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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

sargramostim

quality-of-life assessment

radiation therapy

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring stage I laryngeal cancer, stage II laryngeal cancer, recurrent laryngeal cancer, oral complications, radiation toxicity

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Royal Marsden NHS Trust

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004256

First Posted

January 28, 2000

Last Updated

November 5, 2013

Sponsor

Royal Marsden NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT00004256

Brief Title

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

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Completed

Study Start Date

October 1997 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Royal Marsden NHS Foundation Trust

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer, Oral Complications, Radiation Toxicity

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

sargramostim

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J.M. Henk, MD

Organizational Affiliation

Royal Marsden NHS Foundation Trust

Official's Role

Study Chair

Facility Information:

Facility Name

Royal Marsden NHS Trust

City

London

State/Province

England

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

16823067

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.

Results Reference

result

Head and Neck Cancer, Oral Complications, Radiation Toxicity

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial