Rectal Neoplasms
Conditions
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 rectum.
Interventions
DRUGOxaliplatin
60mg/m² as a 2-hour intravenous infusion every week for 5-6 week
DRUGCapecitabine
500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart
RADIATIONRadiotherapy
Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Adverse events collection | From the signature of the informed consent up to the end of the study |
Outcome results
None listed