Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	SWOG-8805

Objectives

I.  Determine the feasibility and toxicity of treating patients with Stage III 
non-small cell lung cancer with cisplatin/etoposide for two cycles, concurrent 
with a program of continuous, fractionated chest and optional whole-brain 
irradiation, followed by surgical resection.
II.  Assess the objective response rate, resectability rate, and proportion of 
patients free of microscopic residual disease after such an approach.
III.  Assess whether immunocytochemical analysis and/or DNA analysis (ploidy, 
proliferative fraction) define subset(s) of patients who benefit from this 
combined modality approach, and potentially assess the impact of 
chemoradiotherapy on the ploidy of the tumor.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 18 years of age 
with regionally advanced non-small cell lung cancer (squamous, adeno-, and 
large cell carcinoma); this includes Stage IIIb and selected Stage IIIa 
(T1-3N2) tumors.  Eligibility for this study may be established by any one or 
more of the following:  positive N2 lymph nodes; positive N3 lymph nodes 
(those with positive supraclavicular lymph nodes must not have disease 
extending into the cervical region and must have no evidence of metastatic 
disease according to the criteria described below); lesions demonstrated to be 
T4 by virtue of documented recurrent laryngeal nerve involvement, direct 
extension into the trachea at bronchoscopy, or direct extension into the 
mediastinum at mediastinoscopy or exploratory thoracotomy (written 
documentation of direct extension must be provided in the operative report); 
or T3 lesions by virtue of superior sulcus or direct chest wall involvement, 
but only if N2 or N3 disease is found by mediastinoscopy.  Mediastinal 
adenopathy or direct mediastinal invasion by the primary must be confirmed by 
mediastinoscopy or exploratory thoracotomy and not by CT scan findings alone, 
and there must be histologic proof of non-small cell lung cancer; the only 
exceptions to these criteria are the case of a T4 lesion as above, for which a 
cytology specimen from the primary is acceptable, or the case of a patient 
already having histologic proof of non-small cell lung cancer, for whom 
cytologic proof of N2 or N3 involvement by fine needle or Wang needle 
aspiration is acceptable.  There must be no evidence of metastatic disease 
after performance of the following tests:  history and physical examination; 
WBC including differential and platelet count; chemistry battery including 
alkaline phosphatase, SGOT or SGPT, bilirubin, albumin, and calcium; chest 
x-ray; CT of brain with contrast or MRI scan of brain; CT of upper abdomen and 
chest to exclude metastatic disease involving the liver, adrenals, or 
contralateral chest (biopsy or aspiration cytology is strongly recommended to 
confirm the diagnosis of CT abnormalities that may represent metastatic 
disease); and bone scan (abnormalities on bone scan should be further 
evaluated by appropriate plain radiographs or by aspiration cytology or both 
in order to rule out metastatic disease; a bone scan abnormality with normal 
radiograph is considered metastatic disease unless biopsied or otherwise 
clinically explained).  Patients with small cell lung cancer, bronchoalveolar 
carcinoma with lobar or multilobar involvement, T4 disease by virtue of 
pleural seeding or pleural effusion, or superior vena caval syndrome are not 
eligible.  Patients must not have received any prior chemotherapy or 
radiotherapy and must be considered medically to be a candidate for surgery as 
determined by the attending thoracic surgeon.  Measurable or evaluable tumor 
by chest x-ray or CT scan is required, as is a SWOG performance status of 2 or 
better and a life expectancy of at least 8 weeks.  Patients must have WBC of 
at least 4,000, platelets at least 100,000, and serum creatinine no more than 
1.6 mg/dl or creatinine clearance at least 50 ml/minute; unless there is 
benign liver disease, serum bilirubin and SGOT must be no greater than 1.2 
times institutional normal and alkaline phosphatase must be no greater than 
1.5 times institutional normal.  If the preregistration FEV1 is not greater 
than 2.0 liters, the predicted postresection FEV1 must be over 800 cc based on 
quantitative lung V/Q scan.  Prior malignant disease other than inactive 
cervical carcinoma in situ or inactive nonmelanomatous skin cancer or other 
cancer if patient has been disease free for at least 5 years excludes, as does 
the presence of any other medical illnesses that cannot be adequately 
controlled with appropriate medication (e.g., myocardial infarction within the 
previous 3 months and refractory congestive heart failure).

Expected Enrollment

100 patients will be accrued over an estimated 2 years.

Outline

Nonrandomized study.  All patients are treated on Regimen A; those with stable 
or responding disease then undergo surgery on Regimen B.  Patients with 
residual disease following surgery are treated on Regimen C.
Regimen A:  2-Drug Combination Chemotherapy plus Radiotherapy.  Cisplatin, 
CDDP, NSC-119875; Etoposide, VP-16, NSC-141540; plus chest irradiation using 
supervoltage equipment of 4 MeV or greater (Co60 is not allowed, and electrons 
may be used only for supraclavicular treatment) and optional prophylactic 
cranial irradiation.
Regimen B:  Surgery.  Tumor resection.
Regimen C:  Radiotherapy plus 2-Drug Combination Chemotherapy.  Tumor boost 
irradiation; plus CDDP; VP-16.

Albain K, Rusch V, Crowley J, et al.: Long-term survival after concurrent cisplatin/etoposide (PE) plus chest radiotherapy (RT) followed by surgery in bulky, stages IIIA(N2) and IIIB non-small cell lung cancer (NSCLC): six-year outcomes from Southwest Oncology Group Study 8805. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A1801, 467a, 1999.

Albain KS, Rusch VW, Crowley JJ, et al.: Concurrent cisplatin/etoposide plus chest radiotherapy followed by surgery for stages IIIA (N2) and IIIB non-small-cell lung cancer: mature results of Southwest Oncology Group phase II study 8805. J Clin Oncol 13 (8): 1880-92, 1995.[PUBMED Abstract]

Albain K, Rusch V, Crowley J, et al.: Concurrent cisplatin/etoposide (PE) + chest radiation (CRT) followed by surgery for stages 3A(N2) and 3B non-small cell lung cancer: completed analysis of SWOG-8805. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-1120, 337, 1994.

Rusch VW, Albain KS, Crowley JJ, et al.: Neoadjuvant therapy: a novel and effective treatment for stage IIIb non-small cell lung cancer. Southwest Oncology Group. Ann Thorac Surg 58 (2): 290-4; discussion 294-5, 1994.[PUBMED Abstract]

Rusch VW, Albain KS, Crowley JJ, et al.: Surgical resection of stage IIIA and stage IIIB non-small-cell lung cancer after concurrent induction chemoradiotherapy. A Southwest Oncology Group trial. J Thorac Cardiovasc Surg 105 (1): 97-104; discussion 104-6, 1993.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Kathy Albain, MD, Protocol chair		Ph: 708-327-3304 Email: kalbain@lumc.edu