Phase II Study of Preoperative Panitumumab and External Beam Radiotherapy in Patients with Locally Advanced Rectal Cancer

Phase 1

• Conditions: ocally advanced adenocarcinoma of the rectum (T3 - T4 and/or N+ M0), previously untreated and non metastatic disease; MedDRA version: 9.1Level: LLTClassification code 10038038Term: Rectal cancer

• Registration Number: EUCTR2009-011325-14-BE
• Lead Sponsor: Cliniques Universitaires Saint-Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-25
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. <br><br>The primary objective is the complete pathological response of the tumor.;Secondary Objective: 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);Primary end point(s): Pathological complete response of the tumor (ypT0N0)