Standarddose versus highdose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage iiia or iiib nonsmallcell lung cancer rtog 0617. This study aimed to evaluate the feasibility of using a singleinstitution, knowledgebased planning kbp model as a dosimetric plan quality control qc for multiinstitutional clinical trials. Nrg oncology rtog 0617 was open to accrual from november 2007 through november 2011. The study details of nrg oncology clinical trial rtog 0617 were reported in the primary outcome manuscript. The commonly accepted radiation therapy dose 6063 gy in 1820 gy fraction sizes for patients with stage iii nonsmallcell lung cancer was established by the radiation therapy oncology group rtog 7301 trial and has remained unchanged for more than 30 years. Regards, treena rtog 0617 newsletter june july 2010. Multiinstitutional validation of a knowledgebased planning. The prognosis for patients with localized ec has improved significantly with the advent of preoperative concurrent chemoradiotherapy ccrt, which confers 5year overall survival os rates of up to 47% 1,2, and definitive ccrt has been accepted as standard therapy for. Radiation and chemotherapy with or without an experimental drug rad001 your doctor may recommend this study following surgery for a high grade primary brain cancer glioblastoma rtog 0925. Jun 14, 2019 damage to the brachial plexus can arise following surgery or radiation. This study is a secondary analysis of the data compiled from nrgrtog 0617 to compare the use of imrt and 3d crt in patients with lung cancer.
Rtog 0617 cdr0000564240 ncctgn0628 calgb30609 nci201762 registry identifier. Rtog 0617ncctg n0628calgb 30609ecog r0617, a randomized phase. Early tumor and nodal response in patients with locally advanced nonsmall cell lung. Patients were randomly assigned to receive highdose 74 gy in 37 fractions or standard dose 60 gy in 30 fractions radiotherapy concurrently with weekly paclitaxel and carboplatin with or without cetuximab. We want to know your view of how your life has been affected by cancer. October 29, 2010 1818 market street, suite 1600 includes amendments 17.
Radiation therapy oncology group 0617 randomized patients with nonsmallcell lung cancer to receive 60 or 74gy radiation therapy 12. The pctv1 treatment dosage was 6066 gy, while the per fraction doses was 1. Radiation induced brachial plexopathy ribp is a late toxicity that can present months to years following a course of radiotherapy 2. Recently several stereotactic body radiation therapy sbrt lung protocols have been developed.
Rtog 0617 was initiated at a time when it was not standard of care to perform molecular analysis on tumor specimens in such patients. This study is a secondary analysis of the data compiled from nrg rtog 0617 to compare the use of imrt and 3d crt in patients with lung cancer. A randomized phase iii clinical trial evaluating postmastectomy chestwall and regional nodal xrt and postlumpectomy regional nodal xrt in patients with positive axillary nodes before neoadjuvant chemotherapy who convert to pathologically negative axillary nodes after neoadjuvant chemotherapy. The intergrouprtog 8501 concurrent chemoradiation regimen for japanese esophageal cancer article pdf available in hepatogastroenterology 5372. Nctn clinical trial standardization for radiotherapy. The management of potentially resectable stage iii nonsmall cell lung carcinoma nsclc is controversial.
In the lancet oncology, jeffrey bradley and colleagues1 report a randomised controlled trial of chemoradiotherapy for patients with stage iii nonsmallcell lung cancer. Nsclccetuximab the cancer imaging archive tcia public. Sep 24, 2012 considering the proportion of local recurrence was similar to the olcsg 0007 trial, a better strategy to control local relapse is a key to improving survival in locally advanced nsclc. A collection typically includes studies from several subjects patients. October 29, 2010 1818 market street, suite 1600 includes. Collections the cancer imaging archive tcia public.
Pelvic irradiation with concurrent chemotherapy versus pelvic. Radiation therapy with or without cetuximab in treating. The rtog 0617 study randomized patients to standard. Comparison of rtog 0618, 08, 0915, and accuray stars sbrt lung protocols purpose. Damage to the brachial plexus can arise following surgery or radiation. Definitive chemoradiotherapy is a core treatment modality for patients with stage iii non.
Our trial rtog 0617 was designed to establish whether a 74 gy dose was better than a 60 gy. In some collections, there may be only one study per subject. 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. Mild tightness of skin and itching may occur to promote hydrated skin, patient comfort and maintain skin integrity. The efficacy of this qc tool was retrospectively evaluated using a subset of plans submitted to radiation therapy oncology group rtog study 0617. Secondary analysis of nrg oncologyrtog 0617 pmid 28034064, pmid 28068179 impact of intensitymodulated radiation therapy technique for locally advanced nonsmallcell lung cancer. Regards, treena rtog 0617 newsletter september 2009. Conclusions patient reported outcomes are comparable between arms, supporting value based care with hf for low risk prostate cancer. A randomized, doubleblinded, placebocontrolled phase iii trial to evaluate the effectiveness of a phosphodiesterase 5 inhibitor, tadalafil, in prevention of erectile dysfunction in patients treated with radiotherapy for prostate cancer.
This planning study evaluated a stereotactic boost after concurrent chemoradiotherapy 30. In 1985, the radiation therapy oncology group rtog launched rtog 8501, a prospective, randomized, phase 3 trial testing the hypothesis that concurrent chemoradiotherapy followed by adjuvant chemotherapy could improve the overall survival rate of patients who had carcinoma of the thoracic esophagus without evidence of distant disease. Dec 15, 2018 this study aimed to evaluate the feasibility of using a singleinstitution, knowledgebased planning kbp model as a dosimetric plan quality control qc for multiinstitutional clinical trials. Chemoradiotherapy of locally advanced esophageal cancer. Revised ctep action letteraccrual is not suspended important information for rtog 0436, 0617, and 0920. Radiation therapy is a critical component in the care of patients with esophageal cancer ec. It was sponsored by ncis radiation therapy oncology group rtog under study number rtog0617. Recently published results from the longterm followup of radiation therapy oncology group rtog trial 9802 demonstrated medically meaningful and statistically significant survival prolongation. Considering the proportion of local recurrence was similar to the olcsg 0007 trial, a better strategy to control local relapse is a key to improving survival in locally advanced nsclc. Epidermal growth factor receptor egfr mutation analysis was not necessary for trial entry, and tissue was available for subsequent egfr hscore testing see sidebar on page 23 in less than 50% of accrued patients. And based on rtog 0324, the large phase iii rtog 0617 study of 419 patients was planned, with 237 patients receiving cetuximab bradley et al. Tsao said this is the trial that it is hoped will be used as the basis for the drug receiving approval for stage iii nsclc. Rtog 0617 was a phase iii randomized trial that compared a standard radiation therapy dose of 60 gy in 30 fractions with a higher dose of 74 gy in 37 fractions for patients receiving concurrent chemotherapy with or without cetuximab for inoperable stage iii lung cancer.
Nrg oncologyrtog 0415, phase iii noninferiority study. Standarddose versus highdose conformal radiotherapy with. 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. Exploring spatial overlap of highuptake regions derived. Sorafenib tosylate with or without stereotactic body. Patients were randomly assigned to receive highdose 74 gy in 37 fractions or standard dose 60 gy in 30 fractions radiotherapy concurrently with weekly paclitaxel and carboplatin with or without cetuximab, followed by. Radiation therapy oncology group rtog 0617ncctg n0628calgb 30609ecog r0617 a randomized phase iii comparison of standard dose 60 gy versus highdose 74 gy conformal radiotherapy with concurrent and.
Nrgalias broadcasts rtog clinical trials protocol table. A phase iii dose intensification study using three dimensional conformal radiation therapy and concurrent chemotherapy for patients with inoperable, nonsmall cell lung cancer objective. When response rates were evaluated, the proportion of patients with a complete or partial response in our series was similar to the proportions in other works. Impact of intensitymodulated radiation therapy technique. Attached please find the 0617 newsletter for the months of june and july. Current use of any organic nitrate or as needed nitrates e. Radiation therapy oncology group rtog 0618 a phase ii trial.
That trial has completed accrual, and the results from the cetuximab comparison are. Prognosis of locally advanced nonsmall cell lung cancer remains poor despite chemoradiation. Nrg rtog 0617 was a large, multiinstitutional phase iii, randomized clinical trial of patients with locallyadvanced nonsmall cell lung cancer nsclc conducted from 2007 to 2011. Pelvic irradiation with concurrent chemotherapy versus. Sep 18, 2019 data supporting preoperative chemoradiation in patients with gastric cancer, in the form of institutional and phase 2 cooperative group studies, have been reported. A secondary analysis of the nrg oncology rtog 0617 randomized clinical trial. The rtog 0617 trial involved 464 patients with stage iii nonsmallcell lung cancer nsclc, and compared highdose 74 gy with standarddose 60 gy radiation. Chang, md, phd md anderson cancer center md anderson cancer center 1515 holcombe blvd. Pdf the intergrouprtog 8501 concurrent chemoradiation. Radiation oncologyrtog trials0117 wikibooks, open books. Combinedmodality field changing for advanced disease. Radiation therapy oncology group rtog 0617 ncctg n0628calgb 30609ecog r0617 a randomized phase iii comparison of standard dose 60 gy versus highdose 74 gy conformal radiotherapy with concurrent and. Radiation therapy with or without cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Higher versus standard preoperative radiation in the. No trial has compared the outcomes of induction chemoradiation using different radiation doses. Although radiotherapy rt technologies have advanced dramatically, to the authors knowledge relatively little is known regarding the importance of irradiation technique on outcome, particularly given the competing risk of distant metastasis. The authors suggest that the poorer results with 74 gy are likely due to a combination of. The rtog 0225 and rtog 0615 protocols for npc provided good treatment outcomes and acceptable rtrelated toxicities in patients from the nonendemic regions 12. Jan 07, 20 recently published results from the longterm followup of radiation therapy oncology group rtog trial 9802 demonstrated medically meaningful and statistically significant survival prolongation. Options include induction chemotherapy or induction chemoradiation followed by resection, or chemoradiation without surgery. The maximum achievable boost directed to radioresistant primary tumor subvolumes based on pretreatment fluorine18 fluorodeoxyglucose positron emission. Radiation therapy oncology group rtog 0617 ncctg n0628calgb 30609ecog r0617 a randomized phase iii comparison of standard dose 60 gy versus highdose 74 gy.
Ctrp clinical trial reporting program u10ca021661 u. Secondary analysis of nrg oncology rtog 0617 pmid 28034064, pmid 28068179 impact of intensitymodulated radiation therapy technique for locally advanced nonsmallcell lung cancer. Lung cancer patients who receive intensity modulated. In other collections, subjects may have been followed over time, in which case there will be multiple studies per. The maximum achievable boost directed to radioresistant primary tumor subvolumes based on pretreatment fluorine18 fluorodeoxyglucose positron emission tomographycomputed. Attached please find the 0617 newsletter for the month of september.
The radiation dose tolerance of the brachial plexus. Stereotactic radiotherapy boost after definite chemoradiation. Iroc has evaluated and established the feasibility of automated qa of cardiac structures using the atlases created from rtog 0617. 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.
Influence of conformal radiotherapy technique on survival. Rtog 08 seamless phase iii study of stereotactic lung. University of texas southwestern 5801 forest park road, nf3. Heart and lung doses are independent predictors of overall. A randomized phase iii comparison of standard dose 60 gy versus highdose 74 gy conformal radiotherapy with concurrent and consolidation. All patients had histologically proven nsclc and had american joint committee on cancer stage iiia or iiib disease with zubrod performance status 0 to 1. For npc, the prescription dose was in accordance with the regulations of the rtog 0615 and rtog 0225. Novel approaches of chemoradiotherapy in unresectable. Data supporting preoperative chemoradiation in patients with gastric cancer, in the form of institutional and phase 2 cooperative group studies, have been reported. Radiation oncologynsclclocally advanced unresectable. Ede100 image interpretation exhibit in digital format education exhibits location.
The image data in the cancer imaging archive tcia is organized into purposebuilt collections. The prognosis for patients with localized ec has improved significantly with the advent of preoperative concurrent chemoradiotherapy ccrt, which confers 5year overall survival os rates of up to 47% 1,2, and definitive ccrt has been accepted as standard therapy for patients with inoperable. Pathological confirmed that nsclc patients were eligible. Rtog is funded by national cancer institute grant numbers. Collections the cancer imaging archive tcia public access. Your doctor may recommend this study if you have a lowgrade primary brain cancer. Brachial plexopathy manifests clinically as neuropathic pain, paresthesias, or motor weaknesses of the upper extremities, and can cause significant morbidity 1. Nrg oncology radiation therapy oncology group rtog 0617. You will need adobe acrobat reader to read the attached pdf document. In calgb 39808, although pneumonitis was not specifically mentioned, 5% of the patients developed grade 3 or higher dyspnea none in the current study, 23 and this is similar to the 2% to 3% in the interim results of the convert study. Ctrp clinical trials reporting program first posted. Nrgrtog 0617 was a large, multiinstitutional phase iii, randomized clinical trial of patients with locallyadvanced nonsmall cell lung cancer nsclc conducted from 2007 to 2011. 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.
The rtog 0617 trial, just published online first in lancet oncology, echoes this same theme, this time clearly refuting a widespread presumption that a higher dose of chest radiation therapy. Exploring spatial overlap of highuptake regions derived fro. Nothing to disclose teaching points this is the companion electronic exhibit to the image interpretation session, scheduled for sunday, november 30, 4. A recent report with a median of 23 months of followup noted a lower overall survival in the 74gy cohort 12. Bms, imclone andor nci safety reports for cetuximab.