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Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions

NCT05524389NOT_YET_RECRUITINGPHASE3INTERVENTIONAL

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.

Key Facts

Lead Sponsor

Peking Union Medical College Hospital

Enrollment

624

Start Date

2022-12-01

Completion Date

2026-12-01

Study Type

INTERVENTIONAL

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

Interventions

Vaginal brachytherapyPelvic external beam radiotherapyObservationChemotherapy

Conditions

Endometrial CancerAdjuvant RadiotherapyMolecular Classification

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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.

Time frame: 3-year

Secondary Outcomes

Failure free survival(FFS)

FFS is defined as the time from randomization to recurrence,distant metastasis or death from any cause,whichever is first.

Time frame: 3-year,5-year

Overall survical(OS)

Overall survival is calculated from randomization to death from any cause.

Time frame: 3-year,5-year

Cumulative vaginal recurrence

Recurrence in the vaginal area during follow-up

Time frame: 3-year,5-year

Cumulative pelvic recurrence

Recurrence in the pelvic area, including the vagina, during follow-up

Time frame: 3-year,5-year

Distance metastasis(DM)

Distant metastasis (such as bone, lung, liver, brain, non-pelvic regional lymph node metastasis).

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 3 years, 5 years

Linked Papers

2021-11-15

Recurrent patterns after postoperative radiotherapy for early stage endometrial cancer: A competing risk analysis model

AbstractObjectiveThe study aimed to evaluate site‐specific recurrent patterns via competing risks analysis and hazard function to provide evidence for adjuvant treatment and follow‐up for early staged endometrial cancer (EC).MethodsA total of 858 patients with International Federation of Gynecology and Obstetrics stage I–II EC who received adjuvant radiotherapy at our institution (2000–2017) were included. The radiotherapy modality comprised external beam radiotherapy (EBRT) with or without vaginal brachytherapy (VBT) or VBT alone. Competing risks analysis and hazard rate function were employed to evaluate the recurrence rate according to the ESMO–ESGO–ESTRO risk classification.ResultsThe 5‐year overall survival rates of the low‐risk (LR), intermediate‐risk (IR), high–intermediate risk (HIR), and high‐risk (HR) groups were 96.1%, 95%, 93%, and 89.7%, respectively (p = 0.018). Sixty‐eight patients developed recurrence. The 5‐year incidence of distant recurrence was the highest in the HR group (14.87%), followed by the HIR (7.71%), IR (5.27%), and LR (1.26%) groups (Gray's test, p < 0.001). The LR and IR groups showed late metastasis behaviors for distant metastasis. The HR group presented a large magnitude of distant metastasis with an early peak that increased beyond 3 years. Subgroup analysis revealed that EBRT±VBT tended to reduce the locoregional relapse rate compared with VBT in the HIR–HR group (2.36% vs. 7.73%, Gray's test, p = 0.08).ConclusionThe established competing risk modeling demonstrated different recurrence patterns across the risk groups and radiotherapy modes. A better understanding of the change in site‐specific recurrence behavior allows more targeted adjuvant treatment and surveillance regimens.

Linked Investigators

Kang Ren

Wenhui Wang