Preoperative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer

Phase 2

Completed

• Conditions: Rectal Neoplasms
• Interventions: Drug: Oxaliplatin; Drug: Capecitabine; Radiation: Radiotherapy

• Registration Number: NCT00263029
• Lead Sponsor: Sanofi

Brief Summary

The purpose of this phase II trial is to determine the efficacy and safety of the combination of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced cancers of the rectum.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2005-12-06
• Study First Submitted QC: 2005-12-06
• Study First Posted: 2005-12-07
• Primary Completion: 2007-03
• Status Verified: 2008-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• ECOG performance status score 0-1.

• Chemo-naïve patients.

• Histologically/cytologically confirmed diagnosis of rectal adenocarcinoma (clinically stage mT3 or mT4), either considered (1)inoperable, or (2)locally advanced, where histologically confirmed curative resection is considered unlikely.

• Evaluable measurable disease on imaging with MRI/CT to allow for response assessment.

• Adequate haematological, renal and liver functions as follows:

  • ANC > 3000ml
  • Platelet count > 100,000 ml
  • Urea & Serum Creatinine < 1.5 X upper limit of normal value
  • Total serum bilirubin < 1.5 X upper limit of normal value
  • ALT & AST < 3 X upper limit of normal value

Exclusion Criteria

• Prior chemotherapy.
• Documented allergy to oxaliplatin or capecitabine.
• Prior radiotherapy to pelvis.
• Previous or concurrent malignancies at other sites with the exception of basal or squamous cell carcinoma of the skin.
• Pregnant or lactating females (with negative pregnancy test documentation in pre-menopausal female patients).
• Currently participating into another clinical trial with any investigational drug in the previous 30 days.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Oxaliplatin	-
1	Radiotherapy	-
1	Capecitabine	-

Primary Outcome Measures

Name	Time	Method
Response rate (both clinical and pathological) of the primary rectal cancer observed after the chemoradiotherapy. Histologically confirmed complete resection rate (R0 rate).	3-years disease- free-survival or 3-years overall survival

Secondary Outcome Measures

Name	Time	Method
Adverse events collection	From the signature of the informed consent up to the end of the study