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

Sanofi0 sites18 target enrollmentJune 2002

ConditionsRectal Neoplasms

InterventionsOxaliplatin Capecitabine Radiotherapy

DrugsOxaliplatin Capecitabine

Overview

Phase: Phase 2
Intervention: Oxaliplatin
Conditions: Rectal Neoplasms
Sponsor: Sanofi
Enrollment: 18
Primary Endpoint: Response rate (both clinical and pathological) of the primary rectal cancer observed after the chemoradiotherapy. Histologically confirmed complete resection rate (R0 rate).
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2002

End Date

March 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

•ECOG performance status score 0-
•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.

Arms & Interventions

1

Intervention: Oxaliplatin

1

Intervention: Capecitabine

1

Intervention: Radiotherapy

Outcomes

Primary Outcomes

Response rate (both clinical and pathological) of the primary rectal cancer observed after the chemoradiotherapy. Histologically confirmed complete resection rate (R0 rate).

Time Frame: 3-years disease- free-survival or 3-years overall survival