M0, N0-2, Rectal Cancer, Stage II/III, T3 or T4 (Only Anal Extension) Rectal Cancer
Conditions
Keywords
rectal cancer, neoadjuvant therapy, UFT, radiochemotherapy
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 radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation therapy before surgery may shrink the tumor so it can be removed. PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer.
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 Procedure: radiation therapy Procedure: radiosensitization Procedure: surgery
Interventions
DRUGTegafur and Uracil
Sponsors
Merck Sharp & Dohme LLC
Institut Cancerologie de l'Ouest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare quality of life (Quality of Life Questionnaire Core 30 Items [QLQ-C 30]) | — |
| Compare the rate of sphincter conservation alone. | — |
| Compare the safety of the chemoradiotherapy regimen to radiotherapy alone | — |
| Compare endoscopic ultrasonographic response in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone. | — |
| Compare recurrence free survival and disease free survival | — |
| Compare overall survival | — |
| Compare the rate of resectability with negative resection margins in patients treated with this two regimen. | — |
Countries
France
Outcome results
None listed