Phase II intergroup trial for superior sulcus lung cancer (Pancoast tumor) with concurrent chemoradiation as induction therapy

Originating Group

SWOG 9416

P.I.: Dr.V.Rusch

Participating Groups

CALGB 9495 Dr. F. Detterbeck
ECOG S9416 Dr. M. Giddberg
NCIC CTGBR.11 Dr. T. Winton

Objectives

  1. To assess the feasibility and toxicity of treating patients who have Pancoast tumors without mediastinal or supraclavicular nodal involvement (T3-4, N0-1) with cisplatin and VP-16 for two cycles, concurrent with a program of continuous, fractionated chest radiation followed by surgical resection and boost chemotherapy.
  2. To assess the objective response rate, resectability rate, and proportion of patients free of microscopic residual disease after such an approach.

Eligibility

  1. Histological or cytological evidence of Stage IIIa (T3N0-1) or Stage IIIb (T4N0-1) non-small cell lung cancer of the superior sulcus without rib or vertebral body involvement, or superior sulcus tumors with involvement of the chest wall (T3), or superior sulcus tumors with invasion of the vertebral bodies or involvement of the subclavian vessels (T4). Each may or may not be associated with the Pancoast syndrome. Patients with mediastinal or supraclavicular nodal involvement (N2-3) are not eligible for this study.
  2. Patients with two or more parenchymal lesions in the same lung or in both lungs are ineligible.
  3. Mediastinal exploration is required to establish eligibility.
  4. Patients with pleural effusions are eligible if : when present before mediastinoscopy or exploratory thoracotomy they are transudative with negative cytology on two separate thoracenteses. If present only after pre-registration exploratory or staging thoracotomy but not before, effusions may either be transudate or exudate with negative cytology on a single thoracentesis.
  5. Patients with either pericardial effusions or superior vena cava syndrome are ineligible.
  6. No evidence of distant metastatic disease on CT of the abdomen and head or on bone scan.
  7. No prior chemotherapy or radiotherapy for lung cancer. Prior thoracotomy is allowed only for diagnosis or staging purposes.
  8. No prior malignancy is allowed except for adequately treated basal cell or swuamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.

Schema

Comments

trial closed 11/98 accrual target of 99 patients reached 8/99 Publication : Induction chemoradiation and surgical resection for non-small cell lung carcinomas of the superior sulcus: Initial Results of Southwest Oncology Group Trial 9416 (Intergroup 0160). Rusch VW, Giroux DJ, Kraut MJ, et al. JTCVS;121:472-483