Back to results

Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma (UFT RT Phase 3)

Primary Purpose

Rectal Cancer, Stage II/III, T3 or T4 (Only Anal Extension) Rectal Cancer

Status

Terminated

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Tegafur and Uracil

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, neoadjuvant therapy, UFT, radiochemotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tegafur uracile + radiotherapy

radiotherapy

Arm Description

Outcomes

Primary Outcome Measures

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

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

Full Information

NCT ID

NCT00207831

First Posted

September 13, 2005

Last Updated

March 23, 2020

Sponsor

Institut Cancerologie de l'Ouest

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00207831

Brief Title

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

Acronym

UFT RT Phase 3

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Terminated

Why Stopped

Terminated after interim analysis

Study Start Date

July 2004 (Actual)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Cancerologie de l'Ouest

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

rectal cancer, neoadjuvant therapy, UFT, radiochemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

219 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tegafur uracile + radiotherapy

Arm Type

Experimental

Arm Title

radiotherapy

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Tegafur and Uracil

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Compare endoscopic ultrasonographic response in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone.

Title

Compare quality of life (Quality of Life Questionnaire Core 30 Items [QLQ-C 30])

Title

Compare the rate of sphincter conservation alone.

Title

Compare the safety of the chemoradiotherapy regimen to radiotherapy alone

Title

Compare the rate of resectability with negative resection margins in patients treated with this two regimen.

Title

Compare recurrence free survival and disease free survival

Title

Compare overall survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: