Endometrial Cancer Clinical Trial
Official title:
A Prospective Multicentre Phase III Randomised Open Clinical Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions
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.
Status | Not yet recruiting |
Enrollment | 624 |
Est. completion date | June 30, 2027 |
Est. primary completion date | December 1, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Women aged 18-75. 2. Patients with newly histologically confirmed Endometrioid adenocarcinoma. 3. ECOG score 0-2 4. Surgery consisting of a total hysterectomy and bilateral salpingo-oophorectomy, pelvic lymphadenectomy or sentinel lymph node biopsy, with or without para-aortic lymphadenectomy, oophorectomy 5. Patients with FIGO staging(2009 edition) I or II and meet one of the following conditions: 1. Stage IA G1-2 with massive LVSI+ or age = 60 years 2. Stage IA G3, regardless of LVSI status 3. Stage IB G1-3, regardless of LVSI status 4. Stage II, regardless of tumor grade and LVSI status 6. Patients can understand the study protocol and voluntarily participate in the study, and give written informed consent before treatment. Exclusion Criteria: 1. Not FIGO stage I-II. 2. Residual tumor or positive margin. 3. Mixed carcinoma, sarcoma or carcinosarcoma 4. Previous history of malignant tumor 5. Previous history of pelvic radiotherapy 6. The interval between surgery and radiotherapy is more than 12 weeks. 7. With serious medical complications, such as heart disease, lung disease and other diseases that cannot tolerate the whole course of radiotherapy |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Peking Union Medical College Hospital | Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Affiliated Hospital Xi'an Jiaotong University, Peking University First Hospital, The 940th Hospital of Joint Logistics Support Force,PLA., The Affiliated Hospital of Inner Mongolia Medical University, The Second Affiliated Hospital of Dalian Medical University, The second hospital Affiliated by Jilin University, Third Affiliated Hospital of Xinjiang Medical University, Xiangya Hospital of Central South University, Xijing Hospital, Air Force Medical University of PLA |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Overall survical(OS) | Overall survival is calculated from randomization to death from any cause. | 3-year,5-year | |
Secondary | Cumulative vaginal recurrence | Recurrence in the vaginal area during follow-up | 3-year,5-year | |
Secondary | Cumulative pelvic recurrence | Recurrence in the pelvic area, including the vagina, during follow-up | 3-year,5-year | |
Secondary | Distance metastasis(DM) | Distant metastasis (such as bone, lung, liver, brain, non-pelvic regional lymph node metastasis). | 3-year,5-year | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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