Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine
NCT ID: NCT01288625
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
Amifostine
500 mg sc, qod, 3 times per week
Amifostine
500mg rinsing wash, qod, 3 times per week
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
Amifostine
500 mg sc, qod, 3 times per week
Amifostine
500mg rinsing wash, qod, 3 times per week
Control group
Radiation treatment 1.8-2.0 Gy/day × 30-35 times
Amifostine
500 mg sc, qod, 3 times per week
Amifostine
500mg rinsing wash, qod, 3 times per week
Interventions
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Amifostine
500 mg sc, qod, 3 times per week
Amifostine
500mg rinsing wash, qod, 3 times per week
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Wang ge
Role: PRINCIPAL_INVESTIGATOR
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Countries
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Other Identifiers
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SUN-2011-DP
Identifier Type: -
Identifier Source: org_study_id