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

• Sponsor: Sun Pharmaceutical Industries Limited (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT01288625
• Collaborator: (none)
• Enrollment: 0
• Arms: 3

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence and duration of oral mucositis [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sun Pharmaceutical Industries Limited
• ClinicalTrials.gov Identifier: NCT01288625
• Other Study ID Numbers: SUN-2011-DP
• First Posted: Feb 2, 2011
• Last Update Posted: Nov 17, 2021
• Last Verified: Nov 1, 2021

• 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; Amifostine

Study Results

No Results Posted as of Nov 17, 2021