Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer

NCT ID: NCT00087438

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2016-12-31

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic body radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with inoperable stage I or stage II non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

• Determine whether treatment with stereotactic body radiotherapy results in acceptable local control (i.e., ≥ 80%) in patients with medically inoperable stage I or II non-small cell lung cancer.

Secondary

• Determine treatment-related toxicity in patients treated with this therapy.
• Determine disease-free survival, overall survival, and patterns of failure in patients treated with this therapy.

OUTLINE: This is a multicenter study.

Patients receive 3 fractions of stereotactic body radiotherapy over 8-14 days in the absence of disease progression or unacceptable toxicity.

Patients are followed up at 6 and 12 weeks, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 26 months.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic body radiation therapy (SBRT)

20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy

Group Type: EXPERIMENTAL

stereotactic body radiation therapy

Intervention Type: RADIATION

Interventions

stereotactic body radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Squamous cell carcinoma
• Adenocarcinoma
• Large cell carcinoma
• Bronchoalveolar cell carcinoma
• Non-small cell carcinoma not otherwise specified
• Stage I or II disease based on 1 of the following tumor node metastasis (TNM) stage criteria:

• T1, N0, M0
• T2 (≤ 5 cm), N0, M0
• T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only)
• No primary tumor of any T-stage within or touching the zone of the proximal bronchial tree* NOTE: *Defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi)
• No primary T3 tumors involving the central chest (≤ 2 cm toward carina invasion) or structures of the mediastinum
• Any hilar or mediastinal lymph nodes > 1 cm on CT scan OR demonstrating suspicious uptake on positron-emission tomography scan must be biopsied and confirmed negative for NSCLC
• The primary tumor must be deemed technically resectable with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection (PCR))
• Deemed medically inoperable based on pulmonary function for surgical resection of NSCLC secondary to an underlying physiological problem, including any of the following medical conditions*:

• Baseline forced expiratory volume (FEV)_1< 40% of predicted
• Postoperative predicted FEV_1 < 30% of predicted
• Severely reduced diffusion capacity
• Baseline hypoxemia and/or hypercapnia
• Exercise oxygen consumption < 50% of predicted
• Severe pulmonary hypertension
• Diabetes mellitus with severe end organ damage
• Severe cerebral, cardiac, or peripheral vascular disease
• Severe chronic heart disease NOTE: *Patients who refuse a PCR due to preference, ideology, emotional or psychological issues, mental illness, or inability to give informed consent are not eligible
• No evidence of regional or distant metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• See Disease Characteristics
• No active pericardial infection

Pulmonary

• See Disease Characteristics
• No active pulmonary infection

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active systemic infection
• No other concurrent illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent biologic therapy
• No concurrent vaccine therapy

Chemotherapy

• No concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior lung or mediastinal radiotherapy
• No concurrent standard fractionated radiotherapy
• No concurrent intensity modulated radiotherapy
• No concurrent cobalt-60 or charged particle beams (including electrons, protons, or heavier ions)

Surgery

• See Disease Characteristics
• No concurrent surgery

Other

• No other concurrent antineoplastic therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert D. Timmerman, MD

Role: PRINCIPAL_INVESTIGATOR

Simmons Cancer Center

Locations

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Countries

United States

References

Hurkmans CW, Cuijpers JP, Lagerwaard FJ, Widder J, van der Heide UA, Schuring D, Senan S. Dosimetric evaluation of heterogeneity corrections for RTOG 0236: stereotactic body radiotherapy of inoperable Stage I-II non-small-cell lung cancer. In reply to Dr. Xiao et al. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):318; author reply 318. doi: 10.1016/j.ijrobp.2009.05.050. No abstract available.

Reference Type: BACKGROUND

PMID: 19695451 (View on PubMed)

Timmerman R, Galvin J, Michalski J, Straube W, Ibbott G, Martin E, Abdulrahman R, Swann S, Fowler J, Choy H. Accreditation and quality assurance for Radiation Therapy Oncology Group: Multicenter clinical trials using Stereotactic Body Radiation Therapy in lung cancer. Acta Oncol. 2006;45(7):779-86. doi: 10.1080/02841860600902213.

Reference Type: BACKGROUND

PMID: 16982540 (View on PubMed)

Timmerman R, Paulus R, Galvin J, Michalski J, Straube W, Bradley J, Fakiris A, Bezjak A, Videtic G, Johnstone D, Fowler J, Gore E, Choy H. Stereotactic body radiation therapy for inoperable early stage lung cancer. JAMA. 2010 Mar 17;303(11):1070-6. doi: 10.1001/jama.2010.261.

Reference Type: RESULT

PMID: 20233825 (View on PubMed)

Xiao Y, Papiez L, Paulus R, Timmerman R, Straube WL, Bosch WR, Michalski J, Galvin JM. Dosimetric evaluation of heterogeneity corrections for RTOG 0236: stereotactic body radiotherapy of inoperable stage I-II non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2009 Mar 15;73(4):1235-42. doi: 10.1016/j.ijrobp.2008.11.019.

Reference Type: RESULT

PMID: 19251095 (View on PubMed)

Timmerman RD, Paulus R, Galvin J, et al.: Toxicity analysis of RTOG 0236 using stereotactic body radiation therapy to treat medically inoperable early stage lung cancer patients. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-151, S86, 2007.

Reference Type: RESULT

Other Identifiers

CDR0000371578

Identifier Type: -

Identifier Source: secondary_id

RTOG-0236

Identifier Type: -

Identifier Source: org_study_id