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

Rectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00207831
• Other study ID #: CPP276
• Status: Terminated
• Phase: Phase 3
• Start date: July 2004
• Est. completion date: February 2008

Study information

• Verified date: March 2020
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 219
• Est. completion date: February 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tegafur and Uracil

Locations

Country	Name	City	State
France	Clinique Sainte Catherine	Avignon
France	Hopital Avicenne	Bobigny
France	Institut de Cancérologie et d'Hématologie	Brest
France	Centre Hospitalier	Brive La Gaillarde
France	Centre d'Oncologie-radiothérapie d'Eure et Loir	Chartres
France	Centre Jean Perrin	Clermont Ferrand
France	Centre Médical République	Clermont-ferrand
France	Clinique du Mail	Grenoble
France	Centre Hospitalier Départemental	La Roche Sur Yon
France	Centre Guillaume le Conquérant	Le Havre
France	Centre Oscar Lambret	Lille
France	Centre Hospitalier	Lorient
France	Centre léon Bérard	LYON Cedex 08
France	Centre Gray	Maubeuge
France	Clinique du Pont de Chaume	Montauban
France	Polyclinique St Roch	Montpellier
France	Clinique Valdegour	Nimes
France	Centre Hospitalier	Niort
France	Centre Hospitalier Universitaire	Poitiers
France	Centre Hospitalier de Cornouaille	Quimper
France	Centre Eugène Marquis	Rennes
France	Centre Hospitalier	Rodez
France	Centre Frédéric Joliot	Rouen
France	Clinique Armoricaine de Radiologie	Saint Brieuc
France	Centre de Radiothérapie	Strasbourg
France	Centre des Hautes Energies	Toulouse
France	Clinique Fleming	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare endoscopic ultrasonographic response in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone.
Secondary	Compare quality of life (Quality of Life Questionnaire Core 30 Items [QLQ-C 30])
Secondary	Compare the rate of sphincter conservation alone.
Secondary	Compare the safety of the chemoradiotherapy regimen to radiotherapy alone
Secondary	Compare the rate of resectability with negative resection margins in patients treated with this two regimen.
Secondary	Compare recurrence free survival and disease free survival
Secondary	Compare overall survival