January NCCTG Protocol No: N0927 Opened: September 3, 2009
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1 January RTOG Protocol No: 0915 Protocol Status: NCCTG Protocol No: N0927 Opened: September 3, 2009 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 Patient Population: Medically inoperable, biopsy proven early stage T1, T2 (< 5 cm) NSCLC patients; clinically node negative by PET, with peripherally located tumors (> 2 cm in all directions around the proximal bronchial tree; see Section 3.2.2) Objectives: Primary: The rate of 1-year grade 3 or higher adverse events definitely, probably, or possibly related to treatment (see Section 13.1 for specific adverse events) Secondary: 1-year local control rate; 1-year overall survival and disease-free survival rate; Assessment of FDG PET SUV changes as a measure of treatment response and outcomes; Pulmonary function changes by treatment arm and response; Association between biomarkers and local control and/or grade 2 or higher radiation pneumonitis. Schema: S T R A T I F Y Zubrod Performance Status T Stage 1. T1 2. T2 R A N D O M I Z E Stereotactic Body Radiation Therapy (SBRT) Arm 1: Arm 2: 48 Gy in 4 once-daily consecutive fractions Study Chairs: Radiation Oncology Patients entered through 11/21/10: Gregory Videtic, M.D., CM, FRCPC RTOG Study 55 (Principal Investigator) RTOG 54 Anurag K. Singh, M.D. RTOG NCCTG 1 (Co-Principal Investigator) Joe Y. Chang, M.D., Ph.D. RTOG (Co-Principal Investigator) Kenneth R. Olivier, M.D. NCCTG Steven E. Schild, M.D. NCCTG Medical Physics William Parker, MSc, FCCPM Translational Research Quynh-Thu Le, M.D. RTOG RTOG
2 January Statistician: Rebecca Paulus, B.S. RTOG Research Associate: Jeff Serianni, B.S. RTOG Roseann Bonanni, CCRP RTOG Dosimetrist: Julie McIlvaine, R.T.(T.) RTOG Protocol Associate: Linda Walters-Page, M.A. RTOG I. Summary: This study opened September 3, Targeted accrual is 88 patients. Expected monthly accrual is 2 patients per month. SBRT credentialing is required for all institutions wishing to participate. See Section 5.0 of the protocol for details. As of November 21, 2010, 55 patients have been accrued. This study is accruing more quickly than anticipated; accrual for the last 6 months was at a rate of 7 patients/month. Adverse event data is collected using CTCAE v.4 and is presented in section IV. II. Administrative Information: Table 2.1 Patient Accrual Study sample size 88 Total patients entered through November 21, Average monthly accrual for the study 3.8 Average monthly accrual for the last 6 months 7.0 Projected completion date based on last 6 months April 2011 Table 2.2 Institutional Accrual RTOG Full Members and Affiliates (n=50) UNIV. OF TEXAS-MD ANDERSON CANCER CENTER UNIV. OF TEXAS-MD ANDERSON CANCER CENTER MD ANDERSON CANCER CENTER - ORLANDO THOMAS JEFFERSON UNIV. HOSPITAL 5 PENN STATE UNIV. AND THE MILTON S. 4 HERSHEY MEDICAL CTR POCONO CANCER CENTER 1 UNIV. OF CALIFORNIA SAN FRANCISCO 5 STANFORD UNIV. MEDICAL CENTER 3 ALTA BATES HOSPITAL COMPREHENSIVE 1 CANCER CENTER UNIV. OF CALIFORNIA SAN FRANCISCO 1 ARIZONA ONCOLOGY SERVICES FOUNDATION 4 WAKE FOREST UNIV. BAPTIST MEDICAL 4 CENTER HENRY FORD HOSPITAL CLEVELAND CLINIC FOUNDATION 3 RADIOLOGICAL ASSOCIATES OF SACRAMENTO 3 MERCY SAN JUAN RADIATION ONCOLOGY 3 CENTER LONDON REGIONAL CANCER CENTRE 2 GRAND RIVER REGIONAL CANCER 2 CENTRE AT GRAND RIVER HOSPITAL ROSWELL PARK CANCER INSTITUTE 2 UNIV. OF MARYLAND MEDICAL SYSTEMS 2 UNIV. OF KENTUCKY HOSPITAL 2 WASHINGTON UNIV. 2 MEDICAL COLLEGE OF WISCONSIN 1 UNIV. OF COLORADO DENVER 1 UNIV. OF ROCHESTER 1 UNIV. OF TEXAS SOUTHWESTERN MEDICAL SCHOOL 4
3 January RTOG CCOP Members and Components (n=4) NORTHERN INDIANA CANCER RESEARCH 2 CONSORTIUM CCOP MEMORIAL HOSPITAL 2 COLUMBIA RIVER CCOP 1 PROVIDENCE PORTLAND MEDICAL 1 CENTER KANSAS CITY CCOP 1 MAYO CLINIC ARIZONA 1 NCCTG (n=1) Table 2.3 Case Status 48 Gy in 4 fractions Total Total patients entered Ineligible/no protocol RX Eligible/pending With on-study information With adverse event information Table 2.4 Cases Excluded Reason (n=1) 48 Gy in 4 fractions (n=1) Evaluation by experienced thoracic cancer clinician > 8 weeks prior to registration 0 ( 0.0%) 1 (100.0%) No protocol treatment 1 (100.0%) 0 ( 0.0%) Table 2.5 Cases with Pending Eligibility Reason 34 Gy in 1 fraction (n=2) 48 Gy in 4 fractions (n=1) Verifying baseline CT done > 8 weeks prior to registration 1 ( 50.0%) 0 ( 0.0%) Verifying baseline PET done > 8 weeks prior to registration 1 ( 50.0%) 0 ( 0.0%) Verifying baseline PFTs done > 8 weeks prior to registration 0 ( 0.0%) 1 (100.0%)
4 January III. Pretreatment Characteristics: Table 3.1 Pretreatment Characteristics 34 Gy in 1 fraction (n=17) 48 Gy in 4 fractions (n=16) Age (years) Median Min - Max Q1 - Q Gender Male 4 ( 23.5%) 8 ( 50.0%) Female 13 ( 76.5%) 8 ( 50.0%) Race Asian 1 ( 5.9%) 0 ( 0.0%) Black or African American 3 ( 17.6%) 3 ( 18.8%) White 13 ( 76.5%) 12 ( 75.0%) Unknown 0 ( 0.0%) 1 ( 6.3%) Ethnicity Hispanic or Latino 1 ( 5.9%) 0 ( 0.0%) Not Hispanic or Latino 15 ( 88.2%) 14 ( 87.5%) Unknown 1 ( 5.9%) 2 ( 12.5%) Zubrod Performance Status* 0 4 ( 23.5%) 4 ( 25.0%) 1 11 ( 64.7%) 7 ( 43.8%) 2 2 ( 11.8%) 5 ( 31.3%) RT Technique No IMRT 10 ( 58.8%) 10 ( 62.5%) IMRT 7 ( 41.2%) 6 ( 37.5%) Histology Squamous cell carcinoma 2 ( 11.8%) 8 ( 50.0%) Adenocarcinoma 12 ( 70.6%) 6 ( 37.5%) Non-small cell lung cancer NOS 3 ( 17.6%) 2 ( 12.5%) T Stage* T1 16 ( 94.1%) 13 ( 81.3%) T2 1 ( 5.9%) 3 ( 18.8%) *Stratification factor. Ql = first quartile; Q3 = third quartile.
5 January Table 3.2 Gender/Ethnicity/Race Distributions Sex/Gender Ethnic Category Females Males Total Hispanic or Latino Not Hispanic or Latino Unknown (Individuals not reporting ethnicity) Ethnic Category: Total of All Subjects Racial Category Asian Black or African American White Unknown or not reported Racial Category: Total of All Subjects
6 January IV: Adverse Events: Table 4.1 Summary of Worst Adverse Event per Patient Relationship to Treatment Adverse Event Grade 34 Gy in 1 fraction (n=11) 48 Gy in 4 fractions (n=9) Definitely, Probably, or Possibly Worst non-hematologic 1 2 ( 18.2%) 2 ( 22.2%) 2 1 ( 9.1%) 0 ( 0.0%) 3 0 ( 0.0%) 0 ( 0.0%) 4 0 ( 0.0%) 0 ( 0.0%) 5 0 ( 0.0%) 0 ( 0.0%) Worst overall 1 2 ( 18.2%) 2 ( 22.2%) 2 1 ( 9.1%) 0 ( 0.0%) 3 0 ( 0.0%) 0 ( 0.0%) 4 0 ( 0.0%) 0 ( 0.0%) 5 0 ( 0.0%) 0 ( 0.0%) Any Worst non-hematologic 1 2 ( 18.2%) 2 ( 22.2%) 2 2 ( 18.2%) 1 ( 11.1%) 3 0 ( 0.0%) 0 ( 0.0%) 4 0 ( 0.0%) 0 ( 0.0%) 5 1 ( 9.1%) 0 ( 0.0%) Worst overall 1 2 ( 18.2%) 2 ( 22.2%) 2 2 ( 18.2%) 1 ( 11.1%) 3 0 ( 0.0%) 0 ( 0.0%) 4 0 ( 0.0%) 0 ( 0.0%) 5 1 ( 9.1%) 0 ( 0.0%) Includes adverse events where relationship to protocol treatment is missing.
7 January Table 4.2 Number of Patients with an Adverse Event by Category, Term, and Grade Definitely, Probably, or Possibly Related to Protocol Treatment System Organ Class (n=11) Grade 48 Gy in 4 fractions (n=9) Grade Term INJURY, POISONING AND PROCEDURAL COMPLICATIONS Radiation recall reaction (dermatologic) INVESTIGATIONS Carbon monoxide diffusing capacity decreased Forced expiratory volume decreased MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Chest wall pain RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Cough Dyspnea Pleural effusion Pleuritic pain Pneumonitis Pulmonary fibrosis Includes adverse events where relationship to protocol treatment is missing. Adverse events were graded with CTCAE version 4. Table 4.3 Number of Patients with an Adverse Event by Category and Grade Any Relationship to Protocol Treatment (n=11) Grade 48 Gy in 4 fractions (n=9) Grade System Organ Class Blood and lymphatic system disorders General disorders and administration site conditions Infections and infestations Injury, poisoning and procedural complications Investigations Musculoskeletal and connective tissue disorders Respiratory, thoracic and mediastinal disorders Includes adverse events where relationship to protocol treatment is missing. Adverse events were graded with CTCAE version 4.
8 January Table 4.4 Grade 5 Adverse Events Assigned Treatment Case Number System Organ Class Term Relationship to Treatment Days from Start of Treatment Days from End of Treatment 3 General disorders and administration site conditions Death NOS Unrelated Adverse events were graded with CTCAE version 4.0.
9 January V. Protocol Treatment Reviews: Table 5.1 Status of Protocol Treatment Reviews 34 Gy in 1 fraction (n=26) 48 Gy in 4 fractions (n=28) Radiation therapy Contour and dose reviewed 11 ( 42.3%) 14 ( 50.0%) Contour reviewed 0 ( 0.0%) 1 ( 3.6%) Not reviewed 15 ( 57.7%) 13 ( 46.4%) Table 5.2 Radiotherapy Review Tumor Volume Tumor Volume Dose Volume Analysis Score Tumor Volume Total Per protocol 8 (72.7%) 3 (27.3%) 0 (0.0%) 11 (100.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Total 8 (72.7%) 3 (27.3%) 0 (0.0%) 11 (100.0%) 48 Gy in 4 fractions Tumor Volume Dose Volume Analysis Score Tumor Volume deviation Not reviewed Total Per protocol 6 (40.0%) 7 (46.7%) 0 (0.0%) 1 (6.7%) 14 (93.3%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) deviation 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Not reviewed 1 (6.7%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (6.7%) Total 7 (46.7%) 7 (46.7%) 0 (0.0%) 1 (6.7%) 15 (100.0%)
10 January Table 5.3 Radiotherapy Review Organs at Risk Organs at Risk Dose Volume Analysis Score Organs at Risk Total Per protocol 6 (54.5%) 1 (9.1%) 0 (0.0%) 7 (63.6%) 4 (36.4%) 0 (0.0%) 0 (0.0%) 4 (36.4%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Total 10 (90.9%) 1 (9.1%) 0 (0.0%) 11 (100.0%) 48 Gy in 4 fractions Organs at Risk Dose Volume Analysis Score Organs at Risk deviation Not reviewed Total Per protocol 7 (47%) 1 (7%) 0 (0%) 0 (0%) 8 (53%) 4 (27%) 0 (0%) 0 (0%) 0 (0%) 4 (27%) deviation 1 (7%) 0 (0%) 0 (0%) 1 (7%) 2 (13%) Not reviewed 1 (7%) 0 (0%) 0 (0%) 0 (0%) 1 (7%) Total 13 (87%) 1 (7%) 0 (0%) 1 (7%) 15 (100%) Table 5.4 Radiotherapy Review Tumor Volume by Organs at Risk Organs at Risk Dose Volume Analysis Score Tumor Volume Total Per protocol 7 (63.6%) 4 (36.4%) 0 (0.0%) 11 (100.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Total 7 (63.6%) 4 (36.4%) 0 (0.0%) 11 (100.0%) 48 Gy in 4 fractions Organs at Risk Dose Volume Analysis Score Tumor Volume deviation Not reviewed Total Per protocol 8 (53%) 4 (27%) 2 (13%) 0 (0%) 14 (93%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) deviation 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) Not reviewed 0 (0%) 0 (0%) 0 (0%) 1 (7%) 1 (7%) Total 8 (53%) 4 (27%) 2 (13%) 1 (7%) 15 (100%)
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