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

Alternate Title

Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage III Non-small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	adult	NCI	SWOG-9416 CAN-NCIC-BR11, CLB-9495, E-S9416, NCCTG-9416, INT-0160, NCT00002642, BR11

Objectives

I.  Assess the feasibility and toxic effects of 2 courses of 
cisplatin/etoposide given concurrently with continuous, fractionated chest 
irradiation followed by surgical resection and boost chemotherapy in patients 
with Pancoast tumors without mediastinal or supraclavicular nodal involvement.

II.  Assess the objective response rate, resectability rate, and proportion of 
patients free of microscopic residual disease after such treatment.

Entry Criteria

Disease Characteristics:

Histologically or cytologically proven non-small cell lung cancer of any type

Selected stage IIIA/B disease (T3-4, N0-1, M0) with superior sulcus
involvement, including:
  Apical tumor without rib or vertebral body involvement, with Pancoast
     syndrome
  Superior sulcus tumor with involvement of the chest wall (T3) and usually
     ribs 1 and 2 by CT or MRI, with or without Pancoast syndrome
  Superior sulcus tumor with involvement of vertebral body or subclavian
     vessels (T4) by CT or MRI, with or without Pancoast syndrome

  Pancoast syndrome defined:
     Arm or shoulder pain
     Neurologic findings corresponding to C8 and T1 roots or the inferior
        trunk of the brachial plexus, with or without Horner's syndrome

Single primary lesion that is measurable or evaluable by chest x-ray or CT
required

Pleural effusions allowed only if:
  Transudate with negative cytology on 2 separate thoracenteses if present
     before mediastinoscopy or exploratory thoracotomy
  Transudate or exudate with negative cytology on a single thoracentesis if
     present only after preregistration exploratory or staging thoracotomy
                                OR
  Present on CT but not chest x-ray AND considered too small to tap under CT
     or ultrasound guidance
        Thoracoscopy to assess pleural metastases strongly recommended

No mediastinal or supraclavicular nodal involvement (N2-3) established by
mediastinoscopy, mediastinotomy, thoracoscopy, or thoracotomy
  No documented single- or multi-level ipsilateral or contralateral
     mediastinal nodes whether or not enlarged nodes visible on chest x-ray or
     CT
  AP window nodes (level 5) causing vocal cord paralysis considered N2 disease
     in patients with a distinct primary tumor in the left upper lobe
        Paralysis documented by indirect laryngoscopy

No evidence of distant metastases on the following:
  Chest CT, preferably with contrast
     Thoracic spine MRI strongly recommended if CT suggests vertebral body
     invasion
  Abdominal CT including liver and adrenals, preferably with contrast
     Biopsy or aspiration cytology required to confirm diagnosis of any CT or
     MRI abnormality
        MRI and ultrasound sufficient to diagnose benign cysts or hemangiomas
  Brain CT or MRI with contrast
  Bone scan with x-rays or MRI, and/or aspiration cytology of any abnormality
     (unless related to chest wall extension of primary)

No pericardial effusions or superior vena cava syndrome

Patient considered candidate for potential pulmonary resection by attending
thoracic surgeon

Prior/Concurrent Therapy:

No prior chemotherapy or radiotherapy for lung cancer
Prior exploratory thoracotomy allowed only for diagnostic or staging purposes

Patient Characteristics:

Age:
  Adult

Performance status:
  SWOG 0-2
     Albumin at least 0.85 times normal and no greater than 10% tumor-related
     weight loss required in patients with performance status 2

Hematopoietic:
  WBC at least 4,000
  Platelets at least normal

Hepatic:
  (unless abnormality due to documented benign disease)
  Bilirubin no greater than 1.5 times normal
  ALT or AST no greater than 1.5 times normal

Renal:
  Creatinine clearance (calculated) at least 50 mL/min

Cardiovascular:
  No poorly controlled disease, e.g.:
     Myocardial infarction within 3 months
     Active angina
     Arrhythmia
     Clinically evident congestive heart failure

Pulmonary:
  FEV1 at least 2.0 liters OR
     Predicted postresection FEV1 greater than 800 mL based on quantitative
        lung V/Q scan
     DLCO at least 50% of predicted (corrected for hemoglobin) and recommended
        if pneumonectomy planned

Other:
  No symptomatic peripheral neuropathy
  No peptic ulcer disease unless medically controlled
  Acceptance of potential worsening of any existing clinical hearing loss
  No second malignancy within 5 years except:
     Adequately treated nonmelanomatous skin cancer
     Adequately treated in situ cervical cancer
  No pregnant or nursing women
  Effective contraception required of fertile women

Expected Enrollment

99 patients will be accrued over 2-4 years.

Outline

All patients receive Induction on Regimen A and, in the absence of 
progression, proceed to Regimen B, then C.  Patients who refuse or are 
medically unfit for surgery following Regimen A proceed directly to Regimen C.

Regimen A:  2-Drug Combination Chemotherapy plus Radiotherapy.  Cisplatin, 
CDDP, NSC-119875; Etoposide, VP-16, NSC-141540; plus irradiation of the tumor 
and ipsilateral supraclavicular region using megavoltage equipment (photons 
with peak energies of 4-15 MV).

Regimen B:  Surgery.  Tumor resection.

Regimen C:  2-Drug Combination Chemotherapy.  CDDP; VP-16.

Rusch VW, Giroux DJ, Kraut MJ, et al.: Induction chemoradiation and surgical resection for superior sulcus non-small-cell lung carcinomas: long-term results of Southwest Oncology Group Trial 9416 (Intergroup Trial 0160). J Clin Oncol 25 (3): 313-8, 2007.[PUBMED Abstract]

Rusch VW, Giroux D, Kraut MJ, et al.: Induction chemoradiotherapy and surgical resection for non-small cell lung carcinomas of the superior sulcus (pancoast tumors): mature results of Southwest Oncology Group trial 9416 (Intergroup trial 0160). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2548, 2003.

Rusch VW, Giroux DJ, Kraut MJ, et al.: Induction chemoradiation and surgical resection for non-small cell lung carcinomas of the superior sulcus: Initial results of Southwest Oncology Group Trial 9416 (Intergroup Trial 0160). J Thorac Cardiovasc Surg 121 (3): 472-83, 2001.[PUBMED Abstract]

Kraut MJ, Rusch VW, Crowley JJ, et al.: Induction chemoradiation plus surgical resection is feasible and highly effective treatment for Pancoast tumors: initial results of SWOG 9416 (Intergroup 0160) trial. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A1906. 487a, 2000.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Valerie Rusch, MD, FACS, Protocol chair		Ph: 212-639-8695; 800-525-2225

Eastern Cooperative Oncology Group

David Johnson, MD, Protocol chair		Ph: 615-343-9454; 800-811-8480 Email: david.h.johnson@vanderbilt.edu

Cancer and Leukemia Group B

Lawrence Shulman, MD, Protocol chair		Ph: 617-632-2277; 866-790-4500 Email: Lawrence_Shulman@dfci.harvard.edu

NCIC-Clinical Trials Group

Ronald Burkes, MD, FRCPC, Protocol chair		Ph: 416-586-5117

North Central Cancer Treatment Group

Claude Deschamps, MD, Protocol chair		Ph: 507-284-8462 Email: deschamps.claude@mayo.edu

Registry Information
Official Title		INDUCTION CHEMORADIOTHERAPY FOLLOWED BY SURGICAL RESECTION FOR NON-SMALL CELL LUNG CANCER INVOLVING THE SUPERIOR SULCUS (PANCOAST TUMORS): A PHASE II TRIAL
Trial Start Date		1995-04-15
Registered in ClinicalTrials.gov		NCT00002642
Date Submitted to PDQ		1995-04-15
Information Last Verified		2007-04-20
NCI Grant/Contract Number		U10-CA32102