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

Last updated: November 20, 2022
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Not Recruiting

Phase

3

Condition

Vaginal Cancer

Pelvic Cancer

Endometriosis

Treatment

N/A

Clinical Study ID

NCT05524389
ECMC-GART
  • Ages 18-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

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, pelviclymphadenectomy or sentinel lymph node biopsy, with or without para-aorticlymphadenectomy, oophorectomy
  5. Patients with FIGO staging(2009 edition) I or II and meet one of the followingconditions:
  6. Stage IA G1-2 with massive LVSI+ or age ≥ 60 years
  7. Stage IA G3, regardless of LVSI status
  8. Stage IB G1-3, regardless of LVSI status
  9. Stage II, regardless of tumor grade and LVSI status
  10. Patients can understand the study protocol and voluntarily participate in the study,and give written informed consent before treatment.

Exclusion

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 otherdiseases that cannot tolerate the whole course of radiotherapy

Study Design

Total Participants: 624
Study Start date:
December 01, 2022
Estimated Completion Date:
June 30, 2027

Study Description

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.