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3. Challenges and opportunities for early phase clinical trials of novel drug–radiotherapy combinations: recommendations from NRG Oncology, the American Society for Radiation Oncology (ASTRO), the American College of Radiology (ACR), the Sarah Cannon Research Institute, and the American College of Radiation Oncology (ACRO)

Author

Zumsteg, Zachary S, Sheth, Siddharth, Jabbour, Salma K, Patel, Krishnan R, Kimple, Randall J, Williams, Terence M, Xu-Welliver, Meng, Torres-Saavedra, Pedro A, Monjazeb, Arta M, Mayadev, Jyoti, Finkelstein, Steven E, Buatti, John M, Patel, Sandip P, and Lin, Steven H

Published
2024
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7. The Society of Thoracic Surgeons/American Society for Radiation Oncology Updated Clinical Practice Guidelines on Multimodality Therapy for Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

Author

Worrell, Stephanie G., Goodman, Karyn A., Altorki, Nasser K., Ashman, Jonathan B., Crabtree, Traves D., Dorth, Jennifer, Firestone, Scott, Harpole, David H., Hofstetter, Wayne L., Hong, Theodore S., Kissoon, Kalie, Ku, Geoffrey Y., Molena, Daniela, Tepper, Joel E., Watson, Thomas J., Williams, Terence, and Willett, Christopher

Published
2024
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18. National Cancer Institute (NCI) state of the science: Targeted radiosensitizers in colorectal cancer

Author

George, Thomas J, Franke, Aaron J, Chakravarthy, A Bapsi, Das, Prajnan, Dasari, Arvind, El‐Rayes, Bassel F, Hong, Theodore S, Kinsella, Timothy J, Landry, Jerome C, Lee, James J, Monjazeb, Arta M, Jacobs, Samuel A, Raben, David, Rahma, Osama E, Williams, Terence M, Wu, Christina, Coleman, C Norman, Vikram, Bhadrasain, and Ahmed, Mansoor M

Subjects
Digestive Diseases, Cancer, Clinical Research, Patient Safety, Biotechnology, Colo-Rectal Cancer, Good Health and Well Being, Antineoplastic Agents, Immunological, B7-H1 Antigen, Biological Products, Colorectal Neoplasms, HSP90 Heat-Shock Proteins, Herpesvirus 1, Human, Humans, Immunotherapy, Mitogen-Activated Protein Kinases, Molecular Targeted Therapy, National Cancer Institute (U.S.), Protein Kinase C, Pyrimidine Nucleosides, Radiation-Sensitizing Agents, United States, abscopal effect, chemoradiotherapy, colorectal cancer, immunotherapy, precision radiation medicine, radiation biology, radiation therapy, radiosensitization, rectal cancer, targeted therapeutics, Oncology and Carcinogenesis, Public Health and Health Services, Oncology & Carcinogenesis
Abstract

Colorectal cancer (CRC) represents a major public health problem as the second leading cause of cancer-related mortality in the United States. Of an estimated 140,000 newly diagnosed CRC cases in 2018, roughly one-third of these patients will have a primary tumor located in the distal large bowel or rectum. The current standard-of-care approach includes curative-intent surgery, often after preoperative (neoadjuvant) radiotherapy (RT), to increase rates of tumor down-staging, clinical and pathologic response, as well as improving surgical resection quality. However, despite advancements in surgical techniques, as well as sharpened precision of dosimetry offered by contemporary RT delivery platforms, the oncology community continues to face challenges related to disease relapse. Ongoing investigations are aimed at testing novel radiosensitizing agents and treatments that might exploit the systemic antitumor effects of RT using immunotherapies. If successful, these treatments may usher in a new curative paradigm for rectal cancers, such that surgical interventions may be avoided. Importantly, this disease offers an opportunity to correlate matched paired biopsies, radiographic response, and molecular mechanisms of treatment sensitivity and resistance with clinical outcomes. Herein, the authors highlight the available evidence from preclinical models and early-phase studies, with an emphasis on promising developmental therapeutics undergoing prospective validation in larger scale clinical trials. This review by the National Cancer Institute's Radiation Research Program Colorectal Cancer Working Group provides an updated, comprehensive examination of the continuously evolving state of the science regarding radiosensitizer drug development in the curative treatment of CRC.

Published
2019

22. The International Association for the Study of Lung Cancer Thymic Epithelial Tumor Staging Project: Unresolved Issues to be Addressed for the Next Ninth Edition of the TNM Classification of Malignant Tumors

Author

Asamura, Hisao, Rusch, Valerie, Rami-Porta, Ramon, Araujo, Luiz Henrique, Beer, David, Bertoglio, Pietro, Beyruti, Ricardo, Bille, Andrea, Boubia, Souheil, Brambilla, Elisabeth, Cangir, A.K., Cilento, Vanessa, Connolly, Casey, Darling, Gail, Detterbeck, Frank, Dibaba, Daniel, D’ Journo, Xavier Benoit, Eberhardt, Wilfried, Erasmus, Jeremy, Fang, Wentao, Fennell, Dean, Fong, Kwun, Galateau-Salle, Françoise, Gill, Ritu R., Giroux, Dorothy, Giuliani, Meredith, Goo, Jin Mo, Hirsch, Fred, Hoffman, Hans, Hofstetter, Wayne, Huang, James, Joubert, Philippe, Kernstine, Kemp, Kerr, Keith, Kim, Young Tae, Kim, Dong Kwan, Lievens, Yolande, Liu, Hui, Low, Donald E., Lyons, Gustavo, MacMahon, Heber, Marino, Mirella, Marom, Edith M., Matilla, José-María, Meerbeeck, Jan van, Montuenga, Luis M., Nicholson, Andrew, Nishimura, Katie, Nowak, Anna, Opitz, Isabelle, Okumura, Meinoshin, Osarogiagbon, Raymond U., Pass, Harvey, de Perrot, Marc, Rice, David, Rosenthal, Adam, Ruffini, Enrico, Sakai, Shuji, Van Schil, Paul, Singh, Navneet, Suárez, Francisco, Terra, Ricardo M., Travis, William D., Tsao, Ming S., Ugalde, Paula, Watanabe, Shun-Ichi, Wistuba, Ignacio, Wynes, Murry, Yatabe, Yasushi, Appel, Sarit, Armato, Samuel, Berzenji, Lawek, Brunelli, Alex, Cardillo, Giuseppe, Chen, Keneng, Cooper, Wendy, Filosso, Pier Luigi, Jiang, Liyan, Krasnik, Mark, Kubota, Kauro, Labbe, Catherine, Lee, Ho Yun, Lim, Eric, Liu, Geoffrey, Liu, Hongxu, Mack, Philip, Naidich, David, Nishino, Mizuki, Ostrowski, Marcin, Powell, Charles, Presley, Carolyn, Putora, Paul Martin, Ren, Harry, Rivera, M. Patricia, Rocco, Gaetano, Ruiz Tzukazan, Maria Teresa, Samstein, Robert, Soon, Yu Yang, Suda, Kenichi, Tammemägi, Martin, Turna, Akif, Weksler, Benny, Williams, Terence, Yang, Dawei, Yang, Jeff, Yotsukura, Masaya, Ahmad, Usman, Brambilla, Cecilia, Falkson, Conrad B., Giaccone, Giuseppe, Guerrera, Francesco, Infante, Maurizio, Lucchi, Marco, Simone, Charles B., II, Ferguson, Mark, Sauter, Jennifer, Wolf, Andrea, Falkson, Conrad, Filosso, Pier Liugi, Girard, Nicolas, Kim, Hong Kwan, Rimner, Andreas, Kim, Hong Kwuan, Cangir, Ayten Kayi, and Nicholson, Andrew G.

Published
2022
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23. Phase I study of trametinib in combination with whole brain radiation therapy for brain metastases

Author

Palmer, Joshua D., Prasad, Rahul N., Fabian, Denise, Wei, Lai, Yildiz, Vedat O., Tan, Yubo, Grecula, John, Welliver, Meng, Williams, Terence, Elder, James B., Raval, Raju, Blakaj, Dukagjin, Haglund, Karl, Bazan, Jose, Kendra, Kari, Arnett, Andrea, Beyer, Sasha, Liebner, David, Giglio, Pierre, Puduvalli, Vinay, Chakravarti, Arnab, and Wuthrick, Evan

Published
2022
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24. A Phase 2 Trial of Primary Tumor Stereotactic Body Radiation Therapy Boost Before Concurrent Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer.

Author

Williams, Terence M., Miller, Eric, Welliver, Meng, Brownstein, Jeremy, Otterson, Gregory, Owen, Dwight, Haglund, Karl, Shields, Peter, Bertino, Erin, Presley, Carolyn, He, Kai, Jacob, Naduparambil K., Walston, Steve, Pan, Jeff, Yang, Xiangyu, Knopp, Michael, Essan, Jean Koutou, McElroy, Joseph, Mo, Xiaokui, and McElroy, Sohyun

Subjects
*FUNCTIONAL magnetic resonance imaging, *STEREOTACTIC radiotherapy, *NON-small-cell lung carcinoma, *OVERALL survival, *RADIATION pneumonitis
Abstract

Primary tumor failure is common in patients treated with chemoradiation (CRT) for locally advanced NSCLC (LA-NSCLC). Stereotactic body radiation therapy (SBRT) yields high rates of primary tumor control (PTC) in early-stage NSCLC. This trial tested an SBRT boost to the primary tumor before the start of CRT to improve PTC. Patients with LA-NSCLC received an SBRT boost in 2 fractions (central location 12 Gy, peripheral location 16 Gy) to the primary tumor, followed by standard CRT (60 Gy in 30 fractions). The primary objective was PTC rate at 1 year, and the hypothesis was that the 1-year PTC rate would be ≥90%. Secondary objectives included objective response rate, regional and distant control, disease-free survival (DFS), and overall survival (OS). Correlative studies included functional magnetic resonance imaging and blood-based miRNA analysis. The study enrolled 21 patients (10 men and 11 women); the median age was 62 years (range, 52-78). The median pretreatment primary tumor size was 5.0 cm (range, 1.0-8.3). The most common nonhematologic toxicities were pneumonitis, fatigue, esophagitis/dysphagia, dyspnea, and cough. Only 1 treatment-related grade 4 nonhematologic toxicity occurred (respiratory failure/radiation pneumonitis), and no grade 5 toxicities occurred. The objective response rate at 3 and 6 months was 72.7% and 80.0%, respectively, and PTC at 1 and 2 years was 100% and 92.3%, respectively. The 2-year regional and distant control rates were 81.6% and 70.3%, respectively. Disease-free survival and overall survival at 2 years were 46.1% and 50.3%, respectively, and median survival was 37.8 months. Functional magnetic resonance imaging detected a mean relative decrease in blood oxygenation level–dependent signal of –87.1% (P =.05), and miR.142.3p was correlated with increased risk of grade ≥3 pulmonary toxicity (P =.01). Dose escalation to the primary tumor using upfront SBRT appears feasible and safe. PTC was high and other oncologic endpoints compared favorably to standard treatment. Functional magnetic resonance imaging suggested changes in oxygenation with the first SBRT boost dose, and miR.142.3p was correlated with pulmonary toxicity. [ABSTRACT FROM AUTHOR]

Published
2024
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28. A randomized phase II trial of atezolizumab with or without tiragolumab before and after definitive chemoradiation for unresectable stage III non-small cell lung cancer (NSCLC; AFT-57).

Author

Ross, Helen J., primary, Kozono, David E., additional, Mix, Michael D, additional, Urbanic, James John, additional, Williams, Terence Marques, additional, O'Donnell, Taylor, additional, Bara, Ilze, additional, Schulze, Katja, additional, Wang, Xiaofei F., additional, Nelson, Garth D., additional, and Stinchcombe, Tom, additional

Published
2024
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35. Atezolizumab Before and After Chemoradiation for Unresectable Stage III Non–Small Cell Lung Cancer: A Phase II Nonrandomized Controlled Trial.

Author

Ross, Helen J., Kozono, David, Wang, Xiaofei F., Urbanic, James John, Williams, Terence M., Nelson, Garth D., Carbone, David P., Chung, Dongjun, Robb, Ryan, Byun, Woo Yul, Talabere, Tiffany, DuFrane, Carter, Bara, Ilze, Schulze, Katja, Brockman, Michelle, Gao, Junheng, Vokes, Everett E., and Stinchcombe, Thomas E.

Published
2024
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38. Nutrient scavenging-fueled growth in pancreatic cancer depends on caveolae-mediated endocytosis under nutrient-deprived conditions

Author

Wolfe, Adam R., primary, Cui, Tiantian, additional, Baie, Sooin, additional, Corrales-Guerrero, Sergio, additional, Webb, Amy, additional, Castro-Aceituno, Veronica, additional, Shyu, Duan-Liang, additional, Karasinska, Joanna M., additional, Topham, James T., additional, Renouf, Daniel J., additional, Schaeffer, David F., additional, Halloran, Megan, additional, Packard, Rebecca, additional, Robb, Ryan, additional, Chen, Wei, additional, Denko, Nicholas, additional, Lisanti, Michael, additional, Thompson, Timothy C., additional, Frank, Philippe, additional, and Williams, Terence M., additional

Published
2024
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39. A Phase II Trial of Primary Tumor SBRT Boost Prior to Concurrent Chemoradiation for Locally-Advanced Non-Small Cell Lung Cancer

Author

Williams, Terence M., primary, Miller, Eric, additional, Welliver, Meng, additional, Brownstein, Jeremy, additional, Otterson, Gregory, additional, Owen, Dwight, additional, Haglund, Karl, additional, Shields, Peter, additional, Bertino, Erin, additional, Presley, Carolyn, additional, He, Kai, additional, Naduparambil, Jacob, additional, Walston, Steve, additional, Pan, Jeff, additional, Yang, Xiangyu, additional, Knopp, Michael, additional, Essan, Jean Koutou, additional, McElroy, Joseph, additional, Mo, Xiaokui, additional, McElroy, Sohyun, additional, Carbone, David, additional, and Bazan, Jose, additional

Published
2024
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40. Initial safety assessment of the endoscopically injected oncolytic virus OBP-301 in medically inoperable esophageal cancer: NRG-GI007.

Author

Ku, Geoffrey Yuyat, primary, Moughan, Jennifer, additional, Williams, Terence Marques, additional, Adusumilli, Prasad S., additional, Nishimura, Makoto, additional, Yock, Adam, additional, Mehta, Rutika, additional, Klempner, Samuel J., additional, Miller, Eric David, additional, and Hong, Theodore S., additional

Published
2024
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41. The Society of Thoracic Surgeons/American Society for Radiation Oncology Updated Clinical Practice Guidelines on Multimodality Therapy for Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

Author

Worrell, Stephanie G., primary, Goodman, Karyn A., additional, Altorki, Nasser K., additional, Ashman, Jonathan B., additional, Crabtree, Traves D., additional, Dorth, Jennifer, additional, Firestone, Scott, additional, Harpole, David H., additional, Hofstetter, Wayne L., additional, Hong, Theodore S., additional, Kissoon, Kalie, additional, Ku, Geoffrey Y., additional, Molena, Daniela, additional, Tepper, Joel E., additional, Watson, Thomas J., additional, Williams, Terence, additional, and Willett, Christopher, additional

Published
2024
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42. Inter-Fraction Tumor Volume Response during Lung Stereotactic Body Radiation Therapy Correlated to Patient Variables.

Author

Salamekh, Samer, Rong, Yi, Ayan, Ahmet S, Mo, Xiaokui, Williams, Terence M, Mayr, Nina A, Grecula, John C, Chakravarti, Arnab, and Xu-Welliver, Meng

Subjects
Humans, Lung Neoplasms, Radiosurgery, Aged, Aged, 80 and over, Middle Aged, Cone-Beam Computed Tomography, and over, General Science & Technology
Abstract

PurposeAnalyze inter-fraction volumetric changes of lung tumors treated with stereotactic body radiation therapy (SBRT) and determine if the volume changes during treatment can be predicted and thus considered in treatment planning.Methods and materialsKilo-voltage cone-beam CT (kV-CBCT) images obtained immediately prior to each fraction were used to monitor inter-fraction volumetric changes of 15 consecutive patients (18 lung nodules) treated with lung SBRT at our institution (45-54 Gy in 3-5 fractions) in the year of 2011-2012. Spearman's (ρ) correlation and Spearman's partial correlation analysis was performed with respect to patient/tumor and treatment characteristics. Multiple hypothesis correction was performed using False Discovery Rate (FDR) and q-values were reported.ResultsAll tumors studied experienced volume change during treatment. Tumor increased in volume by an average of 15% and regressed by an average of 11%. The overall volume increase during treatment is contained within the planning target volume (PTV) for all tumors. Larger tumors increased in volume more than smaller tumors during treatment (q = 0.0029). The volume increase on CBCT was correlated to the treatment planning gross target volume (GTV) as well as internal target volumes (ITV) (q = 0.0085 and q = 0.0039 respectively) and could be predicted for tumors with a GTV less than 22 mL. The volume increase was correlated to the integral dose (ID) in the ITV at every fraction (q = 0.0049). The peak inter-fraction volume occurred at an earlier fraction in younger patients (q = 0.0122).ConclusionsWe introduced a new analysis method to follow inter-fraction tumor volume changes and determined that the observed changes during lung SBRT treatment are correlated to the initial tumor volume, integral dose (ID), and patient age. Furthermore, the volume increase during treatment of tumors less than 22mL can be predicted during treatment planning. The volume increase remained significantly less than the overall PTV expansion, and radiation re-planning was therefore not required for the purpose of tumor control. The presence of the studied correlations suggests that the observed volumetric changes may reflect some underlying biologic process rather than random fluctuations.

Published
2016

43. Minimal Inter-Fractional Fiducial Migration during Image-Guided Lung Stereotactic Body Radiotherapy Using SuperLock Nitinol Coil Fiducial Markers

Author

Rong, Yi, Bazan, Jose G, Sekhon, Ashley, Haglund, Karl, Xu-Welliver, Meng, and Williams, Terence

Subjects
Lung Cancer, Cancer, Lung, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Aged, Aged, 80 and over, Bronchoscopy, Carcinoma, Non-Small-Cell Lung, Demography, Female, Fiducial Markers, Gamma Rays, Humans, Lung Neoplasms, Male, Middle Aged, Radiosurgery, Radiotherapy, Image-Guided, Retrospective Studies, Tomography, X-Ray Computed, General Science & Technology
Abstract

ObjectivesStereotactic body radiotherapy (SBRT) is being increasingly used for the treatment of patients with lung cancer or lung metastasis who are medically unfit to undergo resection. In order to improve accuracy and confidence in targeting tumors, many centers rely on fiducial implantation. We evaluated the migration of a novel fiducial marker specifically designed for lung tissue implanted via electromagnetic navigation bronchoscopy (ENB).MethodsWe retrospectively quantified the individual and group migrations of SuperLock nitinol coil fiducials for 15 patients receiving lung stereotactic body radiotherapy (SBRT), in order to evaluate the reliability of using these fiducials as a target surrogate for cases where tumors cannot be clearly delineated on cone beam CTs (CBCTs). For each fraction, we compared the individual and group migrations of the fiducials between the planning CT and the acquired CBCT. The group migration was defined as the distance between the centroids of the fiducial group and GTV.ResultsA total of 16 lung targets were included in our study for these 15 patients (one patient with two targets). Of 55 fiducials placed, we observed a 100% retention rate. The mean individual migration was 1.87 mm (range, 0.63-5.25 mm) with a standard deviation of 1.26 mm. The mean group migration was 1.94 mm (range, 0.03-6.19 mm) with a standard deviation of 1.45 mm. Overall, there was minimal change in the relative locations of the markers with respect to each other, as well as to the target.ConclusionsWe found that the SuperLock nitinol coil fiducial marker positions are stable throughout the radiation treatment, and can be used as a reliable surrogate to target, and to avoid geometric misses during gated treatments.

Published
2015

50. Explainable Artificial Intelligence to Identify Dosimetric Predictors of Toxicity in Patients with Locally Advanced Non-Small Cell Lung Cancer: A Secondary Analysis of RTOG 0617

Author

Ladbury, Colton, primary, Li, Richard, additional, Danesharasteh, Anseh, additional, Ertem, Zeynep, additional, Tam, Andrew, additional, Liu, Jason, additional, Hao, Claire, additional, Li, Rose, additional, McGee, Heather, additional, Sampath, Sagus, additional, Williams, Terence, additional, Glaser, Scott, additional, Khasawneh, Mohammad, additional, Liao, Zhongxing, additional, Lee, Percy, additional, Ryckman, Jeff, additional, Shaikh, Parvez, additional, and Amini, Arya, additional

Published
2023
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