E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally advanced adenocarcinoma of the rectum (T3 - T4 and/or N+ M0), previously untreated and non metastatic disease |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038038 |
E.1.2 | Term | Rectal cancer |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the antitumor activity of panitumumab in combination with preoperative external beam radiotherapy in patients with locally advanced rectal cancer, followed by surgery and adjuvant chemotherapy.
The primary objective is the complete pathological response of the tumor. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety of the regimen as well as the impact on local control of the disease and the disease-free survival probability (in other words, safety and efficacy) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Minimum age of 18 years old. Performance status : ECOG 0 to 1. Histologically proven rectal adenocarcinoma. Wild-type K-Ras. T3-T4 or/and nodal involvement visualized by rectal ultrasound and/or MRI. No metastasis. No prior pelvic irradiation. Normal bone marrow, hepatic and renal function. Absence of active second malignancy during the last 5 years. Signed informed consent. Presence of effective contraception in fertile patients. Absence of any other uncontrolled severe pathology precluding administration of chemotherapy and radiotherapy. No other conditions (psychological, familial, sociological, geographical) which could interfere with the compliance to the study protocol and follow-up. |
|
E.4 | Principal exclusion criteria |
Metastasis (established or suspected). K-Ras mutation. Previous exposure to EGF and/or EGFR-targeting therapies. Concurrent immune therapy, chemotherapy, hormone therapy, or any other investigational agents within 4 weeks prior to enrollment. Prior pelvic irradiation. Grade 3-4 allergic reaction to any components of the treatment. Severe and uncontrolled cardiovascular disease. History of interstitial lung disease confirmed by radiology. Drug and/or alcohol abuse. Absence of reliable informed consent.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Pathological complete response of the tumor (ypT0N0) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
|
The trial ends at the last follow-up visit of the last subject undergoing the trial. The last follow-up visit is fixed at 24 months after the day of the surgery. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |