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NCT05524389Not yet recruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 23 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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 (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
624 (estimated)
First submitted
30 Aug 2022
Start date
1 Dec 2022
Primary completion date
1 Dec 2026
Lead sponsor
Peking Union Medical College Hospital
NCT number
NCT05524389

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 624
  • From 1 Dec 2022 to the primary completion date, 1 Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous history of pelvic radiotherapy
  • The interval between surgery and radiotherapy is more than 12 weeks.

Other illness

  • Previous history of malignant tumor
  • With serious medical complications, such as heart disease, lung disease and other diseases that cannot tolerate the whole course of radiotherapy

Other

  • Not FIGO stage I-II.
  • Residual tumor or positive margin.
  • Mixed carcinoma, sarcoma or carcinosarcoma

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.