Status:
TERMINATED
Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma
Lead Sponsor:
Institut Cancerologie de l'Ouest
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Rectal Cancer
Stage II/III
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a rad...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT00207831
Start Date
July 1 2004
End Date
February 1 2008
Last Update
March 25 2020
Active Locations (27)
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1
Clinique Sainte Catherine
Avignon, France, 84000
2
Hopital Avicenne
Bobigny, France, 93
3
Institut de Cancérologie et d'Hématologie
Brest, France, 29609
4
Centre Hospitalier
Brive-la-Gaillarde, France, 19312