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

Alternate Title

Combination Chemotherapy Plus Radiation Therapy With or Without Gefitinib in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Not specified NCI SWOG-S0023 CAN-NCIC-BR15, NCCTG-S0023, S0023, NCT00020709, BR15

Special Category: CTSU trial

Objectives

1. Compare cisplatin, etoposide, radiotherapy, and docetaxel with or without gefitinib, in terms of improving overall survival and progression-free survival, in patients with unresectable stage III non-small cell lung cancer.
2. Determine the toxicity profile of gefitinib in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed newly diagnosed single, primary bronchogenic non-small cell lung cancer (NSCLC)
  • Adenocarcinoma
  • Non-lobar and non-diffuse bronchoalveolar cell carcinoma
  • Large cell carcinoma
  • Squamous cell carcinoma



• Unresectable stage IIIA disease
  • Histologically or cytologically confirmed N2 status
  • Multiple and/or bulky mediastinal lymph nodes on CT scan or x-ray
  • Ineligible for induction chemotherapy or chemoradiotherapy followed by surgical resection
  • Ineligible for or refused participation in SWOG-9336

  OR




• Stage IIIB disease
  • Pathologically or radiographically documented positive N3 nodes
    • No positive supraclavicular or scalene lymph nodes with disease extending up into the cervical region

    OR

  • Any documented T4 lesions invading the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina
    • Mediastinal involvement without organ involvement allowed if soft tissue mass extends directly into the mediastinum
    • Radiographic criteria for involvement of main pulmonary artery allowed if mediastinal soft tissue mass is present



• Single primary parenchymal lesion
  • No other lesions on same or opposite sides of the lung
  • No metastatic disease involving the contralateral chest, liver, or adrenals by CT scan of upper abdomen



• No malignant pleural or pericardial effusions
  • Pleural effusions visible only on CT scan or too small to tap allowed
  
  
  



• Measurable or evaluable disease by CT scan, MRI, x-ray, or physical exam



• No brain metastases

Prior/Concurrent Therapy:

Biologic therapy:

• No concurrent colony-stimulating factors during induction therapy

Chemotherapy:

• See Disease Characteristics
• No prior chemotherapy for NSCLC

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy for NSCLC

Surgery:

• No prior surgical resection of NSCLC
• Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar diagnostic or staging surgery allowed

Patient Characteristics:

Age:

• Not specified

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Not specified

Renal:

• Creatinine clearance at least 50 mL/min

Pulmonary:

• FEV₁ at least 2.0 L

  OR

• FEV₁ less than 2.0 L if predicted FEV₁ of the contralateral lung is greater than 800 mL by quantitative split function testing

Other:

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other concurrent non-cancer-related illness that would preclude study therapy
• Not pregnant or nursing
• Fertile patients must use effective contraception

Expected Enrollment

A total of 840 patients will be accrued for this study within 3.5 years.

Outline

This is a randomized, double-blind, multicenter study. Patients are stratified according to performance status (0 vs 1), stage (stage IIIA vs IIIB), measurability of lesion (measurable vs nonmeasurable), and histologic subtype (squamous vs nonsquamous).

Patients receive induction therapy comprising cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning within 24 hours after starting chemotherapy, patients receive concurrent induction radiotherapy 5 days a week for 5 weeks and then boost radiotherapy 5 days a week for 1.5 weeks.

Beginning approximately 4-8 weeks after completion of chemoradiotherapy, patients with stable or responding disease receive consolidation therapy comprising docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 3 courses.

Patients with stable or responding disease are randomized to one of two treatment arms for maintenance therapy. Patients begin maintenance therapy approximately 4-7 weeks after completion of consolidation therapy.

• Arm I: Patients receive oral gefitinib daily.



• Arm II: Patients receive oral placebo daily.

In both arms, maintenance therapy continues for a maximum of 5 years in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 5 years and then annually for 5 years.

Kelly K, Chansky K, Gaspar LE, et al.: Phase III trial of maintenance gefitinib or placebo after concurrent chemoradiotherapy and docetaxel consolidation in inoperable stage III non-small-cell lung cancer: SWOG S0023. J Clin Oncol 26 (15): 2450-6, 2008.[PUBMED Abstract]

Kelly K, Chansky K, Gaspar LE, et al.: Updated analysis of SWOG 0023: a randomized phase III trial of gefitinib versus placebo maintenance after definitive chemoradiation followed by docetaxel in patients with locally advanced stage III non-small cell lung cancer. [Abstract] J Clin Oncol 25 (Suppl 18): A-7513, 388s, 2007.

Gaspar LE, McCoy J, Kelly K, et al.: Analysis of V20 and radiation pneumonitis on SWOG0023: a phase III trial of concurrent chemoradiation and docetaxel consolidation in stage III non-small cell lung cancer. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-108, S61-2, 2006.

Kelly K, Gaspar LE, Chansky K, et al.: Low incidence of pneumonitis on SWOG 0023: a preliminary analysis of an ongoing phase III trial of concurrent chemoradiotherapy followed by consolidation docetaxel and Iressa/placebo maintenance in patients with inoperable stage III non-small cell lung cancer. [Abstract] J Clin Oncol 23 (Suppl 16): A-7058, 634s, 2005.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Karen Kelly, MD, Protocol chair		Ph: 303-724-3903; 800-473-2288 Email: karen.kelly@uchsc.edu

North Central Cancer Treatment Group

James Jett, MD, Protocol chair		Ph: 507-284-2511

NCIC-Clinical Trials Group

Yee Ung, MD, FRCPC, Protocol chair		Ph: 416-480-4951 Email: yee.ung@sunnybrook.ca

Registry Information
Official Title		A Phase III Trial Of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed By Maintenance Therapy With ZD 1839 Or Placebo In Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
Trial Start Date		2001-06-15
Registered in ClinicalTrials.gov		NCT00020709
Date Submitted to PDQ		2001-05-03
Information Last Verified		2004-11-01
NCI Grant/Contract Number		CA32102

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