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NCT01288625 Clinical Trial

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

Oral Mucositis Clinical Trial

Official title:
Prospective, Open-label, Randomized, Control Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01288625
Other study ID # SUN-2011-DP
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated

Study information
Verified date November 2021
Source Sun Pharmaceutical Industries Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amifostine
500 mg sc, qod, 3 times per week
Radiation:
• Amifostine
500mg rinsing wash, qod, 3 times per week

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sun Pharmaceutical Industries Limited

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence and duration of oral mucositis 3 months
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