Status:
COMPLETED
Preoperative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer
Lead Sponsor:
Sanofi
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00263029
Start Date
June 1 2002
Last Update
September 18 2009
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