Study 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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Rectal Neoplasms

Intervention / Treatment
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* Drug: Oxaliplatin, capecitabine
* Drug: Oxaliplatin, capecitabine


Participation Criteria
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Eligibility Criteria
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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 ≤ 2. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Oxaliplatin, capecitabine<br>* OXA 130 D1 + Capecitabine 2000 / day D1-D14 for 4 cycles. After 10 weeks of rest, XELOX-RT regimen x 5 weeks followed by surgery<br>* Other names: Radiotherapy;|
| Experimental: B<br> | Drug: Oxaliplatin, capecitabine<br>* XELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A.<br>* Other names: Radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | from the signature of Informed Consent up to the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative dose intensity |  | from the signature of Informed Consent up to end of the study | 
| 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 |