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

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ClinicalTrials.gov Identifier: NCT00960999
Recruitment Status : Active, not recruiting
First Posted : August 18, 2009
Results First Posted : November 4, 2014
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which regimen of stereotactic body 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 non-small cell lung cancer.


Condition or disease Intervention/treatment Phase
Lung Cancer Radiation: Single-fraction stereotactic body radiation therapy (SBRT) Radiation: Multiple-fraction stereotactic body radiation therapy (SBRT) Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • To determine the 1-year rate of ≥ grade 3 adverse events that are definitely, probably, or possibly related to treatment with single fraction vs multiple fraction stereotactic body radiotherapy in medically inoperable patients with stage I peripheral non-small cell lung cancer.

Secondary

  • To estimate the 1-year primary tumor control rate in these patients.
  • To estimate the 1-year overall survival and disease-free survival rate of these patients.
  • To assess FDG-PET (fluorodeoxyglucose) standardized uptake value changes as a measure of treatment response and outcomes.
  • To determine pulmonary function changes by treatment arm and response.
  • To determine the association between biomarkers and primary tumor control and/or ≥ grade 2 radiation pneumonitis.

OUTLINE: This is a multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1 vs 2) and T stage (T1 vs T2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (single fraction): Patients undergo one stereotactic body radiotherapy (SBRT) treatment to the target lesion.
  • Arm II (multiple fractions): Patients undergo SBRT to the target lesion once daily for 4 days.

Blood and tumor tissue samples may be collected for further analysis.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer
Actual Study Start Date : November 2009
Primary Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Single-fraction SBRT (34 Gy)
Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
Radiation: Single-fraction stereotactic body radiation therapy (SBRT)
34 Gy in 1 fraction to the prescription line at the edge of the planning target volume (PTV). The maximum dose must exist within the PTV, and the prescription isodose surface must be ≥ 60% and < 90% of the maximum dose. 99% of the PTV must receive a minimum of 90% of the prescription dose. The maximum dose to any point ≥ 2 cm away from the PTV in any direction must be at least < 50% of the prescription dose. The percent of the lungs (excluding PTV) receiving 20 Gy or more must be < 10%.
Experimental: Multiple-fraction SBRT (48 Gy)
Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
Radiation: Multiple-fraction stereotactic body radiation therapy (SBRT)
48 Gy in four 12 Gy fractions to the prescription line at the edge of the planning target volume (PTV). Treatments are given on 4 consecutive calendar days, but at least 18 hours apart. The maximum dose must exist within the PTV, and the prescription isodose surface must be ≥ 60% and < 90% of the maximum dose. 99% of the PTV must receive a minimum of 90% of the prescription dose. The maximum dose to any point ≥ 2 cm away from the PTV in any direction must be at least < 50% of the prescription dose. The percent of the lungs (excluding PTV) receiving 20 Gy or more must be < 10%.


Outcome Measures

Primary Outcome Measures :
  1. Counts of ≥ Grade 3 Adverse Events (AE) Graded by CTCAE v4 (Common Terminology Criteria for Adverse Events) That Are Definitely, Probably, or Possibly Related to Treatment (DPPRT) [ Time Frame: From start of treatment to 1 year ]
    Number of patients with ≥ grade 3 AE occurring within 1 year of treatment (TRT) start and reported as DPPRT among this subset of CTCAE v4: pericardial effusion, pericarditis, restrictive cardiomyopathy, dysphagia, esophagitis, esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage, rib fracture, brachial plexopathy, recurrent laryngeal nerve palsy, myelitis, atelectasis, bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, bronchial/pulmonary/bronchopleural/tracheal fistula, hypoxia, bronchial/tracheal obstruction, pleural effusion, pneumonitis, pulmonary fibrosis, skin ulceration (thorax only), FEV1 (Forced Expiratory Volume) or FVC (forced vital capacity) decline, or grade 5 related to TRT. Each arm is considered independently. For each arm, >=5 of 38 analyzable subjects experiencing a grade ≥ 3 AE during the 1st year following TRT start would determine the respective TRT excessively toxic. For each arm this design provides 88% power with a 0.10 type I error rate.


Secondary Outcome Measures :
  1. 1-year Primary Tumor Control Rate [ Time Frame: From start of treatment to 1 year ]
  2. 1-year Overall Survival and Disease-free Survival Rate [ Time Frame: From start of treatment to 1 year ]
  3. Distribution of FDG-PET (Fluorodeoxyglucose) Standardized Uptake Value Changes as a Potential Measure of Treatment Response and Outcomes [ Time Frame: From start of treatment to date of failure (local, regional or distant), death or last follow-up. ]
  4. Distribution of Pulmonary Function Changes by Treatment Arm and Response [ Time Frame: From start of treatment to end of follow-up. ]
  5. Association Between Biomarkers, Primary Tumor Control Rate, and ≥ Grade 2 Radiation Pneumonitis [ Time Frame: From start of treatment to 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed primary non-small cell lung cancer, including one of the following subtypes:

    • Squamous cell carcinoma
    • Adenocarcinoma
    • Large cell carcinoma
    • Large cell neuroendocrine carcinoma
    • Non-small cell carcinoma not otherwise specified
  • Stage T1-2, N0, M0 disease

    • Tumor size ≤ 5 cm
    • Hilar or mediastinal lymph nodes ≤ 1 cm with no abnormal hilar or mediastinal uptake on PET scan are considered N0

      • Patients with hilar or mediastinal lymph nodes > 1 cm 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
    • No regional or distant metastases
  • Peripherally located tumor

    • No primary tumor 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 (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)
    • No involvement of the central pleura and/or structures of the mediastinum
  • Resectable disease

    • Patient may have declined surgery after consulting with a thoracic surgeon
  • Patient deemed "medically inoperable", in the opinion of an experienced thoracic cancer clinician (thoracic surgeon, medical oncologist, radiation oncologist, or pulmonologist), due to a severe underlying physiological medical problem that would preclude surgery, 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

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,800/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No synchronous primary malignancy or other malignancy within the past 2 years except for any of the following:

    • Invasive malignancy that was definitively treated and patient remains disease free for > 3 years with a life expectancy of > 3 years
    • Carcinoma in situ
    • Early stage skin cancer that was definitively treated
  • No active systemic, pulmonary, or pericardial infection

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy to the lung or mediastinum
  • No prior chemotherapy for this lung or mediastinal tumor

    • Prior chemotherapy for another invasive malignancy allowed provided it was definitively treated and patient remains disease free for > 3 years
  • No prior surgery for this lung or mediastinal tumor
  • No other concurrent antineoplastic therapy, including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and/or surgery
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960999


  Show 38 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Investigators
Study Chair: Gregory Videtic, MD The Cleveland Clinic
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00960999     History of Changes
Other Study ID Numbers: RTOG 0915
CDR0000652101
First Posted: August 18, 2009    Key Record Dates
Results First Posted: November 4, 2014
Last Update Posted: June 14, 2017
Last Verified: May 2017

Keywords provided by Radiation Therapy Oncology Group:
stage I non-small cell lung cancer
squamous cell lung cancer
adenocarcinoma of the lung
large cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms