Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions
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
1 other identifier
interventional
624
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2022
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2022
CompletedFirst Posted
Study publicly available on registry
September 1, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
November 23, 2022
August 1, 2022
4 years
August 30, 2022
November 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Failure free survival(FFS)
3-year,5-year
Overall survical(OS)
3-year,5-year
Cumulative vaginal recurrence
3-year,5-year
Cumulative pelvic recurrence
3-year,5-year
Distance metastasis(DM)
3-year,5-year
- +4 more secondary outcomes
Study Arms (2)
Molecular classification based treatment
EXPERIMENTALEstablishment 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.
Conventional risk stratification based treatment
ACTIVE COMPARATORAdjuvant 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)
Interventions
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.
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
No radiotherapy is administrated, but active follow-up and quality of life questionnaires is needed after surgery.
Intravenous concurrent or sequential adjuvant chemotherapy consists of carboplatin/paclitaxel, cisplatin/doxorubicin or cisplatin/doxorubicin/paclitaxel, etc.
Eligibility Criteria
You may qualify if:
- 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:
- Stage IA G1-2 with massive LVSI+ or age ≥ 60 years
- Stage IA G3, regardless of LVSI status
- Stage IB G1-3, regardless of LVSI status
- Stage II, regardless of tumor grade and LVSI status
- Patients can understand the study protocol and voluntarily participate in the study, and give written informed consent before treatment.
You may not qualify if:
- Not FIGO stage I-II.
- Residual tumor or positive margin.
- Mixed carcinoma, sarcoma or carcinosarcoma
- Previous history of malignant tumor
- Previous history of pelvic radiotherapy
- The interval between surgery and radiotherapy is more than 12 weeks.
- With serious medical complications, such as heart disease, lung disease and other diseases that cannot tolerate the whole course of radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking Union Medical College Hospitallead
- The First Affiliated Hospital of Air Force Medicial Universitycollaborator
- The Second Affiliated Hospital of Dalian Medical Universitycollaborator
- Second Hospital of Jilin Universitycollaborator
- First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
- The Affiliated Hospital of Inner Mongolia Medical Universitycollaborator
- Third Affiliated Hospital of Xinjiang Medical Universitycollaborator
- Peking University First Hospitalcollaborator
- 940 Hospital of the People's Liberation Army Joint Logistic Support Forcecollaborator
- Xiangya Hospital of Central South Universitycollaborator
- Cancer Institute and Hospital, Chinese Academy of Medical Sciencescollaborator
Related Publications (1)
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.
PMID: 34779587BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2022
First Posted
September 1, 2022
Study Start
December 1, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
November 23, 2022
Record last verified: 2022-08