Supported by an independent educational grant from astrazeneca. Rtog 08, amended amended rtog 08, seamless phase iii study of stereotactic lung radiotherapy sbrt for early stage, centrally located, nonsmall cell lung cancer nsclc in medically inoperable patients, amendment 1. To evaluate the efficacy and outcomes of hypofractionated stereotactic radiotherapy hsrt for brain metastases 3 cm. Randomized, double blinded phase iii trial of cisplatin. Hsrt was applied in 29 patients for primary treatment and in 11 patients for rescue. Not an official event of the 2016 asco annual meeting. Dosemodeling study to compare external beam techniques. Contouring guidelines for carcinoma cervix 3dcrtimrt ctv n. Pdf the intergrouprtog 8501 concurrent chemoradiation. Rutgers cancer institute of new jersey 195 little albany street new brunswick, nj 089032681 732235cinj 2465. Progress in the management of limitedstage small cell. Purpose patients with centrally located earlystage nonsmallcell lung cancer nsclc are at a higher risk of toxicity from highdose ablative radiotherapy. Compliance with protocol radiosurgery was determined by assessing coverage of the target volume by the prescription isodose line on serial axial images from the treatment planning scan. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Each trial has a person in charge, usually a doctor, who is called the protocol chair or principal investigator also called the pi. Primary tumor control is defined as the absence of primary tumor failure. From march 2003 to october 2009, 40 patients with brain metastases larger than 3 cm were treated by hsrt. Arm ii patients undergo intensitymodulated radiation therapy imrt 5. Longterm clinical outcomes and safety profile of sbrt for. Hypofractionated stereotactic radiotherapy for brain. Rtog 0538calgb 30610 protocol student doctor network. Coverage was scored as acceptable no deviation from the protocol, minor deviation marginal coverage of the tumor volume, or major deviation partial miss of. Listing a study does not mean it has been evaluated by the u. However, some men with newly diagnosed prostate cancer have a more extensive primary tumor t2b or higher, regional lymph node metastases n1, or other factors associated with an increased risk of local recurrence or progression to disseminated disease serum prostatespecific antigen. Randomized, double blinded phase iii trial of cisplatin and etoposide plus thoracic radiation therapy followed by nivolumabplacebo for locally advanced nonsmall cell lung cancer. Calgb 9761 pmid 15829324 poor correspondence between clinical and pathologic staging in stage i nonsmall cell lung cancer. The intergrouprtog 8501 concurrent chemoradiation regimen for japanese esophageal cancer article pdf available in hepatogastroenterology 5372. Rtog 08 seamless phase iii study of sbrt for early stage, centrally located, nonsmall cell lung cancer in medically operable patients rtog 0236 has something for everyone anatomy definition oar constraints guidance for physicists other documents astroaans consensus statement on stereotactic radiosurgery quality improvement, 1993.
It is intended to be used only in conjunction with institutionspecific irb approval for study entry. Rtog 08 seamless phase iii study of stereotactic lung. The dose compliance criteria for current protocols, e. Protocol summary rtog 0938 hypofractionated radiotherapy for. We are a leading protocol organizations within the national clinical trials network and we seek to.
Involved nodes gtv n and relevant draining nodal groups common iliac, external iliac, internal iliac, obturator and pre sacral lymph nodes ctv primary ctvp includes gtv primary, uterine cervix, uterine corpus, parametrium, vagina and ovaries total ctv. Stereotactic body radiation therapy in treating patients. Request pdf dosemodeling study to compare external beam techniques from protocol nsabp b39rtog 04 for patients with highly unfavorable cardiac anatomy the aim of this study was to select. Irbs exist at most hospitals to help safeguard patient rights. Trog cancer research are dedicated to improving the quality of life for australian cancer patients with world class radiotherapy research. Nsabp protocol b39 rtog protocol 04 a randomized phase iii study of conventional whole breast irradiation wbi versus partial breast irradiation pbi for women with stage 0, i, or ii breast cancer national surgical adjuvant breast and bowel project nsabp. Rtog 08 seamless phase iii study of stereotactic lung radiotherapy sbrt for early stage, centrally located nonsmall cell lung cancer nsclc in medically inoperable patients principal investigator. If you would like to utilize this site to register a patient and have not been assigned a login name and password from nrgrtog headquarters, please access the password. Clinical trials system american college of radiology.
This protocol was designed and developed by the radiation therapy oncology. Dosimetric verification using monte carlo calculations for tissue. The incidence of all types of lung cancer, including sclc, has been declining in the united. Primary study endpoint analysis of nrg oncologyrtog 08 trial. This site will allow users to register a patient or enter case form data directly to a nrgrtog study twentyfour 24 hours a day, seven 7 days a week. Radiation therapy oncology group rtog 09 is an ongoing phase iiir study combining daily everolimus with concurrent radiation and temozolomide. Rtog 08 seamless phase iii study of stereotactic lung radiotherapy sbrt for early stage, centrally located nonsmall cell lung cancer nsclc in medically inoperable patients author. Rtog 08, version date june 8, 2015 rtog 08 title page continued 8712 senior statistician consulting statistician chen hu, phd daniel normolle, phd nrg oncology university of pittsburghupci biostatistics facility 1818 market street, suite 1720 201 n.
Not sponsored or endorsed by asco or the conquer cancer foundation. Nrg oncology rtog 08 was a phase iii study designed to determine the maximum tolerated dose mtd, efficacy, and toxicity of stereotactic body radiotherapy sbrt for centrally located nsclc. No other use or reproduction is authorized by rtog nor does rtog assume any responsibility for. Single brain metastasis was detected in 21 patients. However, a significant number of patients will receive a diagnosis of sclc, and approximately 40% of patients with sclc will have limitedstage ls disease, which is potentially curable with the combination of chemotherapy and radiation therapy.
Implementation of radiosurgery and sbrt requires a. Primary tumor failure ptf refers to the primary treated tumor after protocol therapy and corresponds to meeting following two criteria. Chemotherapy plus radiation therapy in treating patients. Arm i patients undergo standard 3dimensional radiation therapy 5 days a week for up to 5. Memory hvltr dr memantine reduced the decline in hvltr dr by 0. The site also will report the adverse event via adeers see section 6. These were compared to constraints from the rosel and rtog 08 clinical trials. The hospital of central connecticut a seamless phase iii study of stereotactic lung radiotherapy sbrt for early stage, centrally located nonsmall cell lung cancer nsclc in medically inoperable patients.
Craig streetsterling plaza, suite 325 philadelphia, pa 19103 pittsburgh, pa 152. We are a leading protocol organizations within the national clinical trials network and we seek to improve the lives of cancer patients by conducting. The protocol was originally designed to include 6 cycles of adjuvant chemotherapy, but it was amended to 4 cycles november, 2000 because of findings from a published study that patients had difficulty tolerating a 6cycle regimen of gemcitabine and cisplatin, as evidenced by grade 3 and 4 hematologic toxicities neutropenia and. Group 101 report and protocol guidelines from rtog. This protocol was designed and developed by the radiation therapy oncology group rtog of the american college of radiology acr. Dosimetric verification using monte carlo calculations for. Radiation is delivered using intensity modulated radiation therapy imrt or 3dimensional 3dconformal radiation 60 gy in 30 fractions of 2 gy each. All sites must fax the treatment chart t5 to rtog headquarters 2159408831. Prostate cancer is increasingly diagnosed in younger men and at an earlier disease stage. Sbrt conformal treatment plans were generated using xio cms inc. Looks like it has been removed from the rtog website. Poorer than expected survival led to poor protocol compliance 149 patients analyzable at 24 weeks primary objective. Chemotherapy plus radiation therapy in treating patients with stage ii or stage iii anal cancer. A phase iii trial comparing whole brain irradiation with versus without stereotactic radiosurgery boost for patients with one to three unresected brain metastases arm 1.
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