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

NCT00263029 | Completed Phase 2

• 1 other identifier: L_8479
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events collection

  From the signature of the informed consent up to the end of the study

Study Arms (1)

1

EXPERIMENTAL

Drug: Oxaliplatin; Drug: Capecitabine; Radiation: Radiotherapy

Interventions

Oxaliplatin DRUG

60mg/m² as a 2-hour intravenous infusion every week for 5-6 week

1

Capecitabine DRUG

500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart

1

Radiotherapy RADIATION

Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Oxaliplatin; Capecitabine; Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Therapeutics

Study Officials

• Iris CHAN, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 7, 2005
• Study Start: June 1, 2002
• Primary Completion: March 1, 2007
• Last Updated: September 18, 2009

Record last verified: 2008-09