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NCT00002642 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2012-10-08

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    chemoradiotherapy followed by surgery and post-surgery boost chemotherapy
    intervention Names
    1. Drug: cisplatin
    2. Drug: etoposide
    3. Procedure: conventional surgery
    4. Radiation: low-LET cobalt-60 gamma ray therapy
    label
    chemoradiotherapy followed by surgery
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. chemoradiotherapy followed by surgery
    description
    50 mg/m2, IV Days 1 and 8, two 28 day cycles prior to surgery and two 28 day cycles after surgery
    name
    cisplatin
    other Names
    1. platinol
    type
    DRUG
  2. arm Group Labels
    1. chemoradiotherapy followed by surgery
    description
    50 mg/m2, IV Days 1-5, two 28 day cycles prior to surgery and two 28 day cycles after surgery
    name
    etoposide
    other Names
    1. VP-16
    type
    DRUG
  3. arm Group Labels
    1. chemoradiotherapy followed by surgery
    description
    surgery some time between weeks 9 and 12
    name
    conventional surgery
    other Names
    1. surgery
    type
    PROCEDURE
  4. arm Group Labels
    1. chemoradiotherapy followed by surgery
    description
    180 cGy per day, Days 1-5, weekly for 5 weeks
    name
    low-LET cobalt-60 gamma ray therapy
    other Names
    1. RT
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
116
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    resectibility rate
    measure
    Feasibility
    time Frame
    9-12 weeks after study entry
secondary Outcomes
  1. description
    Toxicity assessments per Southwest Oncology Group toxicity criteria
    measure
    toxicity
    time Frame
    16-20 weeks
  2. 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.
    measure
    response rate
    time Frame
    16-20 weeks after registration
Full 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.
Source references
references
  1. 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.
    pmid
    17235046
    type
    RESULT
  2. 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.
    type
    RESULT
  3. 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.
    pmid
    11241082
    type
    RESULT
  4. 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.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        Updated: May 15, 2025
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        May 15, 2025

    Preserved source evidence · Not medical advice