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Michalski J.,University of Washington | Michalski J.,Image guided Therapy Center | Winter K.,Radiation Therapy Oncology Group | Roach M.,University of California at San Francisco | And 10 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2012

Purpose: Report of clinical cancer control outcomes on Radiation Therapy Oncology Group (RTOG) 9406, a three-dimensional conformal radiation therapy (3D-CRT) dose escalation trial for localized adenocarcinoma of the prostate. Methods and Materials: RTOG 9406 is a Phase I/II multi-institutional dose escalation study of 3D-CRT for men with localized prostate cancer. Patients were registered on five sequential dose levels: 68.4 Gy, 73.8 Gy, 79.2 Gy, 74 Gy, and 78 Gy with 1.8 Gy/day (levels I-III) or 2.0 Gy/day (levels IV and V). Neoadjuvant hormone therapy (NHT) from 2 to 6 months was allowed. Protocol-specific, American Society for Therapeutic Radiation Oncology (ASTRO), and Phoenix biochemical failure definitions are reported. Results: Thirty-four institutions enrolled 1,084 patients and 1,051 patients are analyzable. Median follow-up for levels I, II, III, IV, and V was 11.7, 10.4, 11.8, 10.4, and 9.2 years, respectively. Thirty-six percent of patients received NHT. The 5-year overall survival was 90%, 87%, 88%, 89%, and 88% for dose levels I-V, respectively. The 5-year clinical disease-free survival (excluding protocol prostate-specific antigen definition) for levels I-V is 84%, 78%, 81%, 82%, and 82%, respectively. By ASTRO definition, the 5-year disease-free survivals were 57%, 59%, 52%, 64% and 75% (low risk); 46%, 52%, 54%, 56%, and 63% (intermediate risk); and 50%, 34%, 46%, 34%, and 61% (high risk) for levels I-V, respectively. By the Phoenix definition, the 5-year disease-free survivals were 68%, 73%, 67%, 84%, and 80% (low risk); 70%, 62%, 70%, 74%, and 69% (intermediate risk); and 42%, 62%, 68%, 54%, and 67% (high risk) for levels I-V, respectively. Conclusion: Dose-escalated 3D-CRT yields favorable outcomes for localized prostate cancer. This multi-institutional experience allows comparison to other experiences with modern radiation therapy. © 2012 Elsevier Inc. All rights reserved.


Michalski J.M.,University of Washington | Bae K.,Radiation Therapy Oncology Group | Roach M.,University of California at San Francisco | Markoe A.M.,University of Miami | And 6 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2010

Purpose: To update the incidence of late toxicity of RTOG 9406, a three-dimensional conformal radiation therapy (3DCRT) dose escalation trial for prostate cancer. Methods and Materials: A total of 1,084 men were registered to this Phase I/II trial of 3DCRT (eligible patients, 1,055). The dose for level I was 68.4 Gy; 73.8 Gy for level II; 79.2 Gy for level III; 74 Gy for level IV; and 78 Gy for level V. Patients in levels I to III received 1.8 Gy/fraction, and those in levels IV to V received 2.0 Gy/fraction. Disease group I patients were treated at the prostate only, group 2 patients were treated at the prostate and at the seminal vesicles with a prostate boost, and group 3 patients were treated at the prostate and seminal vesicles. The median follow-up period for surviving patients was 6.1 y (level V) to 12.1 y (level I). Results: The incidence rates of RTOG grade 3 or less gastrointestinal or genitourinary toxicity were 3%, 4%, 6%, 7%, and 9% in group 1 and 6%, 2%, 6%, 9%, and 12% in group 2 at dose levels of I, II, III, IV, and V, respectively. In group 1, level V patients had a higher probability of grade2 late or greater gastrointestinal or genitourinary toxicity than those in levels I, II, and III (hazard ratio [HR] = 1.93, p = 0.0101; HR = 2.29, p = 0.0007; HR = 2.52, p = 0.0002, respectively). In group 2, dose level V patients had a higher probability of grade 2 or greater late gastrointestinal or genitourinary toxicity than those in dose levels II, III, and IV (HR = 2.61, p = 0.0002; HR = 2.22, p = 0.0051; HR = 1.60, p = 0.0276, respectively). Conclusions: Tolerance to high-dose 3DCRT remains excellent. There is significantly more grade 2 or greater toxicity with a dose of 78 Gy at 2 Gy/fraction than with 68.4 Gy to 79.2 Gy at 1.8 Gy/fraction and with 74 Gy at 2 Gy/fraction. © 2010 Elsevier Inc. All rights reserved.


Hsu I.-C.,University of California at San Francisco | Hunt D.,Statistical Center | Straube W.,Image Guided Therapy Center | Pouliot J.,University of California at San Francisco | And 3 more authors.
Practical Radiation Oncology | Year: 2014

Purpose: Radiation Therapy Oncology Group 0321 is the first multi-institutional cooperative group high-dose-rate (HDR) prostate brachytherapy trial with complete digital brachytherapy dosimetry data. This is a descriptive report of the data and an analysis of toxicity. Methods and Materials: Patients are treated with external beam radiation therapy at 45 Gy and 1 HDR implant with 19 Gy in 2 fractions. Implants are done with transrectal ultrasound guidance, and computed tomography (CT)-compatible nonmetallic catheters. HDR planning is done on ≤. 3-mm-thick CT slices. The "mean DVH" (dose-volume histogram) of the planning target volume (PTV), implanted volume (IP), and organs at risk are calculated. This includes the mean and standard deviation (SD) of the volume at 10-percentage-point intervals from 10% to 200% of the prescribed dose. The conformal index (COIN), homogeneity index (HI), catheters per implant, and patients per institution are calculated. Multivariate analysis and hazard ratios calculation of all the variables against reported grade ≥. 2 (G2. +) genitourinary (GU) adverse events (Common Terminology Criteria for Adverse Events, version 3) are performed. Results: Dosimetry data are based on 122 eligible patients from 14 institutions. The mean of PTV, IP, catheters per implant, and patients per institution are 54 cc, 63 cc, 19 and 9, respectively. The mean of %V100PTV, V80Bladder, V80Rectum, and V120Urethra were 94%, 0.40 cc, 0.15 cc, and 0.25 cc, respectively. There are too few G2+ gastrointestinal adverse event (GI AE) for correlative analysis; thus, the analysis has been performed on the more common G2+ GU AE. There are positive correlations noted between both acute and late G2+ GU AE and urethral dose at multiple levels. Positive correlations with late AE are seen with PTV and IP at high-dose levels. A negative correlation is seen between HI and acute AE. A higher patient accrual rate is associated with a lower rate of G2+ acute and late AE. Conclusions: Higher urethral dose, larger high-dose volumes, and lower dose homogeneity are associated with greater toxicities. A mean dose-volume histogram comparison at all dose levels should be used for quality control and future research comparison. © 2014.


Santanam L.,University of Washington | Hurkmans C.,Catharina Hospital | Mutic S.,University of Washington | Van Vliet-Vroegindeweij C.,Thomas Jefferson University | And 7 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2012

Purpose: The aim of this study was to report on the development of a standardized target and organ-at-risk naming convention for use in radiation therapy and to present the nomenclature for structure naming for interinstitutional data sharing, clinical trial repositories, integrated multi-institutional collaborative databases, and quality control centers. This taxonomy should also enable improved plan benchmarking between clinical institutions and vendors and facilitation of automated treatment plan quality control. Materials and Methods: The Advanced Technology Consortium, Washington University in St. Louis, Radiation Therapy Oncology Group, Dutch Radiation Oncology Society, and the Clinical Trials RT QA Harmonization Group collaborated in creating this new naming convention. The International Commission on Radiation Units and Measurements guidelines have been used to create standardized nomenclature for target volumes (clinical target volume, internal target volume, planning target volume, etc.), organs at risk, and planning organ-at-risk volumes in radiation therapy. The nomenclature also includes rules for specifying laterality and margins for various structures. The naming rules distinguish tumor and nodal planning target volumes, with correspondence to their respective tumor/nodal clinical target volumes. It also provides rules for basic structure naming, as well as an option for more detailed names. Names of nonstandard structures used mainly for plan optimization or evaluation (rings, islands of dose avoidance, islands where additional dose is needed [dose painting]) are identified separately. Results: In addition to its use in 16 ongoing Radiation Therapy Oncology Group advanced technology clinical trial protocols and several new European Organization for Research and Treatment of Cancer protocols, a pilot version of this naming convention has been evaluated using patient data sets with varying treatment sites. All structures in these data sets were satisfactorily identified using this nomenclature. Conclusions: Use of standardized naming conventions is important to facilitate comparison of dosimetry across patient datasets. The guidelines presented here will facilitate international acceptance across a wide range of efforts, including groups organizing clinical trials, Radiation Oncology Institute, Dutch Radiation Oncology Society, Integrating the Healthcare Enterprise, Radiation Oncology domain (IHE-RO), and Digital Imaging and Communication in Medicine (DICOM). © 2012 Elsevier Inc.

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