Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer
NCT ID: NCT03422198
Last Updated: 2025-12-12
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
188 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-02-02
Study Completion Date
2029-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This randomized phase III trial studies short course vaginal cuff brachytherapy to see how well it works compared with standard of care vaginal cuff brachytherapy in treating participants with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as internal radiation therapy, uses (over a shorter period) radioactive material placed directly into or near a tumor in the upper portion of the vagina to kill tumor cells.
After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.
After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer
NCT03189446
Endometrial Cancer
Papillary Serous
Clear Cell Endometrial Cancer
COMPLETED
PHASE2
Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer
NCT00807768
Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Fatigue
+4 more
UNKNOWN
PHASE3
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer
NCT00542490
Endometrial Cancer
Papillary Serous
Clear Cell Endometrial Cancer
COMPLETED
PHASE2
Frontline Immunotherapy Combined With Radiation and Chemotherapy in High Risk Endometrial Cancer
NCT03932409
Endometrial Cancer
ACTIVE_NOT_RECRUITING
PHASE1
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
NCT00005840
Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Stage III Uterine Corpus Cancer
+1 more
COMPLETED
PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Endometrial cancer is the most common gynecologic cancer in the Western world and primarily affects postmenopausal women. The primary form of treatment is surgery, consisting of a total abdominal or laparoscopic hysterectomy and bilateral salpingo-oophorectomy. Adjuvant radiotherapy for endometrial cancer has been studied in prospective trials for at least four decades. All trials have demonstrated an improvement in local regional control. However, improvement in survival has not been observed in prospective randomized trials in early-stage patients.
There is great heterogeneity in prognoses in stage I patients. National Comprehensive Cancer Network (NCCN) guidelines consequently recommend no treatment in general for low-stage patients, adjuvant brachytherapy for patients with intermediate- and high-intermediate-risk disease, and for patients with deeply invasive tumors with high-grade lesions, external beam radiotherapy is an option (NCCN Guidelines 2016). Over the ensuing decades, there has been a shift toward increasing use of vaginal cuff brachytherapy.
This is a phase III, unblinded, randomized trial comparing an experimental arm and a control arm of vaginal cuff brachytherapy: The experimental arm will treat subjects with 2 fractions of vaginal brachytherapy. The control arm will treat subjects with standard-of-care vaginal cuff brachytherapy of 3-5 fractions. Patients will be randomized 1:1 to the different treatment arms.
After completion of cohort 1 (108 participants), the protocol was expanded to add a second cohort of 80 additional participants, and reopened study recruitment.
Cohort 1 evaluated the non-inferiority of patient Health Related Quality of Life (HRQOL) in the experimental arm compared to the control arm using the Global Health Status from the EORTC QLQ-C30. Cohort 2 will evaluate the frequency and severity of patient-reported financial toxicity in patients with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one month post-VCB.
There is great heterogeneity in prognoses in stage I patients. National Comprehensive Cancer Network (NCCN) guidelines consequently recommend no treatment in general for low-stage patients, adjuvant brachytherapy for patients with intermediate- and high-intermediate-risk disease, and for patients with deeply invasive tumors with high-grade lesions, external beam radiotherapy is an option (NCCN Guidelines 2016). Over the ensuing decades, there has been a shift toward increasing use of vaginal cuff brachytherapy.
This is a phase III, unblinded, randomized trial comparing an experimental arm and a control arm of vaginal cuff brachytherapy: The experimental arm will treat subjects with 2 fractions of vaginal brachytherapy. The control arm will treat subjects with standard-of-care vaginal cuff brachytherapy of 3-5 fractions. Patients will be randomized 1:1 to the different treatment arms.
After completion of cohort 1 (108 participants), the protocol was expanded to add a second cohort of 80 additional participants, and reopened study recruitment.
Cohort 1 evaluated the non-inferiority of patient Health Related Quality of Life (HRQOL) in the experimental arm compared to the control arm using the Global Health Status from the EORTC QLQ-C30. Cohort 2 will evaluate the frequency and severity of patient-reported financial toxicity in patients with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one month post-VCB.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Endometrial Clear Cell Adenocarcinoma
Endometrial Endometrioid Adenocarcinoma
Endometrial Serous Adenocarcinoma
Stage I Uterine Corpus Cancer
Stage IA Uterine Corpus Cancer
Stage IB Uterine Corpus Cancer
Stage II Uterine Corpus Cancer
Uterine Corpus Carcinosarcoma
Uterine Corpus Sarcoma
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Short course vaginal cuff brachytherapy
Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
Group Type
EXPERIMENTAL
Short course vaginal cuff brachytherapy
Intervention Type
RADIATION
Undergo short course vaginal cuff brachytherapy
Vaginal cuff brachytherapy
Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
Group Type
ACTIVE_COMPARATOR
Vaginal Cuff Brachytherapy
Intervention Type
RADIATION
Undergo standard of care vaginal cuff brachytherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vaginal Cuff Brachytherapy
Undergo standard of care vaginal cuff brachytherapy
Intervention Type
RADIATION
Short course vaginal cuff brachytherapy
Undergo short course vaginal cuff brachytherapy
Intervention Type
RADIATION
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
best practice
standard of care
standard therapy
BRACHYTHERAPY
internal radiation
Internal Radiation Brachytherapy
Internal Radiation Therapy
Radiation Brachytherapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clear cell, to include tumors originating in the cervix, but are primarily located in the uterus, and for whom vaginal cuff brachytherapy is indicated. Carcinosarcoma and other sarcomas are permitted; Federation of Gynecology and Obstetrics (FIGO) stage I and stage II, with one of the following combinations of stage and grade:
* Stage IA, grade 1 with LVSI, 2, 3
* Stage IB, grades 1-3
* Stage II, grades 1-3
* Stage IIIA, grades 1-3, not receiving EBRT as part of adjuvant therapy.
* Participants post-hysterectomy and free from residual disease.
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance status 0-2.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
* Life expectancy of \>2 years.
* Stage IA, grade 1 with LVSI, 2, 3
* Stage IB, grades 1-3
* Stage II, grades 1-3
* Stage IIIA, grades 1-3, not receiving EBRT as part of adjuvant therapy.
* Participants post-hysterectomy and free from residual disease.
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance status 0-2.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
* Life expectancy of \>2 years.
Exclusion Criteria
* Stages of endometrial carcinoma other than described.
* Previous pelvic radiotherapy.
* Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.
* Previous pelvic radiotherapy.
* Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Huntsman Cancer Institute
OTHER
Sponsor Role
collaborator
University of Utah
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cristina DeCesaris, MD
Role: PRINCIPAL_INVESTIGATOR
Huntsman Cancer Institute/ University of Utah
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford Cancer Center
Palo Alto, California, United States
Site Status
COMPLETED
Loyola University Medical Center
Maywood, Illinois, United States
Site Status
RECRUITING
MD Anderson
Houston, Texas, United States
Site Status
RECRUITING
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Site Status
RECRUITING
Intermountain Medical Center / LDS Hospital
Salt Lake City, Utah, United States
Site Status
COMPLETED
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Pecorelli S. Revised FIGO staging for carcinoma of the vulva, cervix, and endometrium. Int J Gynaecol Obstet. 2009 May;105(2):103-4. doi: 10.1016/j.ijgo.2009.02.012. No abstract available.
Reference Type
BACKGROUND
Briet JM, Hollema H, Reesink N, Aalders JG, Mourits MJ, ten Hoor KA, Pras E, Boezen HM, van der Zee AG, Nijman HW. Lymphvascular space involvement: an independent prognostic factor in endometrial cancer. Gynecol Oncol. 2005 Mar;96(3):799-804. doi: 10.1016/j.ygyno.2004.11.033.
Reference Type
BACKGROUND
Cohn DE, Horowitz NS, Mutch DG, Kim SM, Manolitsas T, Fowler JM. Should the presence of lymphvascular space involvement be used to assign patients to adjuvant therapy following hysterectomy for unstaged endometrial cancer? Gynecol Oncol. 2002 Dec;87(3):243-6. doi: 10.1006/gyno.2002.6825.
Reference Type
BACKGROUND
Thomas GM. A role for adjuvant radiation in clinically early carcinoma of the endometrium? Int J Gynecol Cancer. 2010 Oct;20(11 Suppl 2):S64-6. doi: 10.1111/IGC.0b013e3181f5c688.
Reference Type
BACKGROUND
Bosse T, Peters EE, Creutzberg CL, Jurgenliemk-Schulz IM, Jobsen JJ, Mens JW, Lutgens LC, van der Steen-Banasik EM, Smit VT, Nout RA. Substantial lymph-vascular space invasion (LVSI) is a significant risk factor for recurrence in endometrial cancer--A pooled analysis of PORTEC 1 and 2 trials. Eur J Cancer. 2015 Sep;51(13):1742-50. doi: 10.1016/j.ejca.2015.05.015. Epub 2015 Jun 3.
Reference Type
BACKGROUND
Lee CM, Szabo A, Shrieve DC, Macdonald OK, Gaffney DK. Frequency and effect of adjuvant radiation therapy among women with stage I endometrial adenocarcinoma. JAMA. 2006 Jan 25;295(4):389-97. doi: 10.1001/jama.295.4.389.
Reference Type
BACKGROUND
Kirchheiner K, Czajka-Pepl A, Ponocny-Seliger E, Scharbert G, Wetzel L, Nout RA, Sturdza A, Dimopoulos JC, Dorr W, Potter R. Posttraumatic stress disorder after high-dose-rate brachytherapy for cervical cancer with 2 fractions in 1 application under spinal/epidural anesthesia: incidence and risk factors. Int J Radiat Oncol Biol Phys. 2014 Jun 1;89(2):260-7. doi: 10.1016/j.ijrobp.2014.02.018. Epub 2014 Apr 7.
Reference Type
BACKGROUND
Aalders J, Abeler V, Kolstad P, Onsrud M. Postoperative external irradiation and prognostic parameters in stage I endometrial carcinoma: clinical and histopathologic study of 540 patients. Obstet Gynecol. 1980 Oct;56(4):419-27.
Reference Type
BACKGROUND
Creutzberg CL, van Putten WL, Koper PC, Lybeert ML, Jobsen JJ, Warlam-Rodenhuis CC, De Winter KA, Lutgens LC, van den Bergh AC, van de Steen-Banasik E, Beerman H, van Lent M. Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial. PORTEC Study Group. Post Operative Radiation Therapy in Endometrial Carcinoma. Lancet. 2000 Apr 22;355(9213):1404-11. doi: 10.1016/s0140-6736(00)02139-5.
Reference Type
BACKGROUND
Keys HM, Roberts JA, Brunetto VL, Zaino RJ, Spirtos NM, Bloss JD, Pearlman A, Maiman MA, Bell JG; Gynecologic Oncology Group. A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2004 Mar;92(3):744-51. doi: 10.1016/j.ygyno.2003.11.048.
Reference Type
BACKGROUND
ASTEC/EN.5 Study Group; Blake P, Swart AM, Orton J, Kitchener H, Whelan T, Lukka H, Eisenhauer E, Bacon M, Tu D, Parmar MK, Amos C, Murray C, Qian W. Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN.5 randomised trials): pooled trial results, systematic review, and meta-analysis. Lancet. 2009 Jan 10;373(9658):137-46. doi: 10.1016/S0140-6736(08)61767-5. Epub 2008 Dec 16.
Reference Type
BACKGROUND
Nout RA, Smit VT, Putter H, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Kroese MC, van Bunningen BN, Ansink AC, van Putten WL, Creutzberg CL; PORTEC Study Group. Vaginal brachytherapy versus pelvic external beam radiotherapy for patients with endometrial cancer of high-intermediate risk (PORTEC-2): an open-label, non-inferiority, randomised trial. Lancet. 2010 Mar 6;375(9717):816-23. doi: 10.1016/S0140-6736(09)62163-2.
Reference Type
BACKGROUND
Nout RA, Putter H, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Stenfert Kroese MC, van Bunningen BN, Smit VT, Nijman HW, van den Tol PP, Creutzberg CL. Quality of life after pelvic radiotherapy or vaginal brachytherapy for endometrial cancer: first results of the randomized PORTEC-2 trial. J Clin Oncol. 2009 Jul 20;27(21):3547-56. doi: 10.1200/JCO.2008.20.2424. Epub 2009 Jun 22.
Reference Type
BACKGROUND
Sorbe B, Straumits A, Karlsson L. Intravaginal high-dose-rate brachytherapy for stage I endometrial cancer: a randomized study of two dose-per-fraction levels. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1385-9. doi: 10.1016/j.ijrobp.2004.12.079.
Reference Type
BACKGROUND
McMeekin DS, The University of Oklahoma OC, OK, United States, Filiaci VL, et al. 1A randomized phase III trial of pelvic radiation therapy (PXRT) versus vaginal cuff brachytherapy followed by paclitaxel/carboplatin chemotherapy (VCB/C) in patients with high risk (HR), early stage endometrial cancer (EC): A Gynecologic Oncology Group trial. Gynecol Oncol. 2014;134: 438.
Reference Type
BACKGROUND
Harkenrider MM, Block AM, Alektiar KM, Gaffney DK, Jones E, Klopp A, Viswanathan AN, Small W Jr. American Brachytherapy Task Group Report: Adjuvant vaginal brachytherapy for early-stage endometrial cancer: A comprehensive review. Brachytherapy. 2017 Jan-Feb;16(1):95-108. doi: 10.1016/j.brachy.2016.04.005. Epub 2016 May 31.
Reference Type
BACKGROUND
Delaney G, Jacob S, Barton M. Estimation of an optimal radiotherapy utilization rate for gynecologic carcinoma: part II--carcinoma of the endometrium. Cancer. 2004 Aug 15;101(4):682-92. doi: 10.1002/cncr.20445.
Reference Type
BACKGROUND
Lee CM, Szabo A, Shrieve DC, Macdonald OK, Tward JD, Skidmore TB, Gaffney DK. Descriptive nomograms of adjuvant radiotherapy use and patterns of care analysis for stage I and II endometrial adenocarcinoma: A surveillance, epidemiology, and end results population study. Cancer. 2007 Nov 1;110(9):2092-100. doi: 10.1002/cncr.22997.
Reference Type
BACKGROUND
Punglia RS, Weeks JC, Neville BA, Earle CC. Effect of distance to radiation treatment facility on use of radiation therapy after mastectomy in elderly women. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):56-63. doi: 10.1016/j.ijrobp.2006.03.059. Epub 2006 Jul 11.
Reference Type
BACKGROUND
Scott NW, Fayers PM, Aaronson NK et al (2008) EORTC QLQ-C30 Reference Values. European Organization for Research and Treatment of Cancer.
Reference Type
BACKGROUND
Cocks K, King MT, Velikova G, Fayers PM, Brown JM. Quality, interpretation and presentation of European Organisation for Research and Treatment of Cancer quality of life questionnaire core 30 data in randomised controlled trials. Eur J Cancer. 2008 Sep;44(13):1793-8. doi: 10.1016/j.ejca.2008.05.008. Epub 2008 Jul 1.
Reference Type
BACKGROUND
Maringwa JT, Quinten C, King M, Ringash J, Osoba D, Coens C, Martinelli F, Vercauteren J, Cleeland CS, Flechtner H, Gotay C, Greimel E, Taphoorn MJ, Reeve BB, Koch JS, Weis J, Smit EF, van Meerbeeck JP, Bottomley A; EORTC PROBE project and the Lung Cancer Group. Minimal important differences for interpreting health-related quality of life scores from the EORTC QLQ-C30 in lung cancer patients participating in randomized controlled trials. Support Care Cancer. 2011 Nov;19(11):1753-60. doi: 10.1007/s00520-010-1016-5. Epub 2010 Oct 1.
Reference Type
BACKGROUND
Zafar SY, Peppercorn JM, Schrag D, Taylor DH, Goetzinger AM, Zhong X, Abernethy AP. The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient's experience. Oncologist. 2013;18(4):381-90. doi: 10.1634/theoncologist.2012-0279. Epub 2013 Feb 26.
Reference Type
BACKGROUND
Neugut AI, Subar M, Wilde ET, Stratton S, Brouse CH, Hillyer GC, Grann VR, Hershman DL. Association between prescription co-payment amount and compliance with adjuvant hormonal therapy in women with early-stage breast cancer. J Clin Oncol. 2011 Jun 20;29(18):2534-42. doi: 10.1200/JCO.2010.33.3179. Epub 2011 May 23.
Reference Type
BACKGROUND
de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.
Reference Type
BACKGROUND
Bouberhan S, Shea M, Kennedy A, Erlinger A, Stack-Dunnbier H, Buss MK, Moss L, Nolan K, Awtrey C, Dalrymple JL, Garrett L, Liu FW, Hacker MR, Esselen KM. Financial toxicity in gynecologic oncology. Gynecol Oncol. 2019 Jul;154(1):8-12. doi: 10.1016/j.ygyno.2019.04.003. Epub 2019 Apr 30.
Reference Type
BACKGROUND
Liang MI, Summerlin SS, Blanchard CT, Boitano TKL, Huh WK, Bhatia S, Pisu M. Measuring Financial Distress and Quality of Life Over Time in Patients With Gynecologic Cancer-Making the Case to Screen Early in the Treatment Course. JCO Oncol Pract. 2021 Oct;17(10):e1576-e1583. doi: 10.1200/OP.20.00907. Epub 2021 Feb 17.
Reference Type
BACKGROUND
Soisson S, Ganz PA, Gaffney D, Rowe K, Snyder J, Wan Y, Deshmukh V, Newman M, Fraser A, Smith K, Herget K, Hanson HA, Wu YP, Stanford J, Al-Sarray A, Werner TL, Setiawan VW, Hashibe M. Long-term Cardiovascular Outcomes Among Endometrial Cancer Survivors in a Large, Population-Based Cohort Study. J Natl Cancer Inst. 2018 Dec 1;110(12):1342-1351. doi: 10.1016/j.ygyno.2017.12.025.
Reference Type
BACKGROUND
Lee E, Zhu J, Velazquez J, Bernardo R, Garcia J, Rovito M, Hines RB. Evaluation of Diet Quality Among American Adult Cancer Survivors: Results From 2005-2016 National Health and Nutrition Examination Survey. J Acad Nutr Diet. 2021 Feb;121(2):217-232. doi: 10.1016/j.jand.2020.08.086. Epub 2020 Nov 3.
Reference Type
BACKGROUND
Smits A, Lopes A, Das N, Bekkers R, Massuger L, Galaal K. The effect of lifestyle interventions on the quality of life of gynaecological cancer survivors: A systematic review and meta-analysis. Gynecol Oncol. 2015 Dec;139(3):546-52. doi: 10.1016/j.ygyno.2015.10.002. Epub 2015 Oct 9.
Reference Type
BACKGROUND
Friedenreich CM, Cook LS, Wang Q, Kokts-Porietis RL, McNeil J, Ryder-Burbidge C, Courneya KS. Prospective Cohort Study of Pre- and Postdiagnosis Physical Activity and Endometrial Cancer Survival. J Clin Oncol. 2020 Dec 1;38(34):4107-4117. doi: 10.1200/JCO.20.01336. Epub 2020 Oct 7.
Reference Type
BACKGROUND
Kitson S, Ryan N, MacKintosh ML, Edmondson R, Duffy JM, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2018 Feb 1;2(2):CD012513. doi: 10.1002/14651858.CD012513.pub2.
Reference Type
BACKGROUND
Diet History Questionnaire III (DHQ III) | EGRP/DCCPS/NCI/NIH. Accessed October 29, 2022. https://epi.grants.cancer.gov/dhq3/
Reference Type
BACKGROUND
Krebs-Smith SM, Pannucci TE, Subar AF, Kirkpatrick SI, Lerman JL, Tooze JA, Wilson MM, Reedy J. Update of the Healthy Eating Index: HEI-2015. J Acad Nutr Diet. 2018 Sep;118(9):1591-1602. doi: 10.1016/j.jand.2018.05.021.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2018-00011
Identifier Type: REGISTRY
Identifier Source: secondary_id
HCI103841
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Advanced Endometrial Cancer
NCT00002493
COMPLETED
PHASE3
Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer
NCT04683653
RECRUITING
PHASE1/PHASE2
Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer
NCT00942357
UNKNOWN
PHASE3
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
NCT00005830
COMPLETED
PHASE1
Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
NCT00006011
COMPLETED
PHASE3
Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation
NCT04030000
WITHDRAWN
PHASE1/PHASE2
Intensity-Modulated Radiation Therapy, Cisplatin, and Bevacizumab Followed by Carboplatin and Paclitaxel in Treating Patients Who Have Undergone Surgery for Endometrial Cancer
NCT01005329
COMPLETED
PHASE2
A Phase II Evaluation of Docetaxel and Carboplatin Followed by Tumor Volume Directed Pelvic Irradiation
NCT00285415
TERMINATED
PHASE2
A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care
NCT04834544
RECRUITING
PHASE2
Paclitaxel and Intraperitoneal Carboplatin Followed by Radiation Therapy in Treating Patients With Stage IIIC-IV Uterine Cancer
NCT02112552
TERMINATED
PHASE2
Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers
NCT03345784
TERMINATED
PHASE1
Brachytherapy With Durvalumab or Tremelimumab for the Treatment of Patients With Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies
NCT04395079
ACTIVE_NOT_RECRUITING
PHASE2
A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer
NCT05691010
RECRUITING
EARLY_PHASE1
Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
NCT03914612
ACTIVE_NOT_RECRUITING
PHASE3
A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer
NCT01918124
COMPLETED
PHASE2
Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)
NCT04634877
ACTIVE_NOT_RECRUITING
PHASE3
Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
NCT00066456
COMPLETED
PHASE1
BEZ235 Trial in Patients With Advanced Endometrial Carcinoma
NCT01290406
WITHDRAWN
PHASE2
Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Primary Ovarian or Uterine Cancer
NCT03325634
COMPLETED
PHASE1
A Study of Radiation Therapy and Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma
NCT00231868
COMPLETED
PHASE2
Trial of Cisplatin Plus Radiation Followed by Carbo and Taxol Vs. Sandwich Therapy of Carbo and Taxol Followed Radiation Then Further Carbo and Taxol
NCT02501954
COMPLETED
PHASE3
Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women
NCT06904365
RECRUITING
Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer
NCT00492778
UNKNOWN
PHASE2
Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer
NCT00006027
COMPLETED
PHASE3
Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer
NCT01041027
TERMINATED
PHASE2