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Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

This study has suspended participant recruitment.
(There were IP availability issues due to which the study could not be started.)
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier:
NCT01288625
First received: February 1, 2011
Last updated: October 12, 2012
Last verified: October 2012
History of Changes

February 1, 2011
October 12, 2012
March 2011
December 2011   (final data collection date for primary outcome measure)
Incidence and duration of oral mucositis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01288625 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine
Prospective, Open-label, Randomized, Control Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

The purpose of this study is to compare the incidence of stomatitis when treating with amifostine before radiation treatment.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Oral Mucositis
  • Stomatitis
  • Drug: Amifostine
    500 mg sc, qod, 3 times per week
  • Radiation: Amifostine
    500mg rinsing wash, qod, 3 times per week
  • Experimental: Cytofos group A
    Amifostine 500 mg sc, qod, 3 times per week Radiation treatment 30 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times
    Interventions:
    • Drug: Amifostine
    • Radiation: Amifostine
  • Experimental: Cytofos group B
    Amifostine 500mg rinsing wash, qod, 3 times per week Radiation treatment 5 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times
    Interventions:
    • Drug: Amifostine
    • Radiation: Amifostine
  • Active Comparator: Control group
    Radiation treatment 1.8-2.0 Gy/day × 30-35 times
    Interventions:
    • Drug: Amifostine
    • Radiation: Amifostine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
150
Not Provided
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 18-70 years old, male or female
  2. Primary treatment of phase I-IVA head and neck cancer patients, identified by histological and pathological diagnosis
  3. Postoperative patients should receive radiation treatment in 12 weeks
  4. ECOG <2
  5. Expected lifetime ≥6months
  6. No severe complications (hypertension, CHD, diabetes and psychiatric history, etc.)
  7. Not involved in other clinical trials
  8. Sign ICF

Exclusion Criteria:

  1. ECOG >2
  2. Suffered other cancers in the past 5 years
  3. Received amifostine treatment in the past 4 weeks
  4. Unable to complete treatment or sign ICF because of medical or physical reasons
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01288625
SUN-2011-DP
No
Sun Pharmaceutical Industries Limited
Sun Pharmaceutical Industries Limited
Not Provided
Principal Investigator: Wang ge Daping Hospital
Sun Pharmaceutical Industries Limited
October 2012

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