Trial record 1 of 1 for:    RTOG 0813
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Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NRG Oncology Foundation, Inc.
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00750269
First received: September 9, 2008
Last updated: July 21, 2014
Last verified: July 2014

September 9, 2008
July 21, 2014
February 2009
December 2014   (final data collection date for primary outcome 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. ] [ Designated as safety issue: Yes ]
  • To estimate the primary tumor control rate at the maximum tolerated dose (MTD) [ Time Frame: From start of SBRT until 2 years. ] [ Designated as safety issue: No ]
  • Maximum tolerated dose of stereotactic body radiotherapy (SBRT) as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Dose-limiting toxicity (DLT) of ≥ grade 3 as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00750269 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Toxicity (other than DLT) of ≥ grade 3 as assessed by NCI CTCAE v4.0 [ Time Frame: From start of SBRT until 1 year. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 2-year local control rate [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Time to local progression [ Designated as safety issue: No ]
  • Time to regional nodal progression [ Designated as safety issue: No ]
  • Time to distant metastases [ Designated as safety issue: No ]
  • Toxicity (other than DLT) of ≥ grade 3 as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Late toxicity (i.e., occurs > 1 year after the start of SBRT) of ≥ grade 3 as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Radiation: stereotactic body radiation therapy (SBRT)
  • Experimental: Level 1: 8 Gy x 5 fractions
    stereotactic body radiation therapy (SBRT) of 8 Gy x 5 fractions
    Intervention: Radiation: stereotactic body radiation therapy (SBRT)
  • Experimental: Level 2: 8.5 Gy x 5 fractions
    stereotactic body radiation therapy (SBRT) of 8.5 Gy x 5 fractions
    Intervention: Radiation: stereotactic body radiation therapy (SBRT)
  • Experimental: Level 3: 9 Gy x 5 fractions
    stereotactic body radiation therapy (SBRT) of 9 Gy x 5 fractions
    Intervention: Radiation: stereotactic body radiation therapy (SBRT)
  • Experimental: Level 4: 9.5 Gy x 5 fractions
    stereotactic body radiation therapy (SBRT) of 9.5 Gy x 5 fractions
    Intervention: Radiation: stereotactic body radiation therapy (SBRT)
  • Experimental: Level 5: 10 Gy x 5 fractions
    stereotactic body radiation therapy (SBRT) of 10 Gy x 5 fractions
    Intervention: Radiation: stereotactic body radiation therapy (SBRT)
  • Experimental: Level 6: 10.5 Gy x 5 fractions
    stereotactic body radiation therapy (SBRT) of 10.5 Gy x 5 fractions
    Intervention: Radiation: stereotactic body radiation therapy (SBRT)
  • Experimental: Level 7: 11 Gy x 5 fractions
    stereotactic body radiation therapy (SBRT) of 11 Gy x 5 fractions
    Intervention: Radiation: stereotactic body radiation therapy (SBRT)
  • Experimental: Level 8: 11.5 Gy x 5 fractions
    stereotactic body radiation therapy (SBRT) of 11.5 Gy x 5 fractions
    Intervention: Radiation: stereotactic body radiation therapy (SBRT)
  • Experimental: Level 9: 12 Gy x 5 fractions
    stereotactic body radiation therapy (SBRT) of 12 Gy x 5 fractions
    Intervention: Radiation: stereotactic body radiation therapy (SBRT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
110
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00750269
RTOG-0813, CDR0000613524, NCI-2009-01095
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
  • National Cancer Institute (NCI)
  • NRG Oncology Foundation, Inc.
Principal Investigator: Andrea Bezjak, MD, MSC, FRCPC Princess Margaret Hospital, Canada
Study Chair: Jeffrey Bradley, MD Mallinckrodt Institute of Radiology at Washington University Medical Center
Study Chair: Laurie E. Gaspar, MD, MBA University of Colorado, Denver
Radiation Therapy Oncology Group
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP