Radiation Oncology Publicationshttp://hdl.handle.net/20.500.14038/2222024-03-29T02:09:30Z2024-03-29T02:09:30ZThe Importance of Quality Assurance in Radiation Oncology Clinical TrialsFitzGerald, Thomas JBishop-Jodoin, MaryannLaurie, FranIandoli, MatthewSmith, KorenUlin, KennethDing, LindaMoni, JanakiCicchetti, M GiuliaKnopp, MichaelKry, StephenXiao, YingRosen, MarkPrior, FredSaltz, JoelMichalski, Jeffhttp://hdl.handle.net/20.500.14038/526662023-10-30T14:20:00Z2023-10-01T00:00:00ZThe Importance of Quality Assurance in Radiation Oncology Clinical Trials
FitzGerald, Thomas J; Bishop-Jodoin, Maryann; Laurie, Fran; Iandoli, Matthew; Smith, Koren; Ulin, Kenneth; Ding, Linda; Moni, Janaki; Cicchetti, M Giulia; Knopp, Michael; Kry, Stephen; Xiao, Ying; Rosen, Mark; Prior, Fred; Saltz, Joel; Michalski, Jeff
Clinical trials have been the center of progress in modern medicine. In oncology, we are fortunate to have a structure in place through the National Clinical Trials Network (NCTN). The NCTN provides the infrastructure and a forum for scientific discussion to develop clinical concepts for trial design. The NCTN also provides a network group structure to administer trials for successful trial management and outcome analyses. There are many important aspects to trial design and conduct. Modern trials need to ensure appropriate trial conduct and secure data management processes. Of equal importance is the quality assurance of a clinical trial. If progress is to be made in oncology clinical medicine, investigators and patient care providers of service need to feel secure that trial data is complete, accurate, and well-controlled in order to be confident in trial analysis and move trial outcome results into daily practice. As our technology has matured, so has our need to apply technology in a uniform manner for appropriate interpretation of trial outcomes. In this article, we review the importance of quality assurance in clinical trials involving radiation therapy. We will include important aspects of institution and investigator credentialing for participation as well as ongoing processes to ensure that each trial is being managed in a compliant manner. We will provide examples of the importance of complete datasets to ensure study interpretation. We will describe how successful strategies for quality assurance in the past will support new initiatives moving forward.
2023-10-01T00:00:00ZRisk of Subsequent Neoplasms in Childhood Cancer Survivors After Radiation Therapy: A Comprehensive PENTEC ReviewCasey, Dana LVogelius, Ivan RBrodin, N PatrikRoberts, Kenneth BAvanzo, MicheleMoni, JanakiOwens, ConstanceRonckers, Cécile MConstine, Louis SBentzen, Soren MOlch, Arthurhttp://hdl.handle.net/20.500.14038/528122023-11-30T20:26:32Z2023-09-29T00:00:00ZRisk of Subsequent Neoplasms in Childhood Cancer Survivors After Radiation Therapy: A Comprehensive PENTEC Review
Casey, Dana L; Vogelius, Ivan R; Brodin, N Patrik; Roberts, Kenneth B; Avanzo, Michele; Moni, Janaki; Owens, Constance; Ronckers, Cécile M; Constine, Louis S; Bentzen, Soren M; Olch, Arthur
Purpose: A Pediatric Normal Tissue Effects in the Clinic (PENTEC) analysis of published investigations of central nervous system (CNS) subsequent neoplasms (SNs), subsequent sarcomas, and subsequent lung cancers in childhood cancer survivors who received radiation therapy (RT) was performed to estimate the effect of RT dose on the risk of SNs and the modification of this risk by host and treatment factors.
Methods and materials: A systematic literature review was performed to identify data published from 1975 to 2022 on SNs after prior RT in childhood cancer survivors. After abstract review, usable quantitative and qualitative data were extracted from 83 studies for CNS SNs, 118 for subsequent sarcomas, and 10 for lung SNs with 4 additional studies (3 for CNS SNs and 1 for lung SNs) later added. The incidences of SNs, RT dose, age, sex, primary cancer diagnosis, chemotherapy exposure, and latent time from primary diagnosis to SNs were extracted to assess the factors influencing risk for SNs. The excess relative ratio (ERR) for developing SNs as a function of dose was analyzed using inverse-variance weighted linear regression, and the ERR/Gy was estimated. Excess absolute risks were also calculated.
Results: The ERR/Gy for subsequent meningiomas was estimated at 0.44 (95% CI, 0.19-0.68); for malignant CNS neoplasms, 0.15 (95% CI, 0.11-0.18); for sarcomas, 0.045 (95% CI, 0.023-0.067); and for lung cancer, 0.068 (95% CI, 0.03-0.11). Younger age at time of primary diagnosis was associated with higher risk of subsequent meningioma and sarcoma, whereas no significant effect was observed for age at exposure for risk of malignant CNS neoplasm, and insufficient data were available regarding age for lung cancer. Females had a higher risk of subsequent meningioma (odds ratio, 1.46; 95% CI, 1.22-1.76; P < .0001) relative to males, whereas no statistically significant sex difference was seen in risk of malignant CNS neoplasms, sarcoma SNs, or lung SNs. There was an association between chemotherapy receipt (specifically alkylating agents and anthracyclines) and subsequent sarcoma risk, whereas there was no clear association between specific chemotherapeutic agents and risk of CNS SNs and lung SNs.
Conclusions: This PENTEC systematic review shows a significant radiation dose-response relationship for CNS SNs, sarcomas, and lung SNs. Given the linear dose response, improved conformality around the target volume that limits the high dose volume might be a promising strategy for reducing the risk of SNs after RT. Other host- and treatment-related factors such as age and chemotherapy play a significant contributory role in the development of SNs and should be considered when estimating the risk of SNs after RT among childhood cancer survivors.
2023-09-29T00:00:00ZChildren's Oncology Group's 2023 blueprint for research: Radiation oncologyKalapurakal, John AWolden, Suzanne LHaas-Kogan, DaphneLaack, Nadia NHua, Chia-HoPaulino, Arnold CHill-Kayser, Christine EHoppe, Bradford SFitzGerald, Thomas Jhttp://hdl.handle.net/20.500.14038/523952023-08-10T18:22:05Z2023-07-24T00:00:00ZChildren's Oncology Group's 2023 blueprint for research: Radiation oncology
Kalapurakal, John A; Wolden, Suzanne L; Haas-Kogan, Daphne; Laack, Nadia N; Hua, Chia-Ho; Paulino, Arnold C; Hill-Kayser, Christine E; Hoppe, Bradford S; FitzGerald, Thomas J
Radiation oncology is an integral part of the multidisciplinary team caring for children with cancer. The primary goal of our committee is to enable the delivery of the safest dose of radiation therapy (RT) with the maximal potential for cure, and to minimize toxicity in children by delivering lower doses to normal tissues using advanced technologies like intensity-modulated RT (IMRT) and proton therapy. We provide mentorship for y ators and are actively involved in educating the global radiation oncology community. We are leaders in the effort to discover novel radiosensitizers, radioprotectors, and advanced RT technologies that could help improve outcomes of children with cancer.
2023-07-24T00:00:00ZEditorial: Rising stars in radiation oncology 2022FitzGerald, Thomas Jhttp://hdl.handle.net/20.500.14038/523962023-08-11T05:04:27Z2023-06-21T00:00:00ZEditorial: Rising stars in radiation oncology 2022
FitzGerald, Thomas J
As patient care has matured and become increasingly complex, the fundamental skill set for the modern radiation oncologist has evolved as well. The initial generation of radiation oncologists trained in the United States and North America were taught by highly skilled mentors with expertise in surface anatomy and fluoroscopy with radiation fields designed by common understanding of the pattern of disease spread. Our first-generation mentors were critical thought leaders in applying management tools available at that time to trainees. This generation of radiation oncologists applied their expertise with the tools of the day; however, as our technology has evolved, the modern radiation oncologist requires skills commensurate with rapid technology changes. As we evolve and mature as thought leaders in the oncology practice of today, the skills required for the modern radiation oncologist both in clinical care and in basic science evolve and reach a new level of performance to match expectations of our colleagues and patients.
2023-06-21T00:00:00ZQuality improvements in radiation oncology clinical trialsSmith, KorenUlin, KennethKnopp, MichaelKry, StephanXiao, YingRosen, MarkMichalski, JeffIandoli, MatthewLaurie, FranQuigley, JeanReifler, HeatherSantiago, JuanBriggs, KathleenKirby, ShawnSchmitter, KatePrior, FredSaltz, JoelSharma, AshishBishop-Jodoin, MaryannMoni, JanakiCicchetti, M GiuliaFitzGerald, Thomas Jhttp://hdl.handle.net/20.500.14038/518022023-03-14T04:38:17Z2023-01-26T00:00:00ZQuality improvements in radiation oncology clinical trials
Smith, Koren; Ulin, Kenneth; Knopp, Michael; Kry, Stephan; Xiao, Ying; Rosen, Mark; Michalski, Jeff; Iandoli, Matthew; Laurie, Fran; Quigley, Jean; Reifler, Heather; Santiago, Juan; Briggs, Kathleen; Kirby, Shawn; Schmitter, Kate; Prior, Fred; Saltz, Joel; Sharma, Ashish; Bishop-Jodoin, Maryann; Moni, Janaki; Cicchetti, M Giulia; FitzGerald, Thomas J
Clinical trials have become the primary mechanism to validate process improvements in oncology clinical practice. Over the past two decades there have been considerable process improvements in the practice of radiation oncology within the structure of a modern department using advanced technology for patient care. Treatment planning is accomplished with volume definition including fusion of multiple series of diagnostic images into volumetric planning studies to optimize the definition of tumor and define the relationship of tumor to normal tissue. Daily treatment is validated by multiple tools of image guidance. Computer planning has been optimized and supported by the increasing use of artificial intelligence in treatment planning. Informatics technology has improved, and departments have become geographically transparent integrated through informatics bridges creating an economy of scale for the planning and execution of advanced technology radiation therapy. This serves to provide consistency in department habits and improve quality of patient care. Improvements in normal tissue sparing have further improved tolerance of treatment and allowed radiation oncologists to increase both daily and total dose to target. Radiation oncologists need to define a priori dose volume constraints to normal tissue as well as define how image guidance will be applied to each radiation treatment. These process improvements have enhanced the utility of radiation therapy in patient care and have made radiation therapy an attractive option for care in multiple primary disease settings. In this chapter we review how these changes have been applied to clinical practice and incorporated into clinical trials. We will discuss how the changes in clinical practice have improved the quality of clinical trials in radiation therapy. We will also identify what gaps remain and need to be addressed to offer further improvements in radiation oncology clinical trials and patient care.
2023-01-26T00:00:00ZApproach to Stereotactic Body Radiotherapy for the Treatment of Advanced Hepatocellular Carcinoma in Patients with Child-Pugh B-7 CirrhosisDaniell, Kayla MBanson, Kara MicahDiamond, Brett HSioshansi, Shirinhttp://hdl.handle.net/20.500.14038/513532022-11-30T02:53:22Z2022-11-05T00:00:00ZApproach to Stereotactic Body Radiotherapy for the Treatment of Advanced Hepatocellular Carcinoma in Patients with Child-Pugh B-7 Cirrhosis
Daniell, Kayla M; Banson, Kara Micah; Diamond, Brett H; Sioshansi, Shirin
Patients with hepatocellular carcinoma (HCC) with underlying Child-Pugh B-7 cirrhosis benefit from management from an experienced, multidisciplinary team. In patients with localized disease who meet criteria for liver transplant, establishing care at a liver transplant center is crucial. For those awaiting transplant, local bridge therapies have emerged as a strategy to maintain priority status and eligibility. Multiple liver-directed therapies exist to provide locoregional tumor control. The careful selection of locoregional therapy is a multidisciplinary endeavor that takes into account patient factors including tumor resectability, underlying liver function, performance status, previous treatment, tumor location/size, and vascular anatomy to determine the optimal management strategy. Technological advances in external beam radiation therapy have allowed stereotactic body radiation therapy (SBRT) to emerge in recent years as a versatile and highly effective bridge therapy consisting of typically between 3 and 5 high dose, highly focused, and non-invasive radiation treatments. When treating cirrhotic patients with HCC, preserving liver function is of utmost importance to prevent clinical decline and decompensation. SBRT has been shown to be both safe and effective in carefully selected patients with Child-Pugh B cirrhosis; however, care must be taken to prevent radiation-induced liver disease. This review summarizes the evolving role of SBRT in the treatment of HCC in patients with Child-Pugh B-7 cirrhosis.
2022-11-05T00:00:00ZExtranodal presentation in limited-stage diffuse large Bcell lymphoma as a prognostic marker in three SWOG trials S0014, S0313 and S1001Stephens, Deborah MLi, HongliConstine, Louis SFitzgerald, Thomas JLeonard, John PKahl, Brad SSong, Joo YLeBlanc, Michael LSmith, Sonali MPersky, Daniel OFriedberg, Jonathan Whttp://hdl.handle.net/20.500.14038/513552022-11-30T02:51:58Z2022-11-01T00:00:00ZExtranodal presentation in limited-stage diffuse large Bcell lymphoma as a prognostic marker in three SWOG trials S0014, S0313 and S1001
Stephens, Deborah M; Li, Hongli; Constine, Louis S; Fitzgerald, Thomas J; Leonard, John P; Kahl, Brad S; Song, Joo Y; LeBlanc, Michael L; Smith, Sonali M; Persky, Daniel O; Friedberg, Jonathan W
Several recent trials have changed the standard-of-care for patients with limited stage (LS) diffuse large B-cell lymphoma (DLBCL) by minimizing the number of chemoimmunotherapy cycles and/or eliminating the need for radiotherapy without compromising long-term outcomes. However, there may be patient subsets where an abbreviated-treatment approach is insufficient. With this in mind, Bobillo et al., retrospectively reviewed LS DLBCL patients treated at a single institution with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (RCHOP) for four to six cycles with or without radio-therapy. This group reported that an extranodal presentation had shorter progression-free (PFS) and overall survival (OS) compared with nodal presentation. In these patients, consolidative radiotherapy prolonged survival in patients with extranodal disease, especially those with a positive positron emission tomography (PET) scan at the end of chemoimmunotherapy. In response, we analyzed similar patients treated on three consecutive SWOG studies (S0014, S0313, S1001; clinicaltrails gov. Identifier: NCT00005089, NCT00070018, NCT01359592).
2022-11-01T00:00:00ZDefinitive Radiation Therapy for Medically Inoperable Endometrial CarcinomaShen, James LO'Connor, Kevin WMoni, JanakiZweizig, SusanFitzGerald, Thomas JKo, Eric Chttp://hdl.handle.net/20.500.14038/518002023-03-14T04:37:59Z2022-10-25T00:00:00ZDefinitive Radiation Therapy for Medically Inoperable Endometrial Carcinoma
Shen, James L; O'Connor, Kevin W; Moni, Janaki; Zweizig, Susan; FitzGerald, Thomas J; Ko, Eric C
Purpose: Upfront radiation therapy consisting of brachytherapy with or without external beam radiation therapy is considered standard of care for patients with endometrial carcinoma who are unable to undergo surgical intervention. This study evaluated the cancer-free survival (CFS), cancer-specific survival (CSS), and overall survival (OS) of patients with endometrial carcinoma managed with definitive-intent radiation therapy.
Methods and materials: This was a single-institution retrospective analysis of medically inoperable patients with biopsy-proven endometrial carcinoma managed with up-front, definitive radiation therapy at UMass Memorial Medical Center between May 2010 and October 2021. A total of 55 cases were included for analysis. Patients were stratified as having low-risk endometrial carcinoma (LREC; uterine-confined grade 1-2 endometrioid adenocarcinoma) or high-risk endometrial carcinoma (HREC; stage III/IV and/or grade 3 endometrioid carcinoma, or any stage serous or clear cell carcinoma or carcinosarcoma). The CFS, CSS, OS, and grade ≥3 toxic effects were reported for patients with LREC and HREC.
Results: The median age was 66 years (range, 42-86 years), and the median follow-up was 44 months (range, 4-135 months). Twelve patients (22%) were diagnosed with HREC. Six patients (11%) were treated with high-dose-rate brachytherapy alone and 49 patients (89%) were treated with high-dose-rate brachytherapy and external beam radiation therapy. Twelve patients (22%) were treated with radiation and chemotherapy. The 2-year CFS was 82% for patients with LREC and 80% for patients with HREC (log rank P = .0654). The 2-year CSS was 100% for both LREC and HREC patients. The 2-year OS was 92% for LREC and 80% for HREC (log P = .0064). There were no acute grade ≥3 toxic effects. There were 3 late grade ≥3 toxic effects owing to endometrial bleeding and gastrointestinal adverse effects.
Conclusions: For medically inoperable patients with endometrial carcinoma, up-front radiation therapy provided excellent CFS, CSS, and OS. The CSS and OS were higher in patients with LREC than in those with HREC. Toxic effects were limited in both cohorts.
2022-10-25T00:00:00ZProstate Cancer: Advances in Radiation Oncology, Molecular Biology, and Future Treatment StrategiesWang, TaoLewis, BrianRuscetti, MarcusMittal, KritiWang, Ming-JinSokoloff, Mitchell H.Ding, LindaBishop-Jodoin, MaryannFitzGerald, Thomas J.http://hdl.handle.net/20.500.14038/513562023-02-10T16:14:22Z2022-09-12T00:00:00ZProstate Cancer: Advances in Radiation Oncology, Molecular Biology, and Future Treatment Strategies
Wang, Tao; Lewis, Brian; Ruscetti, Marcus; Mittal, Kriti; Wang, Ming-Jin; Sokoloff, Mitchell H.; Ding, Linda; Bishop-Jodoin, Maryann; FitzGerald, Thomas J.
Prostate cancer remains an important health problem worldwide affecting one in every six men including members of vulnerable communities. Although successful treatments have been delivered to men affected with the disease resulting in improved patient outcome, process improvements including therapy titration and augmentation are needed to optimize tumor control and limit normal tissue injury from therapy. In this chapter, we describe current management strategies for optimal patient care with radiation therapy and opportunities for improvement of care moving forward with applied science to apply therapy in a strategic manner, potentially improving care and outcome for patients treated for this disease.
2022-09-12T00:00:00ZRadiation Oncology: Future Vision for Quality Assurance and Data Management in Clinical Trials and Translational ScienceDing, LindaBradford, CarlaKuo, I-LinFan, YankhuaUlin, KennethKhalifeh, AbdulnasserYu, SuhongLiu, FenghongSaleeby, JonathanBushe, HarrySmith, KorenBianciu, CameliaLaRosa, SalvatorePrior, FredSaltz, JoelSharma, AshishSmyczynski, Mark S.Bishop-Jodoin, MaryannLaurie, FranIandoli, MatthewMoni, JanakiCicchetti, M GiuliaFitzGerald, Thomas Jhttp://hdl.handle.net/20.500.14038/513542024-03-27T13:49:18Z2022-08-10T00:00:00ZRadiation Oncology: Future Vision for Quality Assurance and Data Management in Clinical Trials and Translational Science
Ding, Linda; Bradford, Carla; Kuo, I-Lin; Fan, Yankhua; Ulin, Kenneth; Khalifeh, Abdulnasser; Yu, Suhong; Liu, Fenghong; Saleeby, Jonathan; Bushe, Harry; Smith, Koren; Bianciu, Camelia; LaRosa, Salvatore; Prior, Fred; Saltz, Joel; Sharma, Ashish; Smyczynski, Mark S.; Bishop-Jodoin, Maryann; Laurie, Fran; Iandoli, Matthew; Moni, Janaki; Cicchetti, M Giulia; FitzGerald, Thomas J
The future of radiation oncology is exceptionally strong as we are increasingly involved in nearly all oncology disease sites due to extraordinary advances in radiation oncology treatment management platforms and improvements in treatment execution. Due to our technology and consistent accuracy, compressed radiation oncology treatment strategies are becoming more commonplace secondary to our ability to successfully treat tumor targets with increased normal tissue avoidance. In many disease sites including the central nervous system, pulmonary parenchyma, liver, and other areas, our service is redefining the standards of care. Targeting of disease has improved due to advances in tumor imaging and application of integrated imaging datasets into sophisticated planning systems which can optimize volume driven plans created by talented personnel. Treatment times have significantly decreased due to volume driven arc therapy and positioning is secured by real time imaging and optical tracking. Normal tissue exclusion has permitted compressed treatment schedules making treatment more convenient for the patient. These changes require additional study to further optimize care. Because data exchange worldwide have evolved through digital platforms and prisms, images and radiation datasets worldwide can be shared/reviewed on a same day basis using established de-identification and anonymization methods. Data storage post-trial completion can co-exist with digital pathomic and radiomic information in a single database coupled with patient specific outcome information and serve to move our translational science forward with nimble query elements and artificial intelligence to ask better questions of the data we collect and collate. This will be important moving forward to validate our process improvements at an enterprise level and support our science. We have to be thorough and complete in our data acquisition processes, however if we remain disciplined in our data management plan, our field can grow further and become more successful generating new standards of care from validated datasets.
2022-08-10T00:00:00Z