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SWOG-9416: Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage III Non-small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
etoposide
conventional surgery
low-LET cobalt-60 gamma ray therapy
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemoradiotherapy followed by surgery

Arm Description

chemoradiotherapy followed by surgery and post-surgery boost chemotherapy

Outcomes

Primary Outcome Measures

Feasibility
resectibility rate

Secondary Outcome Measures

toxicity
Toxicity assessments per Southwest Oncology Group toxicity criteria
response rate
Greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of disease. No new lesions.

Full Information

First Posted
November 1, 1999
Last Updated
October 5, 2012
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, NCIC Clinical Trials Group, North Central Cancer Treatment Group
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1. Study Identification

Unique Protocol Identification Number
NCT00002642
Brief Title
SWOG-9416: Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage III Non-small Cell Lung Cancer
Official Title
Induction Chemoradiotherapy Followed by Surgical Resection for Non-small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors): A Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 1995 (undefined)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, NCIC Clinical Trials Group, North Central Cancer Treatment Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy using cisplatin and etoposide, radiation therapy, and surgery, with adjuvant therapy using cisplatin and etoposide, in treating patients who have stage III non-small cell lung cancer.
Detailed Description
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. 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. PROJECTED ACCRUAL: 99 patients will be accrued over 2-4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chemoradiotherapy followed by surgery
Arm Type
Experimental
Arm Description
chemoradiotherapy followed by surgery and post-surgery boost chemotherapy
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
platinol
Intervention Description
50 mg/m2, IV Days 1 and 8, two 28 day cycles prior to surgery and two 28 day cycles after surgery
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
VP-16
Intervention Description
50 mg/m2, IV Days 1-5, two 28 day cycles prior to surgery and two 28 day cycles after surgery
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Other Intervention Name(s)
surgery
Intervention Description
surgery some time between weeks 9 and 12
Intervention Type
Radiation
Intervention Name(s)
low-LET cobalt-60 gamma ray therapy
Other Intervention Name(s)
RT
Intervention Description
180 cGy per day, Days 1-5, weekly for 5 weeks
Primary Outcome Measure Information:
Title
Feasibility
Description
resectibility rate
Time Frame
9-12 weeks after study entry
Secondary Outcome Measure Information:
Title
toxicity
Description
Toxicity assessments per Southwest Oncology Group toxicity criteria
Time Frame
16-20 weeks
Title
response rate
Description
Greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of disease. No new lesions.
Time Frame
16-20 weeks after registration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy for lung cancer Prior exploratory thoracotomy allowed only for diagnostic or staging purposes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie W. Rusch, MD, FACS
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David H. Johnson, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lawrence N. Shulman, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ronald L. Burkes, MD, FRCPC
Organizational Affiliation
Mount Sinai Hospital, Canada
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Claude Deschamps, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Vanderbilt Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17235046
Citation
Rusch VW, Giroux DJ, Kraut MJ, Crowley J, Hazuka M, Winton T, Johnson DH, Shulman L, Shepherd F, Deschamps C, Livingston RB, Gandara D. 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. 2007 Jan 20;25(3):313-8. doi: 10.1200/JCO.2006.08.2826.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
11241082
Citation
Rusch VW, Giroux DJ, Kraut MJ, Crowley J, Hazuka M, Johnson D, Goldberg M, Detterbeck F, Shepherd F, Burkes R, Winton T, Deschamps C, Livingston R, Gandara D. 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. 2001 Mar;121(3):472-83. doi: 10.1067/mtc.2001.112465.
Results Reference
result
Citation
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.
Results Reference
result

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SWOG-9416: Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage III Non-small Cell Lung Cancer

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