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

This study has been terminated.
(Terminated after interim analysis)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
ICO Paul Papin
ClinicalTrials.gov Identifier:
NCT00207831
First received: September 13, 2005
Last updated: July 20, 2010
Last verified: July 2010

September 13, 2005
July 20, 2010
July 2004
June 2007   (final data collection date for primary outcome 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
- 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.
Complete list of historical versions of study NCT00207831 on ClinicalTrials.gov Archive Site
  • 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
  • - Compare endoscopic ultrasonographic response in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone.
  • - Compare quality of life (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 recurence free survival, disease free survival
  • - Compare overall survival
Not Provided
Not Provided
 
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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rectal Cancer
  • Stage II/III
  • T3 or T4 (Only Anal Extension) Rectal Cancer
  • N0-2
  • M0
Drug: Tegafur and Uracil
  • Experimental: Tegafur uracile + radiotherapy
    Intervention: Drug: Tegafur and Uracil
  • Active Comparator: radiotherapy
    Intervention: Drug: Tegafur and Uracil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
219
February 2008
June 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00207831
CPP276
Yes
Centre Paul¨Papin, Gamelin Pr
ICO Paul Papin
Merck Sharp & Dohme Corp.
Study Chair: Patrice Cellier, MD ICO Paul Papin
Study Chair: Rémy Barraya, MD ICO Paul Papin
Study Chair: Christian Chevelle, MD Centre des Hautes Energie, Toulouse
Study Chair: Gérard Lorimier, MD ICO Paul Papin
Study Chair: Véronique Verrièle, MD ICO Paul Papin
Study Chair: Michèle Boisdron, Pct, PhD ICO Paul Papin
Study Chair: Loïc Campion, MD Centre René Gauducheau, Nantes
ICO Paul Papin
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP