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| Name | Class |
|---|---|
| The First Affiliated Hospital of Air Force Medicial University | OTHER |
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
| Second Hospital of Jilin University | OTHER |
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The purpose of this study is to compare the efficacy and toxicity of early stage endometrial cancer based on molecular classification and conventional risk stratification adjuvant therapy decision-making, and to provide high-quality evidence-based medical evidence for individualized adjuvant therapy selection under the guidance of fine stratification system of endometrial cancer.
This is an investigator-initiated prospective, national multicentre, phase III, randomised, open, non-inferiority clinical study. The study hypothesis is that adjuvant radiotherapy decision for early-stage endometrial cancer which is based on molecular classification can achieve de-escalation of adjuvant treatment without reducing local tumour control and survival, thereby potentially further reducing radiotherapy-related toxicity and improving quality of life, compared to using conventional risk stratification. The primary endpoint of this study is the 3-year local recurrence rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Molecular classification based treatment | Experimental | Establishment of molecular-clinicopathological classification to make adjuvant treatment decisions: observation for favourable group; vaginal brachytherapy(VBT) for intermediate group; external beam radiotherapy(EBRT) for unfavourable group. Molecular-clinicopathological classification strategy：Favourable group：POLE-mutated. CTNNB1(wide-type)with IA (G1-3) or IB(G1-2)and LVSI(lymph-vascular space invasion) focal/-. Intermediate group：MMRD and LVSI focal/-. CTNNB1(wide-type) and IB(G3) or II with LVSI focal/-. CTNNB1-mutated and IA(G1-3) or IB (G1-2) with LVSI focal/-. Unfavourable group: TP53 mutation. CTNNB1-mutated and IB (G3) or II. Substantial LVSI. |
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| Conventional risk stratification based treatment | Active Comparator | Adjuvant vaginal brachytherapy alone for intermediate risk patients (IA G1-2 with LVSI present or age>60, IA G3 or IB G1-2 regardless of LVSI status). EBRT for high-intermediate risk (stage I B with G3, or stage II) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal brachytherapy | Radiation | High-dose rate vaginal brachytherapy (VBT) was delivered with a vaginal cylinder.For VBT administered alone, the dose is recommended: 3 fractions of 7 Gy or 5 fractions of 6 Gy or 6 fractions of 5 Gy. For VBT administered after completion of EBRT: 2-3 fractions of 4-6 Gy. |
| Measure | Description | Time Frame |
|---|---|---|
| Loco-regional recurrence (LRR) | Loco-regional recurrence (LRR) is defined as the first recurrence in the vagina or pelvic cavity during follow-up, which was confirmed by imaging examination or biopsy pathology. | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| Failure free survival(FFS) | FFS is defined as the time from randomization to recurrence,distant metastasis or death from any cause,whichever is first. | 3-year,5-year |
| Overall survical(OS) | Overall survival is calculated from randomization to death from any cause. |
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Inclusion Criteria:
Women aged 18-75.
Patients with newly histologically confirmed Endometrioid adenocarcinoma.
ECOG score 0-2
Surgery consisting of a total hysterectomy and bilateral salpingo-oophorectomy, pelvic lymphadenectomy or sentinel lymph node biopsy, with or without para-aortic lymphadenectomy, oophorectomy
Patients with FIGO staging(2009 edition) I or II and meet one of the following conditions:
Patients can understand the study protocol and voluntarily participate in the study, and give written informed consent before treatment.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaorong Hou, PhD | Contact | +86-13811963013 | hxr_pumch@163.com | |
| Xiaorong Hou, PhD | Contact | +86-01069155487 | hxr_pumch@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34779587 | Background | Ren K, Wang W, Sun S, Hou X, Hu K, Zhang F. Recurrent patterns after postoperative radiotherapy for early stage endometrial cancer: A competing risk analysis model. Cancer Med. 2022 Jan;11(1):257-267. doi: 10.1002/cam4.4423. Epub 2021 Nov 15. |
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| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| The Affiliated Hospital of Inner Mongolia Medical University | OTHER |
| Third Affiliated Hospital of Xinjiang Medical University | OTHER |
| Peking University First Hospital | OTHER |
| 940 Hospital of the People's Liberation Army Joint Logistic Support Force | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
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| Pelvic external beam radiotherapy | Radiation | EBRT was delivered to the pelvic area using a total dose of 45-50.4Gy in 25-28 fractions over 5-6 weeks with the intensity-modulated radiotherapy (IMRT) technique, three-dimensional conformal radiotherapy (3D-CRT) modality |
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| Observation | Other | No radiotherapy is administrated, but active follow-up and quality of life questionnaires is needed after surgery. |
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| Chemotherapy | Drug | Intravenous concurrent or sequential adjuvant chemotherapy consists of carboplatin/paclitaxel, cisplatin/doxorubicin or cisplatin/doxorubicin/paclitaxel, etc. |
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| 3-year,5-year |
| Cumulative vaginal recurrence | Recurrence in the vaginal area during follow-up | 3-year,5-year |
| Cumulative pelvic recurrence | Recurrence in the pelvic area, including the vagina, during follow-up | 3-year,5-year |
| Distance metastasis(DM) | Distant metastasis (such as bone, lung, liver, brain, non-pelvic regional lymph node metastasis). | 3-year,5-year |
| De-escalation rate of treatment | Comparison of the proportion of patients in two groups with the same clinicopathologic factors (FIGO, G, LVSI, age) downgraded from EBRT to VBT or from adjuvant radiotherapy (EBRT or VBT) to observation. | 3-year |
| Health-related cancer-specific quality of life | General quality of life and general cancer related symptoms is accessed by Quality of Life Core Questionnaire (QLQC-30), ,scored as quite a bit/very much vs no or mild symptoms | 3-year,5-year |
| Incidence of Acute and lateToxicities | Acute radiation enteritis, radiation cystitis, radiation lymphopenia, late radiation enteritis, radiation cystitis, vaginal stenosis or shortening, lymphedema, bone marrow suppression according to CTCAE v 5.0. | 3-year,5-year |
| Endometrial cancer related health care costs | All hospital based health care costs used with primary treatment or during follow-up for treatment of adverse events and/or treatment for relapse. | 3 years, 5 years |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
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| ID | Term |
|---|---|
| D019370 | Observation |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
| D013812 | Therapeutics |
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