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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Rectal Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

3-years disease- free-survival or 3-years overall survival

Safety Issue:

No

Principal Investigator

Iris CHAN, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Hong Kong: Department of Health

Study ID:

L_8479

NCT ID:

NCT00263029

Start Date:

June 2002

Completion Date:

Related Keywords:

  • Rectal Neoplasms
  • Neoplasms
  • Rectal Neoplasms

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