NCT00421824
Completed
Phase 2
Phase II Randomized Trial of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Oxaliplatin, capecitabine
- Conditions
- Rectal Neoplasms
- Sponsor
- Sanofi
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Response rate
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
Primary:
- To assess complete pathological response rate of both strategies.
Secondary:
- Safety profile
- To assess downstaging rate of both strategies.
- To compare relative dose intensity of oxaliplatin and capecitabine of both strategies
- To compare time to progression and overall survival of both strategies.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with rectal adenocarcinoma.
- •Operable tumour, confirmed by magnetic resonance of high resolution and / or endorectal echography, or,
- •Rectal tumour at distal third, or
- •Tumours spread more than 5 mm in perirectal fat
- •Functional state ECOG ≤
- •Good hematological, hepatic and renal function
Exclusion Criteria
- •Previous pelvis radiotherapy.
- •Previous antitumoural chemotherapy
- •Pregnant or breastfeeding women.
- •Childbearing women with a positive pregnancy test result at baseline. Menopausal women should not have the period for the last 12 months.
- •History of any other neoplastic illness within the last 5 years, except for already resolved small cell skin cancer or cervix cancer.
- •Clinically significant cardiovascular disease
- •Confirmed peripheral neuropathy.
- •Gastrointestinal disorders or bad absorption syndrome or non-capable to take oral medication.
- •Blood disorders.
- •Intercurrent non-controlled or severe infections.
Arms & Interventions
A
Intervention: Oxaliplatin, capecitabine
B
Intervention: Oxaliplatin, capecitabine
Outcomes
Primary Outcomes
Response rate
Time Frame: from the signature of Informed Consent up to the end of the study
Secondary Outcomes
- Disease free survival(from the signature of Informed Consent up to end of the study)
- Overall survival(from the signature of Informed Consent up to end of the study)
- Relative dose intensity(from the signature of Informed Consent up to end of the study)
Study Sites (1)
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