Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer

NCT00004256 | Completed Phase 2

• 3 other identifiers: CDR0000067503RMNHS-GMCSFEU-99041
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Head and Neck Cancer; Oral Complications; Radiation Toxicity

Keywords

stage I laryngeal cancer; stage II laryngeal cancer; recurrent laryngeal cancer; oral complications; radiation toxicity

Interventions

sargramostim BIOLOGICAL

quality-of-life assessment PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden NHS Trust

London, England, SW3 6JJ, United Kingdom

Location

Related Publications (1)

• McAleese 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 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Radiation Injuries; Laryngeal Neoplasms

Interventions

sargramostim; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Wounds and Injuries; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• J.M. Henk, MD

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2000
• First Posted: August 25, 2003
• Study Start: October 1, 1997
• Study Completion: July 1, 2006
• Last Updated: November 6, 2013

Record last verified: 2006-08

Locations

GB (1)