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| Name | Class |
|---|---|
| Tongji Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Obstetrics & Gynecology Hospital of Fudan University | OTHER |
| Sun Yat-sen University |
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This is a prospective, multicenter, randomized phase III trial among women with endometrioid adenocarcinoma with high-intermediate and intermediate risk features to investigate the role of integrated genomic-pathologic classification to determine if participants should receive no adjuvant therapy, vaginal brachytherapy, external beam radiotherapy or chemo-radiation therapy based on molecular features as compared to standard radiation therapy.
Adjuvant therapy for women with endometrial cancer has increasingly been tailored to prognostic factors to prevent overtreatment and select those women for adjuvant treatment who will have a clinically relevant reduction of the risk of relapse by the adjuvant treatment. Risk profiles have traditionally been based on clinicopathological factors such as age, stage, grade, Lymph-Vascular Space Invasion (LVSI) and depth of invasion. Newer, both molecular-genetic (the cancer genome atlas subgroups) have become available which are strongly related to outcomes and risk of cancer spread. Based on 2022 National Comprehensive Cancer Network (NCCN) guideline and the ongoing "Portec-4a" trial, this randomized trial using integrated genomic-pathologic classification to assign adjuvant treatment for women with stage I-II high-intermediate and intermediate risk endometrioid adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Molecular profile based treatment | Experimental | 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. |
|
| Radiotherapy | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal brachytherapy | Radiation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total recurrence | Vaginal, pelvic or distant recurrence as first failure | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival | Relapse-free survival (survival without relapse) | 3 years, 5 years |
| Survival | Overall survival (all-cause death) |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence (vaginal and total) per risk profile | Vaginal, pelvic and distant relapse split by risk profile and compared between the 2 arms | 3 years, 5 years |
Inclusion Criteria:
Surgery consisting of a total abdominal or laparoscopic hysterectomy, bilateral salpingectomy, pelvic lymphadenectomy or sentinel lymph node mapping and dissection, with or without para-aortic lymphadenectomy, oophorectomy
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
World Health Organization (WHO)-performance status 0-2
Written informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinyu Wang, MD | Contact | +86-571-87061501 | wangxinyu@zju.edu.cn | |
| Yang Li, PhD | Contact | +86-571-87061501 | li_yang@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xinyu Wang, MD | Women's Hospital School Of Medicine Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33397713 | Background | 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. | |
| 32749941 |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D019370 | Observation |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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| 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 |
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|
| External beam radiotherapy | Radiation | External beam pelvic radiotherapy on a linear accelerator, 45-50 Gy in 25-28 out-patients sessions |
|
| Observation | Other | No adjuvant therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment |
|
| Chemoradiation therapy | Combination Product | 4 adjuvant cycles carboplatin and paclitaxel followed by External beam pelvic radiotherapy (45-50 Gy ) |
|
| 3 years, 5 years |
| Adverse events | Treatment-related symptoms according to CTCAE v 5.0 | 3 years, 5 years |
| Health-related cancer-specific quality of life | Quality of Life Core Questionnaire (QLQC-30) - clinically relevant changes on Quality of Life Core Questionnaire-30 functioning scales, general quality of life and general cancer symptoms, quite a bit/very much vs no or mild symptoms | 3 years, 5 years |
| Endometrial cancer related health care costs | All hospital based health care costs used with primary treatment or during followup for treatment of adverse events and/or treatment for relapse | 3 years, 5 years |
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | China |
|
| Women's Hospital School of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| Peking University Peoples Hospital | Not yet recruiting | Beijing | China |
|
| Xiangya Hospital of Central South University | Recruiting | Changsha | China |
|
| Sun Yat-Sen University Cancer Hospital | Not yet recruiting | Guangzhou | China |
|
| Ningbo First Hospital | Recruiting | Ningbo | China |
|
| Ningbo Women and Children's Hospital | Recruiting | Ningbo | China |
|
| Obstetrics & Gynecology Hospital of Fudan University | Not yet recruiting | Shanghai | China |
|
| Shanghai First Maternity and Infant Hospital | Not yet recruiting | Shanghai | China |
|
| Background |
| 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. |
| 30078506 | Background | 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. |
| 29449189 | Background | 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. |
| 31829442 | Background | 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. |
| 36659832 | Derived | 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. |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |