Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma

Study Overview
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Brief Summary
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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
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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

Official Title
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Trial UFT/RT Randomized Multicenter Phase III Randomized Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma

Conditions
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Rectal Cancer, Stage II/III, T3 or T4 (Only Anal Extension) Rectal Cancer, N0-2, M0

Intervention / Treatment
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* Drug: Tegafur and Uracil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tegafur uracile + radiotherapy<br> | Drug: Tegafur and Uracil<br> <br> |
| Active Comparator: radiotherapy<br> | Drug: Tegafur and Uracil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare endoscopic ultrasonographic response in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone. |  |  | 
| 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 the rate of resectability with negative resection margins in patients treated with this two regimen. |  |  | 
| Compare recurrence free survival and disease free survival |  |  | 
| Compare overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer, neoadjuvant therapy, UFT, radiochemotherapy