Clinical trial NCT00004256: Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer
Official title: Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of Laryngeal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-08-25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: OBJECTIVES:

* Determine the efficacy of sargramostim (GM-CSF) in reducing the duration and severity of mucositis resulting from accelerated radiotherapy in patients with laryngeal carcinoma.
* Determine the effect of GM-CSF on quality of life aspects of these patients as assessed by nutritional status, analgesic use, and days in the hospital.

OUTLINE: This is a randomized study.

Patients receive radiotherapy in 16 fractions over 21 days. Patients are randomly allocated to one of two treatment arms before scheduled radiotherapy begins.

* Arm I: Patients receive sargramostim (GM-CSF) SC daily for 14 days beginning on day 14 of the course of radiotherapy.
* Arm II: Patients do not receive GM-CSF. Patients are followed weekly until mucositis is healed, as well as at weeks 2 and 6 following the end of radiotherapy.

PROJECTED ACCRUAL: A total of 34 patients (17 per arm) will be accrued for this study.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden NHS Trust
state: England
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: J.M. Henk, MD
role: STUDY_CHAIR
References:
citation: 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.