Trial UFT/RT Randomized Multicenter Phase III Randomized Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma
18 Years
80 Years
Both
Rectal Cancer, Stage II/III, T3 or T4 (Only Anal Extension) Rectal Cancer, N0-2, M0
Trial Information
Trial UFT/RT Randomized Multicenter Phase III Randomized Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma
Adenocarcinoma of the rectum
Stage II/stage III rectal cancer (if T4 only anal extension eligible)
Drug: UFT
Procedure: chemotherapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: radiation therapy
Procedure: radiosensitization
Procedure: surgery
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive adenocarcinoma of the rectum , M0, lower side < 10
cm from anal verge
- T3 or T4 disease (T4 exclusive anal extension )
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2 OR
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin < x2 UNL
Renal
- Creatinine < 150 µMol/L
Gastrointestinal
- No history of inflammatory bowel disease
- No history of difficulty or inability to take or absorb oral medications
Neurologic
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except curatively treated basal cell skin
cancer or carcinoma in situ of the cervix
- No history of psychiatric conditions or diminished mental capacity that would
preclude study compliance or giving informed consent
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior chemotherapy
Radiotherapy
- No prior radiotherapy to the pelvis
Other
- No other concurrent investigational drugs
- No other concurrent anticancer treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Compare the rate of pathologic complete response of the primary tumor in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone
Principal Investigator
Patrice Cellier, MD
Investigator Role:
Study Chair
Investigator Affiliation:
ICO Paul Papin
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CPP276
NCT ID:
NCT00207831
Start Date:
July 2004
Completion Date:
February 2008
Related Keywords:
- Rectal Cancer
- Stage II/III
- T3 or T4 (Only Anal Extension) Rectal Cancer
- N0-2
- M0
- rectal cancer
- neoadjuvant therapy
- UFT
- radiochemotherapy
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Rectal Neoplasms
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