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

Sun Pharma

Status and phase: Withdrawn; Phase 4

Conditions: Stomatitis; Oral Mucositis

Treatments: Radiation: Amifostine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01288625

SUN-2011-DP

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Cytofos group A

Experimental group

Description:

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

Treatment:

Radiation: Amifostine

Radiation: Amifostine

Cytofos group B

Experimental group

Description:

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

Treatment:

Radiation: Amifostine

Radiation: Amifostine

Control group

Active Comparator group

Description:

Radiation treatment 1.8-2.0 Gy/day × 30-35 times

Treatment:

Radiation: Amifostine

Radiation: Amifostine