Ryu, J.K., Swann, S., LeVeque, F., Scarantino, C.W., Johnson, D., Chen, A., et al. (2007). The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: A double-blind placebo-controlled prospective phase III study by Radiation Therapy Oncology Group 9901. International Journal of Radiation Oncology, Biology, Physics, 67(3), 643–650.

Intervention Characteristics/Basic Study Process

Subcutaneous GM-CSF (250 mcg/m2) was started one week before radiation and stopped two weeks after completion. GM-CSF was given within two hours after each radiation fraction on Monday, Wednesday, and Friday. Doses were held on days that patients received chemotherapy.

Sample Characteristics

Patients with head and neck cancer with radiation ports on 50% or more of oral cavity or oropharynx to 60-70 Gy.

GM-CSF: n = 63
Placebo: n = 58

Setting

October 2000-September 2002
 

Measurement Instruments/Methods

  • CTC acute toxicity scale
  • Severity and duration of mucositis
  • Quality of life (QOL): University of Washington Head and Neck symptom questionnaire
     

Results

No statistical differences in mucositis or QOL scores

Limitations

Some participants discontinued study because of unspecified “toxicity”. Drug supply ended before all patients completed therapy.