Randomized phase II study of amifostine mucosal protection by either subcutaneous injection or rapid IV bolus for patients with inoperable stage II-IIIA/B or stage IV non-small cell lung cancer with oligometastases receiving concurrent radiochemotherapy with carboplatin and paclitaxel followed by optional consolidative chemotherapy: a follow-up study after RTOG 98-01.

Author(s): Werner-Wasik M, Langer C, Movsas B

Affiliation(s): Kimmel Cancer Center of Jefferson Medical College, Philadelphia, PA 19107, USA. maria.werner-wasik@mail.tju.edu

Publication date & source: 2004-12, Semin Oncol., 31(6 Suppl 18):47-51.

Publication type: Clinical Trial; Clinical Trial, Phase II; Multicenter Study; Randomized Controlled Trial; Review

While concurrent chemoradiotherapy is a standard treatment for good-performance patients with non-small cell lung cancer, acute esophagitis is a frequent toxicity. The incidence of severe acute esophagitis > or = grade 3 in patients treated with standard (once-daily) radiation therapy alone is 1.3%, increasing to 14% to 25% with the addition of concurrent chemotherapy, and 24% to 34% for the combination of hyperfractionated (twice-daily) radiation therapy plus concomitant chemotherapy. Although esophagitis is almost never a cause of mortality, it results in significant morbidity and may force treatment breaks, which are associated with inferior outcome in non-small cell lung cancer. Substantial investigative efforts to prevent or ameliorate esophagitis have been conducted. We describe herein the rationale/study design for a multi-institutional, phase II randomized study to evaluate either daily subcutaneous or intravenous bolus infusions of amifostine in patients with non-small cell lung cancer who receive standard fractionated thoracic radiation therapy concurrently with weekly paclitaxel and carboplatin chemotherapy.