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

NCT ID: NCT00263029

Last Updated: 2009-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30

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.

Conditions

Rectal Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

60mg/m² as a 2-hour intravenous infusion every week for 5-6 week

Capecitabine

Intervention Type: DRUG

500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart

Radiotherapy

Intervention Type: RADIATION

Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions

Interventions

Oxaliplatin

60mg/m² as a 2-hour intravenous infusion every week for 5-6 week

Intervention Type: DRUG

Capecitabine

500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart

Intervention Type: DRUG

Radiotherapy

Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Iris CHAN, MD

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

L_8479

Identifier Type: -

Identifier Source: org_study_id