TerminatedPhase 3

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

Stopped: Terminated after interim analysis

France219 participantsStarted 2004-07

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT00207831

SponsorInstitut Cancerologie de l'Ouest

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-06