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

Alternate Title

Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CALGB-30105 NCT00033553

Objectives

1. Compare the overall response rate, failure-free survival, and survival of patients with inoperable stage IIIA or IIIB non-small cell lung cancer treated with paclitaxel and carboplatin with concurrent 3-dimensional conformal radiotherapy (3-D XRT) vs gemcitabine and carboplatin with concurrent 3-D XRT.
2. Compare the toxicity of these regimens in these patients.
3. Compare the pattern of failure (locoregional vs distant failure) in patients treated with these regimens.
4. Determine the feasibility of delivering 3-D XRT to patients in this multicenter study.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Squamous cell carcinoma
  • Adenocarcinoma, including bronchoalveolar cell carcinoma
  • Large cell anaplastic carcinoma, including giant and clear cell carcinoma
• Inoperable stage IIIA or IIIB disease
• No direct invasion of vertebral body
  • Tumors adjacent to a vertebral body without bone invasion allowed if all gross disease can be encompassed in radiotherapy boost field
• Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in radiotherapy boost field
• No scalene, supraclavicular, or contralateral hilar node involvement
• Transudate, cytologically negative, non-bloody pleural effusion allowed if it can be encompassed in radiotherapy field
  • No exudative, bloody, or cytologically malignant pleural effusion
  • Evidence of pleural effusion by chest CT scan but not chest x-ray that is too small to tap allowed
• At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques

    OR

  • At least 10 mm by spiral CT scan
  • The following are not considered measurable disease:
    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Abdominal masses that are not confirmed and followed by imaging techniques
    • Cystic lesions
    • Tumor lesions in a previously irradiated field

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for NSCLC
• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy except steroids for adrenal failure or septic shock, hormones for non-disease-related conditions (e.g., insulin for diabetes), or glucocorticosteroids as antiemetics

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy for NSCLC

Surgery:

• At least 2 weeks since prior exploratory thoracotomy

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin less than 1.5 mg/dL
• AST less than 2 times upper limit of normal

Renal:

• Creatinine clearance 20-130 mL/min for females
• Creatinine clearance 20-150 mL/min for males

Pulmonary:

• FEV1 at least 1.2 L

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other currently active malignancy (defined as completed prior therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer

Expected Enrollment

A total of 82 patients (41 per treatment arm) will be accrued for this study within 9 months.

Outline

This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes once weekly and 3-dimensional conformal radiotherapy (3-D XRT) once daily 5 days a week. Treatment repeats weekly for 7 courses.
• Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive gemcitabine IV over 30 minutes twice weekly and 3-D XRT as in arm I. Treatment repeats weekly for 7 courses.

In both arms, treatment continues in the absence of disease progression.

Patients are followed every 2 months for 2 years, every 4 months for 2 years, and then annually for 2 years.

Socinski MA, Blackstock AW, Bogart JA, et al.: Randomized phase II trial of induction chemotherapy followed by concurrent chemotherapy and dose-escalated thoracic conformal radiotherapy (74 Gy) in stage III non-small-cell lung cancer: CALGB 30105. J Clin Oncol 26 (15): 2457-63, 2008.[PUBMED Abstract]

Blackstock AW, Socinski MA, Bogart J, et al.: Induction (Ind) plus concurrent (Con) chemotherapy with high-dose (74 Gy) 3-dimensional (3-D) thoracic radiotherapy (TRT) in stage III non-small cell lung cancer (NSCLC): preliminary report of Cancer and Leukemia Group B (CALGB) 30105. [Abstract] J Clin Oncol 24 (Suppl 18): A-7042, 374s, 2006.

Blackstock AW, Socinski MA, Gu L, et al.: Initial pulmonary toxicity evaluation of chemoradiotherapy (CRT) utilizing 74 Gy 3-dimensional (3-D) thoracic radiation in stage III non-small cell lung cancer (NSCLC): a Cancer and Leukemia Group B (CALGB) randomized phase II trial. [Abstract] J Clin Oncol 23 (Suppl 16): A-7060, 635s, 2005.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Arthur William Blackstock, MD, Protocol chair		Ph: 336-713-6501; 800-446-2255

Registry Information
Official Title		Induction/Concurrent Chemotherapy and Dose-Escalated Three Dimensional Thoracic Radiation for Patients with Stage III Non Small Cell Lung Cancer: A Randomized Phase II Study
Trial Start Date		2002-03-15
Trial Completion Date		2008-05-20
Registered in ClinicalTrials.gov		NCT00033553
Date Submitted to PDQ		2002-02-21
Information Last Verified		2005-11-11
NCI Grant/Contract Number		U10-CA31946

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