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

Rectal Neoplasms Clinical Trial

— PROCTFUL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263029
• Other study ID #: L_8479
• Status: Completed
• Phase: Phase 2
• First received: December 6, 2005
• Last updated: September 17, 2009
• Start date: June 2002

Study information

• Verified date: September 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Drug:
• Oxaliplatin
60mg/m² as a 2-hour intravenous infusion every week for 5-6 week
• Capecitabine
500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse events collection		From the signature of the informed consent up to the end of the study	No