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

NCT00087438 | Completed Phase 2 Results DMC

• 2 other identifiers: RTOG-0236CDR0000371578
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Local Control at 2 Years

  Local control is defined as absence of local failure, which is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Local control time is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local failure (censored). Rates are estimated using the Kaplan-Meier method.

  From the start of treatment to 2 years

Secondary Outcomes (6)

• Proportion of Subjects With Specified Adverse Events

  From randomization to last follow-up. Analysis occurred after all patients had been on study for at least 2 years. Maximum follow-up at time of analysis was 4.2 years.

• Rate of Local Recurrence at 2 Years

  From the start of treatment to 2 years

• Rate of Regional Recurrence at 2 Years

  From the start of treatment to 2 years

• Rate of Disseminated Recurrence at 2 Years

  From the start of treatment to 2 years

• Rate of Disease-free Survival at 2 Years

  From the start of treatment to 2 years

Study Arms (1)

Stereotactic body radiation therapy (SBRT)

EXPERIMENTAL

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

Radiation: stereotactic body radiation therapy

Interventions

stereotactic body radiation therapy RADIATION

Stereotactic body radiation therapy (SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * The following primary cancer subtypes are eligible: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

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

Rochester, New York, 14642, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Publications (5)

• 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.

  PMID: 19695451 BACKGROUND

• 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.

  PMID: 16982540 BACKGROUND

• 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.

  PMID: 20233825 RESULT

• 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.

  PMID: 19251095 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Wendy Seiferheld
• Organization: Radition Therapy Oncology Group (RTOG)

wseiferheld@gmail.com

Study Officials

• Robert D. Timmerman, MD

  Simmons Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: May 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2016
• Last Updated: January 16, 2019
• Results First Posted: April 7, 2014

Record last verified: 2018-12

Locations

US (2)