Clinical trial NCT00207831: Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Rectal Cancer
Stage II/III
T3 or T4 (Only Anal Extension) Rectal Cancer
N0-2
M0
Keywords: rectal cancer
neoadjuvant therapy
UFT
radiochemotherapy
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2005-09-21
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: Compare endoscopic ultrasonographic response in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone.
measure: Compare quality of life (Quality of Life Questionnaire Core 30 Items [QLQ-C 30])
measure: Compare the rate of sphincter conservation alone.
measure: Compare the safety of the chemoradiotherapy regimen to radiotherapy alone
measure: Compare the rate of resectability with negative resection margins in patients treated with this two regimen.
measure: Compare recurrence free survival and disease free survival
measure: Compare overall survival
Other outcomes:
Locations:
city: Avignon
country: France
facility: Clinique Sainte Catherine
city: Bobigny
country: France
facility: Hopital Avicenne
city: Brest
country: France
facility: Institut de Cancérologie et d'Hématologie
city: Brive La Gaillarde
country: France
facility: Centre Hospitalier
city: Chartres
country: France
facility: Centre d'Oncologie-radiothérapie d'Eure et Loir
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Clermont-ferrand
country: France
facility: Centre Médical République
city: Grenoble
country: France
facility: Clinique du Mail
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Départemental
city: Le Havre
country: France
facility: Centre Guillaume le Conquérant
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lorient
country: France
facility: Centre Hospitalier
city: LYON Cedex 08
country: France
facility: Centre léon Bérard
city: Maubeuge
country: France
facility: Centre Gray
city: Montauban
country: France
facility: Clinique du Pont de Chaume
city: Montpellier
country: France
facility: Polyclinique St Roch
city: Nimes
country: France
facility: Clinique Valdegour
city: Niort
country: France
facility: Centre Hospitalier
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rodez
country: France
facility: Centre Hospitalier
city: Rouen
country: France
facility: Centre Frédéric Joliot
city: Saint Brieuc
country: France
facility: Clinique Armoricaine de Radiologie
city: Strasbourg
country: France
facility: Centre de Radiothérapie
city: Toulouse
country: France
facility: Centre des Hautes Energies
city: Tours
country: France
facility: Clinique Fleming
Study officials:
affiliation: Institut Cancerologie de l'Ouest
name: Patrice Cellier, MD
role: STUDY_CHAIR
affiliation: Institut Cancerologie de l'Ouest
name: Rémy Barraya, MD
role: STUDY_CHAIR
affiliation: Centre des Hautes Energie, Toulouse
name: Christian Chevelle, MD
role: STUDY_CHAIR
affiliation: Institut Cancerologie de l'Ouest
name: Gérard Lorimier, MD
role: STUDY_CHAIR
affiliation: Institut Cancerologie de l'Ouest
name: Véronique Verrièle, MD
role: STUDY_CHAIR
affiliation: Institut Cancerologie de l'Ouest
name: Michèle Boisdron, Pct, PhD
role: STUDY_CHAIR
affiliation: Centre René Gauducheau, Nantes
name: Loïc Campion, MD
role: STUDY_CHAIR
References: