Preoperative Panitumumab and Radiotherapy in Rectal Cancer

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the activity of panitumumab in combination with standard preoperative radiotherapy in locally advanced rectal cancer, followed by complete surgery and adjuvant chemotherapy.

The main hypothesis of the study is that the association of EGFR-targeting agent and radiation therapy could be as effective or even improve the rate of pathological complete tumoral response with fewer toxicities in comparison to the standard of care using chemoradiation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Treatments: Antibodies, Monoclonal; Panitumumab

Criteria

Inclusion Criteria:

• ECOG Performance Status 0-1

• Histologically proven adenocarcinoma of the rectum, T3-T4 and/or N+ M0

• Wild-type KRAS

• No prior pelvic irradiation

• Normal bone marrow, hepatic, renal, cardiac functions

• No secondary malignancy

• No other active, uncontrolled disease

• Signed informed consent

Exclusion Criteria:

• KRAS mutation

• Established or suspected metastasis

• Prior pelvic irradiation

• Previous exposure to EGFR-targeting therapies

• Patients under any other investigational agent(s)

• Concurrent systemic immune therapy, chemotherapy, hormone therapy

• Drug and/or alcohol abuse

• Grade 3 to 4 allergic reaction to any of the components of the treatment

• History or presence of interstitial lung disease

• Active, uncontrolled cardiovascular disease