The radiation therapy oncology group has completed 2 trials rtog 0614 and 0933 aimed at reducing the toxicity of wbrt. Phase 2 results author links open overlay panel samuel ryu md a stephanie l. Nrg oncology rtog 6 a randomized phase ii study of. If such tumorselective dose reduction could convert 24 gy tumor cure to a. Oct 21, 2016 we would like to thank the nrg oncology rtog staff including minhee won, kathryn okrent, sandrine geinoz, barbara kaiser, and denise manfredi for their outstanding work on this clinical trial. Clinical trials open at rapid city regional hospital. The rtog 0631 phase ii results demonstrate the feasibility and early safety of performing single fraction imageguided srs with rigorous qa in a cooperative group setting, and support proceeding with the planned phase iii component to compare pain relief and quality of life between 16 gy or 18 gy single fraction srs and 8 gy single fraction. Galvin, dsc thomas jefferson university hospital jefferson medical college philadelphia, pa and the radiation therapy oncology group 2008 aapm annual meeting houston, tx radiation therapy oncology group rtog 0236 phase ii trial of stereotactic body radiation therapy sbrt in the. Phase ii results the phase ii component of rtog 0631 assessed the. Kane iii, md medical college of wisconsin roswell park cancer institute. Documents provided by radiation therapy oncology group.
Phase iii randomized study of concurrent chemotherapy and. From wikibooks, open books for an open world pdf ongoing breast phase ii. A phase iii randomized trial of whole brain radiation therapy wbrt in addition to radiosurgery srs in patients with 1 to 3 brain metastases anyone heard about this study. May 16, 2016 nrg oncology rtog 6 a randomized phase ii study of individualized combined modality therapy for stage iii nonsmall cell lung cancer nsclc. Radiation oncologyrtog trials wikibooks, open books for an. Schematic illustration of the phase 23 designed radiation therapy oncology group rtog 0631 study of spine. Sep 10, 2014 issuu is a digital publishing platform that makes it simple to publish magazines, catalogs, newspapers, books, and more online. Quality control for the use of igrt in clinical trials james m.
Strategies to mitigate toxicities from stereotactic body. These scanners now come with nuance powerpdf standard software for windows and nuance pdf converter software for mac. Treatment planning skills that a physicist should know. We follow rtog 08 and rtog 0915 lung protocols criteria for ptv coverage, high dose spillage and dose fall off. Breast cancer many studies show that toxicities were associated with dose inhomogeneity both acute and long term toxicities such as moist desquamation, pain, breast discomfort and breast hardness randomized clinical trials. Fillable pdf forms and additional information can be found on the ctep website at. Rtog 0631 phase 23 study of image guided stereotactic. The rtog 0225 and rtog 0615 protocols for npc provided good treatment outcomes and acceptable rtrelated toxicities in patients from the nonendemic regions 12. The phase 2 component of radiation therapy oncology group rtog 0631 assessed the feasibility and safety of spine radiosurgery srs for localized spine metastases in a cooperative group setting. Imageguided radiosurgery or stereotactic body radiation.
The spine phantom is a water filled thorax with anatomy encountered in spinal radiosurgery. Determine the feasibility of successfully delivering imageguided radiosurgery or stereotactic body radiotherapy sbrt in patients with spine metastases in a cooperative group setting. Implementation of radiosurgery and sbrt requires a. Many more patients are enrolled in clinical trials sponsored by other groups. Pts with biopsy proven peripheral t1t3, n0, m0 tumors were eligible. Rtog 0631 radiation therapy oncology group rtog 0631 phase iiiii study of imageguided radiosurgerysbrt for localized spine metastasis study chairs principal investigatorradiation oncology samuel ryu, md henry ford hospital 2799 w. Concurrent oncedaily versus twicedaily chemoradiotherapy. Common terminology criteria for adverse events ctcae. Clinical trials at cdrp sites national cancer institute. Rtog 0614 was a randomized trial of wbrt versus wbrt and memantine in patients with brain metastases and showed better cognitive function over time in the memantine group. Mar 11, 2008 radiation therapy uses highenergy xrays to kill tumor cells. Clinical trial finds no difference in pain response. Radiation therapy regimens in treating patients with limited.
Sixtyfive institutions were credentialed with spine phantom dosimetry and igrt compliance. Kane iii, md medical college of wisconsin roswell park cancer. Commissioning an anthropomorphic spine and lung phantom. However, it is imperative to apply these protocols to patients from the areas of china where npc is endemic, and further assess longterm survival and late toxicities. Dosimetric evaluation of heterogeneity corrections for rtog 0236. This is a pdf file of an unedited manuscript that has been accepted for publication. The phase ii component of rtog 0631 assessed the feasibility and safety of spine radiosurgery srs for localized spine metastases in a cooperative group setting. Pelvic irradiation with concurrent chemotherapy versus pelvic. Randomized phase iiiii trial of surgery and postoperative radiation delivered with concurrent cisplatin versus docetaxel versus docetaxel and cetuximab for highrisk squamous cell cancer of the head and neck.
Rtog 0631 phase 23 study of image guided stereotactic radiosurgery for localized. Radiation therapy oncology group rtog 0618 a phase ii trial of stereotactic body radiation therapy sbrt in the treatment of patients with operable stage iii nonsmall cell lung cancer study chairs 2409 principal investigatorradiation oncologyigrt robert d. Patients with spine metastasis with a numerical rating pain scale nrps score 5 received 16 gy single. Rtog 0631 phase 23 study of image guided stereotactic radiosurgery for localized spine metastases.
We are a leading protocol organizations within the national clinical trials network and we seek to improve the lives. If you have questions about md andersons appointment process, our information page may be the best place to start. Nctn gastrointestinal cancer trials portfolio open as of 3162020 each far right box includes the nctn protocol number with a hyperlink to the associated clinicaltrials. Assessment observation effects of radiotherapy on skin cells rationale rtog 0 no visible. Intermediate risk prostate cancer may be well controlled with. The treatment of spine metastases per the rtog 0631 pro tocol using. The radiation therapy oncology group rtog has previously studied various treatment fractionation regimens for palliation of bone metastases and found that shorter treatments were as effective as longer treatments in achieving pain relief 4. A pilot study of hypofractionated external beam radiation and hdr brachytherapy for advanced prostate cancer. Rtog 0631 phase iiiii study of imageguided radiosurgery. Clinical trials southeast radiation oncology group, p. Rtog 0631 is a multiinstitutional study, began in 2009, designed to show the clinical feasibility of sbrt for the. To investigate the treatment plan quality and adherence to radiation therapy oncology group rtog 0631 protocol for spine stereotactic radiosurgery srs planned for delivery on a magnetic resonance imaging guided linear accelerator mrlinac. Common terminology criteria for adverse events ctcae v5. Recently several stereotactic body radiation therapy sbrt lung protocols have been developed.
Ryu and others published rtog 0631 phase iiiii study of imageguided stereotactic radiosurgery for localized spine metastases. This site will allow users to register a patient or enter case form data directly to a nrg rtog study twentyfour 24 hours a day, seven 7 days a week. Clicking on the protocol number will provide access to the protocol specific web page which includes specific information including the protocol, study forms, and other study documents. Randomisedtrial of standard 2d radiotherapy rt versus intensity modulated radiotherapy imrt in patients. Rpc inhouse software was used to convert the optical density to dose.
Rtog 1016 phase iii trial of radiotherapy plus cetuximab. This study use the ptvs defined by the solid red line. Dose tolerance limits and dose volume histogram evaluation for. Clinical trials school of medicine university of louisville. Survival and toxicities of imrt based on the rtog protocols.
Rtog 0236 a phase ii trial of sbrt in the treatment of patients with medically inoperable stage iii nonsmall cell lung cancer rtog 0618 a phase ii trial of sbrt in the treatment of patients with operable stage iii nonsmall cell lung cancer rtog 08 seamless phase iii study of sbrt for early stage, centrally. Rtog 0630 radiation therapy oncology group rtog 0630 a phase ii trial of image guided preoperative radiotherapy for primary soft tissue sarcomas of the extremity study chairs principal investigatorradiation oncology surgical oncology cochair dian wang, md, phd john m. Normal tissue constraint guidelines the radiation dose constraints below are meant to serve as a guide only and may not be applicable to all clinical scenarios. Oct 01, 2011 rtog 0631 phase iiiii study of imageguided stereotactic radiosurgery for localized spine metastases. Since the trial was designed to show superiority of oncedaily radiotherapy and was not powered to show equivalence, the implication is that twice. Cureus investigation of srs spine treatment plan quality. This study assessed the phantoms dosimetric and anatomic utility. Patients with the following pathology findings may be treated with pelvic radiation with or without weekly cisplatin at the treating physicians discretion. Request pdf rtog 0631 phase iiiii study of imageguided stereotactic radiosurgery for localized spine metastases. Radiation therapy oncology group rtog, now part of nrg oncology, initiated a phase 23 study rtog 0631 to examine whether the higher biologically effective doses delivered with ssrs could lead to improved quality of life and pain control compared with. Click on it to view the protocol title and study information. Single fraction radiosurgerystereotactic body radiation. Bone is the most common metastatic site for cancer with the incidence of spinal metastases on postmortem studies estimated to be up to 70% in solid malignancies.
Imageguided radiosurgery or stereotactic body radiation therapy. The rpc developed a new phantom to ensure comparable and consistent radiation administration in spinal radiosurgery clinical trials. Two previously treated spine srs patients were replanned on a monte carlobased mrlinac. This trial was conducted by the radiation therapy oncology group rtog, and was supported by rtog grant u10 ca21661 and ccop grant u10 ca37422 from the national cancer institute nci. A prior radiation therapy oncology group rtog clinical trial in anaplastic oligodendroglioma suggested a progressionfree survival.
Looks like it has been removed from the rtog website. Page 1 of 3 rtog 0631 phase iiiii study of imageguided radiosurgerysbrt for localized spine metastasis principal investigator. Rpc inhouse software was used to convert the optical density to dose, and the film was then normalized to the tld results. In addition, we seek to determine whether the conversion of patients with. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Because statistically significant advantages for this experimental approach could not be defined for all end. Rtog 0631 study memorandum amendment 9 august 24, 2015.
Study protocol and statistical analysis plan pdf september 23, 2016. The decision to add weekly cisplatin for these patients is at the treating physicians discretion. Rtog 0631 phase iiiii study of imageguided stereotactic radiosurgery for localized spine metastases. The nci common terminology criteria for adverse events is a descriptive terminology which can be utilized for adverse event ae reporting. Nrg rtog 0631 was designed to compare two treatment options for patients with spinal metastases in one to three spinal sites. Sep 16, 2014 longterm results of rtog 0236 confirm good primary tumor control, positive fiveyear survival rates. Randomized trial of short versus longcourse radiotherapy. The phase ii component of rtog 0631 assessed the feasibility and safety of.
Dosimetric evaluation of heterogeneity corrections for rtog. Similarly to nrg study rtog 0631, disease in 2 contiguous vertebral bodies with up to 6 cm of paraspinal extension can represent one site of disease in the spine. Radiation therapy oncology group rtog 0618 a phase ii trial. The rtog 0631 prospective phase iii trial compares 8 gy with 16 gy in single. Rtog 4 ulceration, bleeding, necrosis rarely seen rtog assessment tool and intervention rationales please can you ensure that all patients on discharge are given one weeks supply of the dressings they are on. Lung, breast, prostate and colon cancers have the highest number of clinical trials dedicated to them more than 40 percent of the total number of trials. Secondary analysis of rtog 9508, a phase 3 randomized trial.
Comparison of rtog 0618, 08, 0915, and accuray stars sbrt lung protocols purpose. Calgb 30610 thoracic radiotherapy for limited stage small cell lung cancer. Calgb 30610 rtog 0538 limited small cell 45 gy bid 3 weeks 61. Survival outcomes did not differ between twicedaily and oncedaily concurrent chemoradiotherapy in patients with limitedstage smallcell lung cancer, and toxicity was similar and lower than expected with both regimens. Rtog 0631 study memorandum termination april 6, 2020. All pts were deemed operable by a thoracic surgeon utilizing specific criteria.
Calgb and convert critical test for dose escalation paradigm. The radiation therapy oncology group rtog protocol 0618 was a phase ii trial utilizing sbrt to treat early stage nonsmall cell lung cancer in operable patients pts. Physicians on this study were able to predict which patients would have longer survival times, although the prediction of survival was optimistic compared to actual survival by an average of 3. Commissioning an anthropomorphic spine and lung phantom for remote dose verification of institutions participating in rtog 0631. A singlefraction sbrt treatment plan was then developed for delivery using tomotherapy. To gain insight into the dose tolerance limits and the fractionation s chemes, this study is a comparison of the rtog 0618, 08, 0915, and accuray stars sbrt lung. Rtog 0631 phase iiiii study of imageguided stereotactic. Longterm results of rtog 0236 confirm good primary tumor. A phase ii trial to evaluate hdr brachytherapy as monotherapy for stage i and ii breast carcinoma. It is intended to be used only in conjunction with institutionspecific irb approval for study entry. However only a small number of patients were treated on these studies. Radiation oncologyrtog trials8531 wikibooks, open books.
Most doses are derived from randomized studies or consensus. Rtog 0631 for spine radiosurgery via knowledgebased planning, international journal of radiation oncology biology physics 2018, doi. No other use or reproduction is authorized by rtog nor does rtog assume any. This protocol was designed and developed by the radiation therapy oncology group rtog of the american college of radiology acr. Kps, fact scores, and physician predicted survival all are correlated with actual survival. Study chairs 41415 principal investigatorradiation oncology samuel ryu, md department of radiation oncology stony brook university school of medicine 101 nicolls road stony brook, ny 117947028. Rtog is funded by national cancer institute grant numbers. Clinical trials system american college of radiology. If you are ready to make an appointment, select a button on the right. Easily share your publications and get them in front of issuus. Conference series paper open access spine sbrt using vmat. For all spinal metastases, the partial spinal cord volume as per rtog 0631.
About 60 percent of the adults enrolled in clinical trials are women. Intermediate risk prostate cancer may be well controlled with brachytherapy alone initial report of large nrg oncology rtog 0232 study demonstrates effectiveness of prostate brachytherapy as a standalone modality for progression free survival boston, september 26, 2016 for men with intermediate risk prostate cancer, radiation treatment. A phase iii study comparing combined external beam radiation and transperineal interstitial permanent brachytherapy with brachytherapy alone for selected patients with intermediate risk prostatic carcinoma. Comparison of dose distribution in spine radiosurgery plans. Rtog 0631, sbrt, spine metastasis, srs this is an open access article under the terms of the creative commons attribution license, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. This project was supported by grants u10ca21661, u10ca180868, u10ca180822, u10ca37422, and u24ca180803 from the national cancer institute nci.
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