Clinical trial · Interventional
Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer
Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of Laryngeal Cancer
NCT00004256CI-TRIAL-00012568completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as sargramostim may protect normal cells from the side effects of radiation therapy. PURPOSE: Randomized phase II trial to determine the effectiveness of sargramostim in preventing mucositis in patients who are receiving radiation therapy for laryngeal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Complications | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of laryngeal cancer with intention to treat by radiotherapy using a 16 fraction 3 week scheme * Stage I or II * No known CNS disease PATIENT CHARACTERISTICS: Age: * 20 to 80 Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Hepatic function normal Renal: * Renal function normal Other: * Not pregnant or nursing * No serious active infection requiring antibiotic therapy * No autoimmune disease * No known seizures * No psychosocial factors that would preclude study compliance * No allergies to sargramostim (GM-CSF) * Willingness to cooperate for regular mirror examination of the larynx PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * No concurrent chemotherapy Endocrine therapy: * No prior or concurrent corticosteroids * No concurrent hormonal therapy Radiotherapy: * See Disease Characteristics Surgery: * No major organ allografts Other: * No other concurrent investigational drugs
References
Publications (1)
- RESULTMcAleese JJ, Bishop KM, A'Hern R, Henk JM. Randomized phase II study of GM-CSF to reduce mucositis caused by accelerated radiotherapy of laryngeal cancer. Br J Radiol. 2006 Jul;79(943):608-13. doi: 10.1259/bjr/55190439. PMID 16823067