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

NCT00843726 | Completed Phase 2 Results DMC

• 1 other identifier: I 124407
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with 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

Outcome Measures

Primary Outcomes (3)

• Incidence of AE Grade 3 or Higher Toxicity

  Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse.

  1year

• Overall Survival

  Median overall survival

  5 years

• Correlation Between Blood and Serum Markers and Survival and Toxicity

  4 years

Study Arms (2)

Arm I

EXPERIMENTAL

Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).

Radiation: Arm 1 stereotactic body radiation therapy

Arm II

EXPERIMENTAL

Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.

Radiation: Arm II stereotactic body radiation therapy

Interventions

Arm 1 stereotactic body radiation therapy RADIATION

Patients undergo 1 high-dose fraction

Arm I

Arm II stereotactic body radiation therapy RADIATION

Patients undergo 3 high-dose fractions

Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed non-small cell lung cancer
• T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded)
• Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection
• Age \>= 18

You may not qualify if:

• Prior thoracic radiation therapy
• T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement
• Node positive or metastatic disease
• Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree.
• No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
• Pregnant or unwilling to use adequate contraception

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (3)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

adrienne.groman@roswellpark.org

7168451300

Study Officials

• Anurag K. Singh, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: September 12, 2008
• Primary Completion: May 6, 2020
• Study Completion: May 6, 2020
• Last Updated: June 15, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-05

Locations

US (3)