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Status:

TERMINATED

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

Lead Sponsor:

Institut Cancerologie de l'Ouest

Collaborating Sponsors:

Merck Sharp & Dohme LLC

Conditions:

Rectal Cancer

Stage II/III

Eligibility:

All Genders

18-80 years

Phase:

PHASE3

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 rad...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2008

    Estimated Enrollment :

    219 Patients enrolled

    Trial Details

    Trial ID

    NCT00207831

    Start Date

    July 1 2004

    End Date

    February 1 2008

    Last Update

    March 25 2020

    Active Locations (27)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 7 (27 locations)

    1

    Clinique Sainte Catherine

    Avignon, France, 84000

    2

    Hopital Avicenne

    Bobigny, France, 93

    3

    Institut de Cancérologie et d'Hématologie

    Brest, France, 29609

    4

    Centre Hospitalier

    Brive-la-Gaillarde, France, 19312