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

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ClinicalTrials.gov Identifier: NCT01288625
Recruitment Status : Suspended (There were IP availability issues due to which the study could not be started.)
First Posted : February 2, 2011
Last Update Posted : October 15, 2012
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited

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

Condition or disease Intervention/treatment Phase
Oral Mucositis Stomatitis Drug: Amifostine Radiation: Amifostine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2011
Actual Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Incidence and duration of oral mucositis [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 and the Research Institute of Surgery of the Third Military Medical University

Responsible Party: Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier: NCT01288625     History of Changes
Other Study ID Numbers: SUN-2011-DP
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: October 2012

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
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs