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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
  Purpose

The purpose of this study is to compare the incidence of stomatitis when treating with amifostine before radiation treatment.


Condition Intervention Phase
Oral Mucositis
Stomatitis
 Drug: Amifostine
Radiation: Amifostine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prospective, Open-label, Randomized, Control Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

Resource links provided by NLM:

Drug Information available for: Amifostine
U.S. FDA Resources

Further study details as provided by Sun Pharmaceutical Industries Limited:

Primary Outcome Measures:
  • Incidence and duration of oral mucositis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: March 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: Amifostine
500 mg sc, qod, 3 times per week
Radiation: Amifostine
500mg rinsing wash, qod, 3 times per week
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
 Drug: Amifostine
500 mg sc, qod, 3 times per week
Radiation: Amifostine
500mg rinsing wash, qod, 3 times per week
Active Comparator: Control group
Radiation treatment 1.8-2.0 Gy/day × 30-35 times
 Drug: Amifostine
500 mg sc, qod, 3 times per week
Radiation: Amifostine
500mg rinsing wash, qod, 3 times per week

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288625

Locations
China, Chongqing
Oncology Institute of Daping Hospital, Third Military Medical University
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Sun Pharmaceutical Industries Limited
Investigators
Principal Investigator: Wang ge Daping Hospital
  More Information

No publications provided

Responsible Party: Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier: NCT01288625     History of Changes
Other Study ID Numbers: SUN-2011-DP
Study First Received: February 1, 2011
Last Updated: October 12, 2012
Health Authority: China: Institutional Review Board

Keywords provided by Sun Pharmaceutical Industries Limited:
Identify whether Cytofos can reduce the incidence and duration of HNC patients' oral mucositis caused by radiotherapy.

Additional relevant MeSH terms:
Head and Neck Neoplasms
Stomatitis
Mucositis
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013