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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011325-14-BE

Enrollment

Registered

2009-05-25

Start date

2009-08-11

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Vectibix 20 mg/ml concentrate for solution for infusion Product Name: panitumumab Product Code: AMG954 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Panit

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. 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)	—

Measure

Time frame

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. 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)

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026