Trial | NCT00207831  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    219
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.
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
Study Started
Jul 31
2004
Primary Completion
Jun 30
2007
Study Completion
Feb 29
2008
Last Update
Mar 25
2020

Drug Tegafur and Uracil

Tegafur uracile + radiotherapy Experimental

radiotherapy Active Comparator

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
No Results Posted