Overview

This trial is active, not recruiting.

Condition lung cancer
Treatment stereotactic body radiation therapy (sbrt)
Phase phase 1/phase 2
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date February 2009
End date September 2014
Trial size 110 participants
Trial identifier NCT00750269, CDR0000613524, NCI-2009-01095, NCT01317056, RTOG-0813

Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I non-small cell lung cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
stereotactic body radiation therapy (SBRT) of 8 Gy x 5 fractions
stereotactic body radiation therapy (sbrt)
(Experimental)
stereotactic body radiation therapy (SBRT) of 8.5 Gy x 5 fractions
stereotactic body radiation therapy (sbrt)
(Experimental)
stereotactic body radiation therapy (SBRT) of 9 Gy x 5 fractions
stereotactic body radiation therapy (sbrt)
(Experimental)
stereotactic body radiation therapy (SBRT) of 9.5 Gy x 5 fractions
stereotactic body radiation therapy (sbrt)
(Experimental)
stereotactic body radiation therapy (SBRT) of 10 Gy x 5 fractions
stereotactic body radiation therapy (sbrt)
(Experimental)
stereotactic body radiation therapy (SBRT) of 10.5 Gy x 5 fractions
stereotactic body radiation therapy (sbrt)
(Experimental)
stereotactic body radiation therapy (SBRT) of 11 Gy x 5 fractions
stereotactic body radiation therapy (sbrt)
(Experimental)
stereotactic body radiation therapy (SBRT) of 11.5 Gy x 5 fractions
stereotactic body radiation therapy (sbrt)
(Experimental)
stereotactic body radiation therapy (SBRT) of 12 Gy x 5 fractions
stereotactic body radiation therapy (sbrt)

Primary Outcomes

Measure
Maximum tolerated dose of stereotactic body radiotherapy (SBRT) as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 (Phase I)
time frame: From start of SBRT until 1 year.
To estimate the primary tumor control rate at the maximum tolerated dose (MTD)
time frame: From start of SBRT until 2 years.

Secondary Outcomes

Measure
Progression-free survival
time frame: From randomization to date of death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.
Overall survival
time frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.
Time to local progression
time frame: From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.
Time to regional nodal progression
time frame: From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.
Time to distant metastases
time frame: From randomization to date of death, distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.
Toxicity (other than DLT) of ≥ grade 3 as assessed by NCI CTCAE v4.0
time frame: From start of SBRT until 1 year.
Late toxicity (i.e., occurs > 1 year after the start of SBRT) of ≥ grade 3 as assessed by NCI CTCAE v4.0
time frame: From start of treatment to end of follow-up.

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) - Stage T1-2, N0, M0 disease - Tumor size ≤ 5 cm - Tumor must be within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (i.e., carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right, and left lower lobe bronchi) OR immediately adjacent to the mediastinal or pericardial pleura (PTV touching the pleura) - Hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or mediastinal uptake on PET scan are considered N0 - Mediastinal lymph node sampling by any technique is allowed but not required - Patients with > 1 cm hilar or mediastinal lymph nodes on CT scan or abnormal PET scan (including suspicious but nondiagnostic uptake) are eligible provided directed tissue biopsies of all abnormally identified areas are negative for cancer - Tumor deemed technically resectable, in the opinion of an experienced thoracic cancer surgeon, with a reasonable possibility of obtaining a gross total resection with negative margins, defined as a potentially curative resection (PCR) - Patient deemed "medically inoperable" due to severe underlying physiological medical problems that would prohibit a PCR, including any of the following: - Baseline forced expiratory volume at one second (FEV1) < 40% predicted - Postoperative FEV1 < 30% predicted - Severely reduced diffusion capacity - Baseline hypoxemia and/or hypercapnia - Exercise oxygen consumption < 50% predicted - Severe pulmonary hypertension - Diabetes mellitus with severe end-stage organ damage - Severe cerebral, cardiac, or peripheral vascular disease - Severe chronic heart disease - Measurable disease as documented by CT scan or whole-body PET scan within the past 8 weeks - Patients with lesions that cannot be visualized by CT scan are not eligible - Pleural effusion allowed provided it is deemed too small to tap under CT guidance and is not evident on chest x-ray - Pleural effusion that appears on chest x-ray is allowed only after thoracotomy or other invasive procedure PATIENT CHARACTERISTICS: - Zubrod performance status 0-2 - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for ≥ 60 days after completion of study therapy - No other invasive malignancy within the past 2 years except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix - Prior lung cancer allowed provided the patient has been disease-free for ≥ 2 years PRIOR CONCURRENT THERAPY: - No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields - No prior chemotherapy for the study cancer - No other concurrent local therapy (including standard-fractionated radiotherapy and/or surgery) or systemic therapy (including standard chemotherapy or biologic targeted agents) specifically intended as treatment for study cancer - Local or systemic therapy at the time of disease progression allowed

Additional Information

Official title Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients
Principal investigator Andrea Bezjak, MD, MSC, FRCPC
Description OBJECTIVES: Primary - To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) in medically inoperable patients with centrally located stage I non-small cell lung cancer. (Phase I) - To determine the efficacy of SBRT when administered at the MTD in these patients. (Phase I) - To estimate the local control rate of SBRT at the MTD in these patients. (Phase II) Secondary - To estimate the rates of adverse events (other than dose-limiting toxicity) of ≥ grade 3 that is possibly, probably, or definitely related to treatment and that occurs within 1 year after the start of SBRT in these patients. - To estimate the rates of late adverse events (i.e., occurs > 1 year after the start of SBRT) in these patients. - To estimate the local control and progression-free and overall survival rates in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks (total of 5 fractions) in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.