Clinical trial · Interventional
Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine
Prospective, Open-label, Randomized, Control Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine
NCT01288625CI-TRIAL-00055067withdrawnPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): There were IP availability issues due to which the study could not be started.
Summary
Brief summary (as posted)
The purpose of this study is to compare the incidence of stomatitis when treating with amifostine before radiation treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
| Stomatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amifostine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cytofos group A
- 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
- interventionNames
- Drug: Amifostine
- Radiation: Amifostine
- type
- EXPERIMENTAL
- label
- Cytofos group B
- 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
- interventionNames
- Drug: Amifostine
- Radiation: Amifostine
- type
- ACTIVE_COMPARATOR
- label
- Control group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.