NCT00421824CompletedPhase 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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Response rate
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Patients who have undergone major surgery, open biopsies or with significant trauma lesions within the previous 28 days.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Arms & Interventions
A
Experimental
Intervention: Oxaliplatin, capecitabine (Drug)
B
Experimental
Intervention: Oxaliplatin, capecitabine (Drug)
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)
Investigators
Study Sites (1)
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