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

Study Overview
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Brief Summary
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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.

Official Title
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Pre-operative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer (PROCTFUL)

Conditions
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Rectal Neoplasms

Intervention / Treatment
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* Drug: Oxaliplatin
* Drug: Capecitabine
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Oxaliplatin<br>* 60mg/m² as a 2-hour intravenous infusion every week for 5-6 week<br>Drug: Capecitabine<br>* 500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart<br>Radiation: Radiotherapy<br>* Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (both clinical and pathological) of the primary rectal cancer observed after the chemoradiotherapy. Histologically confirmed complete resection rate (R0 rate). |  | 3-years disease- free-survival or 3-years overall survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events collection |  | From the signature of the informed consent up to the end of the study |