Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
590 participants
INTERVENTIONAL
2022-01-24
2027-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Molecular profile based treatment
Determination of the integrated genomic-pathologic profile to determine adjuvant treatment: observation for POLE-mutated profile; vaginal brachytherapy for intermediate profile; chemo-radiotherapy for p53-abnormal profile.
Vaginal brachytherapy
Internal radiation of the vaginal vault using a vaginal cylinder. For brachytherapy administered alone it is recommended: suggested dose is either 3 fractions of 7 Gy or 5 fractions of 6 Gy.
For brachytherapy administered after completion of External beam radiotherapy (EBRT):
Total dose should aim to be 65 Gy, and suggested dose is 2-3 fractions of 5-6 Gy
Observation
No adjuvant therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment
Chemoradiation therapy
4 adjuvant cycles carboplatin and paclitaxel followed by External beam pelvic radiotherapy (45-50 Gy )
Radiotherapy
Adjuvant vaginal brachytherapy for intermediate risk (stage I A with G3 or stage I B with G1-2) and external beam pelvic radiotherapy for high-intermediate risk (stage I B with G3, or stage II) (standard treatment)
Vaginal brachytherapy
Internal radiation of the vaginal vault using a vaginal cylinder. For brachytherapy administered alone it is recommended: suggested dose is either 3 fractions of 7 Gy or 5 fractions of 6 Gy.
For brachytherapy administered after completion of External beam radiotherapy (EBRT):
Total dose should aim to be 65 Gy, and suggested dose is 2-3 fractions of 5-6 Gy
External beam radiotherapy
External beam pelvic radiotherapy on a linear accelerator, 45-50 Gy in 25-28 out-patients sessions
Interventions
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Vaginal brachytherapy
Internal radiation of the vaginal vault using a vaginal cylinder. For brachytherapy administered alone it is recommended: suggested dose is either 3 fractions of 7 Gy or 5 fractions of 6 Gy.
For brachytherapy administered after completion of External beam radiotherapy (EBRT):
Total dose should aim to be 65 Gy, and suggested dose is 2-3 fractions of 5-6 Gy
External beam radiotherapy
External beam pelvic radiotherapy on a linear accelerator, 45-50 Gy in 25-28 out-patients sessions
Observation
No adjuvant therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment
Chemoradiation therapy
4 adjuvant cycles carboplatin and paclitaxel followed by External beam pelvic radiotherapy (45-50 Gy )
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed endometrioid type endometrial carcinoma, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I, with one of the following combinations of stage and grade:
Stage I A, grade 3 Stage I B, grade 1 or 2 Stage I B, grade 3 Stage II
3. World Health Organization (WHO)-performance status 0-2
4. Written informed consent
Exclusion Criteria
2. Any other stage and type of endometrial carcinoma
3. Histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma
4. Uterine sarcoma (including carcinosarcoma)
5. Previous malignancy (except for non-melanomatous skin cancer)
6. Previous pelvic radiotherapy
7. Expected interval between the operation and start of radiotherapy exceeding 8 weeks
18 Years
75 Years
FEMALE
No
Sponsors
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Tongji Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Obstetrics & Gynecology Hospital of Fudan University
OTHER
Sun Yat-sen University
OTHER
Peking University People's Hospital
OTHER
Shanghai First Maternity and Infant Hospital
OTHER
Xiangya Hospital of Central South University
OTHER
Anhui Provincial Cancer Hospital
OTHER
Ningbo Women & Children's Hospital
OTHER
Ningbo No. 1 Hospital
OTHER
Women's Hospital School Of Medicine Zhejiang University
OTHER
Responsible Party
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Wang Xinyu
Clinical Professor
Principal Investigators
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Xinyu Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Women's Hospital School Of Medicine Zhejiang University
Locations
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Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Peking University Peoples Hospital
Beijing, , China
Xiangya Hospital of Central South University
Changsha, , China
Sun Yat-Sen University Cancer Hospital
Guangzhou, , China
Ningbo First Hospital
Ningbo, , China
Ningbo Women and Children's Hospital
Ningbo, , China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, , China
Shanghai First Maternity and Infant Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Zhiqi Wang
Role: primary
Yu Zhang, MD
Role: primary
Yanling Feng
Role: primary
Yutao Guan
Role: primary
Lingjun Zhao
Role: primary
Xiaoping Wan
Role: primary
References
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Concin N, Matias-Guiu X, Vergote I, Cibula D, Mirza MR, Marnitz S, Ledermann J, Bosse T, Chargari C, Fagotti A, Fotopoulou C, Gonzalez Martin A, Lax S, Lorusso D, Marth C, Morice P, Nout RA, O'Donnell D, Querleu D, Raspollini MR, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Colombo N, Planchamp F, Creutzberg CL. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer. 2021 Jan;31(1):12-39. doi: 10.1136/ijgc-2020-002230. Epub 2020 Dec 18.
Leon-Castillo A, de Boer SM, Powell ME, Mileshkin LR, Mackay HJ, Leary A, Nijman HW, Singh N, Pollock PM, Bessette P, Fyles A, Haie-Meder C, Smit VTHBM, Edmondson RJ, Putter H, Kitchener HC, Crosbie EJ, de Bruyn M, Nout RA, Horeweg N, Creutzberg CL, Bosse T; TransPORTEC consortium. Molecular Classification of the PORTEC-3 Trial for High-Risk Endometrial Cancer: Impact on Prognosis and Benefit From Adjuvant Therapy. J Clin Oncol. 2020 Oct 10;38(29):3388-3397. doi: 10.1200/JCO.20.00549. Epub 2020 Aug 4.
Wortman BG, Bosse T, Nout RA, Lutgens LCHW, van der Steen-Banasik EM, Westerveld H, van den Berg H, Slot A, De Winter KAJ, Verhoeven-Adema KW, Smit VTHBM, Creutzberg CL; PORTEC Study Group. Molecular-integrated risk profile to determine adjuvant radiotherapy in endometrial cancer: Evaluation of the pilot phase of the PORTEC-4a trial. Gynecol Oncol. 2018 Oct;151(1):69-75. doi: 10.1016/j.ygyno.2018.07.020. Epub 2018 Aug 3.
de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, Colombo A, Fyles A, Baron MH, Jurgenliemk-Schulz IM, Kitchener HC, Nijman HW, Wilson G, Brooks S, Carinelli S, Provencher D, Hanzen C, Lutgens LCHW, Smit VTHBM, Singh N, Do V, D'Amico R, Nout RA, Feeney A, Verhoeven-Adema KW, Putter H, Creutzberg CL; PORTEC study group. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Mar;19(3):295-309. doi: 10.1016/S1470-2045(18)30079-2. Epub 2018 Feb 12.
Leon-Castillo A, Britton H, McConechy MK, McAlpine JN, Nout R, Kommoss S, Brucker SY, Carlson JW, Epstein E, Rau TT, Bosse T, Church DN, Gilks CB. Interpretation of somatic POLE mutations in endometrial carcinoma. J Pathol. 2020 Mar;250(3):323-335. doi: 10.1002/path.5372. Epub 2020 Jan 29.
Li Y, Zhu C, Xie H, Chen Y, Lv W, Xie X, Wang X. Molecular profile-based recommendations for postoperative adjuvant therapy in early endometrial cancer with high-intermediate or intermediate risk: a Chinese randomized phase III trial (PROBEAT). J Gynecol Oncol. 2023 Mar;34(2):e37. doi: 10.3802/jgo.2023.34.e37. Epub 2023 Jan 10.
Other Identifiers
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IRB-20210340-R
Identifier Type: -
Identifier Source: org_study_id
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