No evidence of metastatic disease (as evidenced by negative CT-scan of the chest and
abdomen).
¨ The disease must be considered either resectable at the time of entry or expected to become
resectable after preoperative chemoradiation.
¨ Age ≥ 18 years.
¨ WHO/ECOG Performance Status ≤ 2
¨ No prior cytotoxic chemotherapy or radiotherapy for rectal cancer.
¨ No prior radiotherapy to the pelvis, for any reason.
¨ Presence of adequate contraception in fertile patients. Adequate methods of contraception are:
intra-uterine device, hormonal contraception, condom use with spermicide. Pregnant or
breastfeeding women are excluded from participation.
¨ Adequate bone marrow, hepatic and renal function:
¨ Haemoglobin ≥ 10.0 g/dL (transfusions allowed to achieve or maintain levels), absolute
neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L,
¨ ALAT, ASAT ≤ 2.5 x ULN,
¨ Alkaline phosphatase ≤ 2.5 x ULN,
¨ Total bilirubin ≤ 1.5 x ULN,
¨ Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault) and
¨ Creatinine ≤ 1.5 x ULN.
¨ Ability to swallow tablets.
¨ Patient must not have been treated with any investigational drug, agent nor procedure, (i.e. did
not participate in another trial within 4 weeks) before entry in this trial.
No previous (within the last 5 years) or concurrent malignancies, with the exception of
adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell carcinoma of the
skin.
¨ No clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic
coronary artery disease and cardiac arrhythmia not well controlled with medication) or
myocardial infarction within the last 12 months.
¨ No known allergy or any other adverse reaction to any of the study drugs or to any related
compound.
¨ No known dihydropyrimidine dehydrogenase deficiency.
¨ No known significant impairment of intestinal resorption (e.g. chronic diarrhoea, inflammatory
bowel disease).
¨ No pre-existing condition which would deter chemoradiotherapy or radiotherapy, i.e. fistulas,
severe ulcerative colitis (particularly patients currently taking sulphasalazine), Crohn’s disease,
prior adhesions.
¨ No peripheral neuropathy ≥ grade 2 (according to CTCAE v3.0)
¨ No serious uncontrolled intercurrent infections or other serious uncontrolled concomitant
disease.
¨ No organ allograft requiring immunosuppressive therapy.
¨ No requirement for concurrent use of the antiviral agent sorivudine or chemically related
analogues, such as brivudine.
¨ No history of uncontrolled seizures, central nervous system disorders or psychiatric disability
judged by the investigator to be clinically significant precluding informed consent or interfering
with compliance for oral drug intake.
¨ No psychological, familial, sociological or geographical condition potentially hampering
compliance with the study protocol and follow-up schedule (these conditions should be
discussed with the patient before registration in the trial).
¨ Patients can only be randomized once in this trial.
¨ Written informed consent before randomization according to ICH-GCP, and local, national and
international regulations.

E.4

Principal exclusion criteria

-severe renal impairment (creatinine clearance below 30 ml/min)
-pregnancy and lactation
-hypersensitivity to capecitabine or 5-FU or to any of the excipients
-patients with history of severe and unexpected reactions to fluoro pyrimidine therapy
-patients with known dihydropyrimidine dehydrogenase (DPD) deficiency
-patients with severe leucopenia, neutropenia and thrombocytopenia
-severe hepatic impairment
-concomittant use of sorivudine or its chemically related analogues such as brivudine
-patients with known allergy against oxaliplatin or other platinum compounds
-patients with impaired bone marrow function
-patients with pre-excisting peripheral neuropathy

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is disease-free survival

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

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

proteomics

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Information not present in EudraCT

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

160

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial 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

as defined in the protocol (page 80)

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

E.8.9.2

In all countries concerned by the trial days

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.1.3

Elderly (>=65 years)

Yes

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-04-23.

Yes

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

250

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1060

F.4.2.2

In the whole clinical trial

1090

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)

normal treatment of the condition

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

2008-05-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-10-27

P. End of Trial
P.	End of Trial Status	Completed

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