8 results on '"Darindra D, Gopaul"'
Search Results
2. Five-year patient reported outcomes in NRG Oncology RTOG 0938, evaluating two ultrahypofractionated regimens for prostate cancer
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Himanshu R, Lukka, Snehal, Deshmukh, Deborah W, Bruner, Jean-Paul, Bahary, Colleen A F, Lawton, Jason A, Efstathiou, Rajat J, Kudchadker, Lee E, Ponsky, Samantha A, Seaward, Ian S, Dayes, Darindra D, Gopaul, Jeff M, Michalski, Guila, Delouya, Irving D, Kaplan, Eric M, Horwitz, Mack, Roach, Felix Y, Feng, Stephanie L, Pugh, Howard M, Sandler, and Lisa A, Kachnic
- Abstract
There is considerable interest in very short (ultrahypofractionated) radiation therapy regimens to treat prostate cancer based on potential radiobiological advantages, patient convenience, and resource allocation benefits. Our objective is to demonstrate that detectable changes in health-related quality of life measured by the bowel and urinary domains of the Expanded Prostate Cancer Index Composite (EPIC-50) were not substantially worse than baseline scores.xxxx is a nonblinded randomized phase 2 study of National Comprehensive Cancer Network low-risk prostate cancer in which each arm is compared with a historical control. Patients were randomized to 5 fractions (7.25Gy in 2 week and a day - twice a week) or 12 fractions (4.3Gy in 2.5 weeks- five times a week). Secondary objectives assessed patient-reported toxicity at 5 years using the Expanded Prostate cancer Index Composite (EPIC). Chi-square tests were used to assess the proportion of patients with a deterioration from baseline of5 points for bowel,2 points for urinary, and11 points for sexual score, RESULTS: The study enrolled 127 patients to 5 fractions (121 eligible) and 128 patients to 12 fractions (125 eligible). Median follow-up for all patients at the time of analysis was 5.38 years. The 5-year frequency for5 point change in bowel score were 38.4% (P=0.27) and 23.4% (= 0.98) for 5 and 12 fractions, respectively. The 5-year frequencies for2 point change in urinary score were 46.6% (P=0.15) and 36.4% (P=0.70) for 5 and 12 fractions, respectively. For 5 fractions, 49.3% (P=0.007) of patients had a drop in 5-year EPIC-50 sexual score of ≥11 points; for 12 fractions, 54% (P0.001) of patients had a drop in 5-year EPIC-50 sexual score of ≥11 points. Disease-free survival at 5 years is 89.6% (95% confidence interval:84.0-95.2) in the 5-fraction arm and 92.3% (95% confidence interval: 87.4- 97.1) in the 12-fraction arm. There was no late grade 4 or 5 treatment-related urinary or bowel toxicity.This study confirms that, based on long-term changes in bowel and urinary domains and toxicity, the 5- and 12-fraction regimens are well tolerated. These ultrahypofractionated approaches need to be compared with current standard radiation therapy regimens.
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- 2022
3. Patient Reported Outcomes in NRG Oncology RTOG 0938, Evaluating Two Ultrahypofractionated Regimens for Prostate Cancer
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Deborah Watkins Bruner, Jeff M. Michalski, Jason A. Efstathiou, Jean Paul Bahary, Mack Roach, Guila Delouya, Rajat J. Kudchadker, Eric M. Horwitz, Lisa A. Kachnic, Colleen A. Lawton, Stephanie L. Pugh, Howard M. Sandler, Ian S. Dayes, Darindra D. Gopaul, Lee Ponsky, Wayne H. Pinover, Samantha A. Seaward, David C. Beyer, H. Lukka, Irving D. Kaplan, and John Amanie
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Oncology ,Male ,Organs at Risk ,Cancer Research ,Aging ,medicine.medical_treatment ,Phases of clinical research ,030218 nuclear medicine & medical imaging ,law.invention ,Prostate cancer ,0302 clinical medicine ,Quality of life ,Randomized controlled trial ,7.1 Individual care needs ,law ,Cancer ,Radiation ,Prostate Cancer ,Femur Head ,Middle Aged ,Other Physical Sciences ,030220 oncology & carcinogenesis ,Radiation Dose Hypofractionation ,Urologic Diseases ,medicine.medical_specialty ,Urinary system ,Urinary Bladder ,Clinical Trials and Supportive Activities ,Clinical Sciences ,Oncology and Carcinogenesis ,Article ,Disease-Free Survival ,03 medical and health sciences ,Urethra ,Clinical Research ,Internal medicine ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Patient Reported Outcome Measures ,Oncology & Carcinogenesis ,Aged ,Radiotherapy ,business.industry ,Rectum ,Prostatic Neoplasms ,medicine.disease ,Radiation therapy ,Clinical trial ,Quality of Life ,Management of diseases and conditions ,business ,Digestive Diseases ,Penis ,Follow-Up Studies - Abstract
PurposeThere is considerable interest in very short (ultrahypofractionated) radiation therapy regimens to treat prostate cancer based on potential radiobiological advantages, patient convenience, and resource allocation benefits. Our objective is to demonstrate that detectable changes in health-related quality of life measured by the bowel and urinary domains of the Expanded Prostate Cancer Index Composite (EPIC-50) were not substantially worse than baseline scores.Methods and materialsNRG Oncology's RTOG 0938 is a nonblinded randomized phase 2 study of National Comprehensive Cancer Network low-risk prostate cancer in which each arm is compared with a historical control. Patients were randomized to 5 fractions (7.25 Gy in 2 weeks) or 12 fractions (4.3 Gy in 2.5 weeks). The co-primary endpoints were the proportion of patients with a change in EPIC-50 bowel score at 1 year (baseline to 1 year) >5 points and in EPIC-50 urinary score >2 points tested with a 1-sample binomial test.ResultsThe study enrolled 127 patients to 5 fractions (121 analyzed) and 128 patients to 12 fractions (125 analyzed). Median follow-up for all patients at the time of analysis was 3.8 years. The 1-year frequency for >5 point change in bowel score were 29.8% (P < .001) and 28.4% (P < .001) for 5 and 12 fractions, respectively. The 1-year frequencies for >2 point change in urinary score were 45.7% (P < .001) and 42.2% (P < .001) for 5 and 12 fractions, respectively. For 5 fractions, 32.9% of patients had a drop in 1-year EPIC-50 sexual score of ≥11 points (P = .34); for 12 fractions, 30.9% of patients had a drop in 1-year EPIC-50 sexual score of ≥ 11 points (P = .20). Disease-free survival at 2 years is 99.2% (95% confidence interval: 97.5-100) in the 5-fraction arm and 97.5% (95% confidence interval: 94.6-100) in the 12-fraction arm. There was no late grade 4 or 5 treatment-related urinary or bowel toxicity.ConclusionsThis study confirms that, based on changes in bowel and urinary domains and toxicity (acute and late), the 5- and 12-fraction regimens are well tolerated. These ultrahypofractionated approaches need to be compared with current standard radiation therapy regimens.
- Published
- 2018
4. Long-term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927): A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer
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Kevin L. Stephans, Sue S. Yom, Robert Timmerman, William Parker, Jeffrey D. Bradley, Ritsuko Komaki, Kenneth R. Olivier, Joe Y. Chang, Puneeth Iyengar, Gregory M.M. Videtic, Chandra P. Belani, Clifford G. Robinson, James J. Urbanic, Hak Choy, Rebecca Paulus, Jorge B. Gomez Suescun, Anurag K. Singh, Munther Ajlouni, Ronald C. McGarry, and Darindra D. Gopaul
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Oncology ,Male ,Cancer Research ,Lung Neoplasms ,Time Factors ,Phases of clinical research ,030218 nuclear medicine & medical imaging ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,Carcinoma, Non-Small-Cell Lung ,80 and over ,Clinical endpoint ,Medicine ,Treatment Failure ,Non-Small-Cell Lung ,Dose Fractionation ,Lung ,Cancer ,Aged, 80 and over ,Radiation ,Lung Cancer ,Middle Aged ,Primary tumor ,Progression-Free Survival ,6.5 Radiotherapy and other non-invasive therapies ,Other Physical Sciences ,030220 oncology & carcinogenesis ,Female ,medicine.medical_specialty ,Clinical Trials and Supportive Activities ,Clinical Sciences ,Oncology and Carcinogenesis ,Radiosurgery ,Article ,03 medical and health sciences ,Clinical Research ,Internal medicine ,Confidence Intervals ,Humans ,Radiology, Nuclear Medicine and imaging ,Oncology & Carcinogenesis ,Progression-free survival ,Lung cancer ,Radiation Injuries ,Aged ,business.industry ,Prevention ,Carcinoma ,Dose fractionation ,Evaluation of treatments and therapeutic interventions ,medicine.disease ,Confidence interval ,Dose Fractionation, Radiation ,business ,Follow-Up Studies - Abstract
PurposeTo present long-term results of RTOG 0915/NCCTG N0927, a randomized lung stereotactic body radiation therapy trial of 34Gy in 1 fraction versus 48Gy in 4 fractions.Methods and materialsThis was a phase 2 multicenter study of patients with medically inoperable non-small cell lung cancer with biopsy-proven peripheral T1 or T2 N0M0 tumors, with 1-year toxicity rates as the primary endpoint and selected failure and survival outcomes as secondary endpoints. The study opened in September 2009 and closed in March 2011. Final data were analyzed through May 17,2018.ResultsEighty-four of 94 patients accrued were eligible for analysis: 39 in arm 1 and 45 in arm 2. Median follow-up time was 4.0years for all patients and 6.0years for those alive at analysis. Rates of grade 3 and higher toxicity were 2.6% in arm 1 and 11.1% in arm 2. Median survival times (in years) for 34Gy and 48Gy were 4.1 versus 4.6, respectively. Five-year outcomes (95% confidence interval) for 34Gy and 48Gy were a primary tumor failure rate of 10.6% (3.3%-23.1%) versus 6.8% (1.7%-16.9%); overall survival of 29.6% (16.2%-44.4%) versus 41.1% (26.6%-55.1%); and progression-free survival of 19.1% (8.5%-33.0%) versus 33.3% (20.2%-47.0%). Distant failure as the sole failure or a component of first failure occurred in 6 patients (37.5%) in the 34Gy arm and in 7 (41.2%) in the 48Gy arm.ConclusionsNo excess in late-appearing toxicity was seen in either arm. Primary tumor control rates at 5years were similar by arm. A median survival time of 4years for each arm suggests similar efficacy, pending any larger studies appropriately powered to detect survival differences.
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- 2018
5. Investigation Into the Feasibility of Having Uniform Compliance Dosimetric Criteria Across Radiation Therapy Treatment Modalities for NRG Oncology/RTOG 0938 by Using Machine Learning
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Ian S. Dayes, T Giaddui, Christine Xue, D. Béliveau-Nadeau, Y. Xiao, Samantha A. Seaward, Qiuwen Wu, Himu Lukka, B.R. Stall, Lulin Yuan, Yutao Gong, J. Yu, Darindra D. Gopaul, Irving D. Kaplan, Wayne H. Pinover, Rajat J. Kudchadker, W. Chen, J.M. Michalski, C. M. Ma, and David C. Beyer
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Cancer Research ,medicine.medical_specialty ,Radiation ,business.industry ,medicine.medical_treatment ,Compliance (psychology) ,Radiation therapy ,Oncology ,Treatment modality ,medicine ,Physical therapy ,Radiology, Nuclear Medicine and imaging ,Medical physics ,business - Published
- 2016
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6. Patient reported outcomes in NRG Oncology/RTOG 0938, evaluating two ultrahypofractionated regimens (UHR) for prostate cancer (CaP)
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L. Ponsky, Jean-Paul Bahary, Rajat J. Kudchadker, Mack Roach, Guila Delouya, Deborah Watkins Bruner, H. Lukka, Howard M. Sandler, Eric M. Horwitz, Wayne H. Pinover, Jeff M. Michalski, Stephanie L. Pugh, Ian S. Dayes, Samantha A. Seaward, Jason A. Efstathiou, Colleen A. Lawton, Darindra D. Gopaul, David C. Beyer, Lisa A. Kachnic, and Irving D. Kaplan
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,Urinary system ,Phases of clinical research ,EPIC ,medicine.disease ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,Prostate cancer ,0302 clinical medicine ,Quality of life ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,Stage (cooking) ,business - Abstract
27 Background: The considerable interest in short UHR 5-12 fractions(fr) in management of CaP is based on potential radiobiological advantages, patient convenience & resource allocation benefits. Prior to comparison with standard RT regimens (SRTR), a study was undertaken whose primary objective was to demonstrate that 1-year health-related quality of life (HRQOL) for at least one UHR arm was not significantly lower than baseline as measured by the Bowel & Urinary domains EPIC instrument(EPIC B&U). Secondary objectives included acute & late GI & GU toxicity. Methods: RTOG 0938 is a randomized phase II study of CaP patients(pts), (Gleason score 2-6, stage T1-2a & PSA < 10 ng/mL) receiving 36.25 Gy (5 fr of 7.25 Gy in 2 wks), or 51.6 Gy (12 fr of 4.3 Gy in 2.5 wks). Pts were stratified according to RT technique – Cyberknife vs IMRT/VMAT or protons. A change in EPIC bowel domain score (baseline to 1-year) > 5 points & in EPIC urinary domain score > 2 points were felt to be clinically significant. The frequency for > 5 point change in bowel score (FREQE-B) in ≤ 35% of pts was considered acceptable, with the frequency ≥ 55% unacceptable. Similarly, the frequency for > 2 point change in urinary score (FREQE-U) in ≤ 40% was considered acceptable, with the frequency ≥ 60% unacceptable. A sample size of 156 pts was needed for 95% power with one-sided significance level of 0.025 to preserve an overall level of 0.05. Results: 240 pts were enrolled to ensure adequacy of data for analysis. The compliance for HRQOL completion was good ( > 80%). The 1 year FREQE-B for 5 fr was 23.5% (p < 0.001) & 12 fr was 23.1% (p < 0.001). The 1 year FREQE-U for 5 fr was 35.3% (p < 0.001) & 12 fr was 34.7% (p < 0.001). Conclusions: This study confirms that based on changes in EPIC B&U (baseline to 1-year), acute & late toxicity, both the 5 & 12 fr regimens are well tolerated. These UHR need to be compared to current SRTR in the context of a RCT with efficacy & toxicity endpoints. Supported by grants U10CA21661, U10CA180868, U10CA180822, U10CA37422, UG1CA189867 from the National Cancer Institute (NCI). Clinical trial information: NCT01434290. [Table: see text]
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- 2016
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7. Patient-Reported Outcomes in NRG Oncology/RTOG 0938, a Randomized Phase 2 Study Evaluating 2 Ultrahypofractionated Regimens (UHRs) for Prostate Cancer
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Darindra D. Gopaul, L. Ponsky, Jean-Paul Bahary, Deborah Watkins Bruner, Himu Lukka, P. Stephanie, Jason A. Efstathiou, Colleen A. Lawton, Eric M. Horwitz, David C. Beyer, Guila Delouya, Irving D. Kaplan, H.M. Sandler, Lisa A. Kachnic, J.M. Michalski, Rajat J. Kudchadker, Wayne H. Pinover, Ian S. Dayes, Samantha A. Seaward, and M. Roach
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Oncology ,Cancer Research ,medicine.medical_specialty ,Radiation ,business.industry ,Medical school ,University hospital ,medicine.disease ,03 medical and health sciences ,Prostate cancer ,0302 clinical medicine ,Regional cancer ,030220 oncology & carcinogenesis ,Internal medicine ,Cancer centre ,medicine ,Radiology, Nuclear Medicine and imaging ,030212 general & internal medicine ,General hospital ,business - Abstract
Patient-Reported Outcomes in NRG Oncology/RTOG 0938, a Randomized Phase 2 Study Evaluating 2 Ultrahypofractionated Regimens (UHRs) for Prostate Cancer H. Lukka, P. Stephanie, D. Bruner, J.P. Bahary, C.A.F. Lawton, J.A. Efstathiou, R. Kudchadker, L. Ponsky, S.A. Seaward, I.S. Dayes, D.D. Gopaul, J.M. Michalski, G. Delouya, I.D. Kaplan, E.M. Horwitz, M. Roach, III, W.H. Pinover, D.C. Beyer, H.M. Sandler, and L.A. Kachnic; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON, Canada, NRG Oncology Statistics and Data Management Center, Philadelphia, PA, Emory University, Atlanta, GA, Hopital Notre-Dame du CHUM, Montreal, QC, Canada, Medical College of Wisconsin, Milwaukee, WI, Massachusetts General Hospital, Harvard Medical School, Boston, MA, MD Anderson Cancer Center, Houston, TX, United States, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, OH, Kaiser Permanente Northern California, Santa Clara, CA, United States, McMaster University, Hamilton, ON, Canada, Grand River Regional Cancer Centre, Kitchener, ON, Canada, Washington University School of Medicine, St. Louis, MO, Centre Hospitalier de l’Universite de Montreal, Montreal, QC, Canada, Beth Israel Deaconess Medical Center, Boston, MA, Fox Chase Cancer Center, Philadelphia, PA, University of California, San Francisco, San Francisco, CA, Abington Memorial Hospital, Abington, PA, United States, Foundation for Cancer Research and Education, Phoenix, AZ, Cedars-Sinai Medical Center, Los Angeles, CA, Boston Medical Center, Boston, MA
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- 2016
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8. Application of Eshelby's Solution to Elastography for Diagnosis of Breast Cancer.
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Shin B, Gopaul D, Fienberg S, and Kwon HJ
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- Breast diagnostic imaging, Elastic Modulus, Female, Finite Element Analysis, Humans, Models, Biological, Phantoms, Imaging, Reproducibility of Results, Algorithms, Breast Neoplasms diagnostic imaging, Elasticity Imaging Techniques methods
- Abstract
Eshelby's solution is the analytical method that can derive the elastic field within and around an ellipsoidal inclusion embedded in a matrix. Since breast tumor can be regarded as an elastic inclusion with different elastic properties from those of surrounding matrix when the deformation is small, we applied Eshelby's solution to predict the stress and strain fields in the breast containing a suspicious lesion. The results were used to investigate the effectiveness of strain ratio (SR) from elastography in representing modulus ratio (MR) that may be the meaningful indicator of the malignancy of the lesion. This study showed that SR significantly underestimates MR and is varied with the shape and the modulus of the lesion. Based on the results from Eshelby's solution and finite element analysis (FEA), we proposed a surface regression model as a polynomial function that can predict the MR of the lesion to the matrix. The model has been applied to gelatin-based phantoms and clinical ultrasound images of human breasts containing different types of lesions. The results suggest the potential of the proposed method to improve the diagnostic performance of breast cancer using elastography., (© The Author(s) 2015.)
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- 2016
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