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NCT Number: NCT05524389

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.

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Key information

Conditions

Endometrial Cancer Adjuvant Radiotherapy Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Molecular Classification Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Vaginal brachytherapy

Radiation

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.

Other names: VBT

Pelvic external beam radiotherapy

Radiation

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

Other names: Pelvic EBRT

observation

Other

No radiotherapy is administrated, but active follow-up and quality of life questionnaires is needed after surgery.

Chemotherapy

Drug

Intravenous concurrent or sequential adjuvant chemotherapy consists of carboplatin/paclitaxel, cisplatin/doxorubicin or cisplatin/doxorubicin/paclitaxel, etc.

Primary outcomes

  1. Loco-regional recurrence (LRR)

    Time frame: 3-year

    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.

Secondary outcomes

  1. Failure free survival(FFS)

    Time frame: 3-year,5-year

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

  2. Overall survical(OS)

    Time frame: 3-year,5-year

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

  3. Cumulative vaginal recurrence

    Time frame: 3-year,5-year

    Recurrence in the vaginal area during follow-up

  4. Cumulative pelvic recurrence

    Time frame: 3-year,5-year

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

  5. Distance metastasis(DM)

    Time frame: 3-year,5-year

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

  6. De-escalation rate of treatment

    Time frame: 3-year

    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.

  7. Health-related cancer-specific quality of life

    Time frame: 3-year,5-year

    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

  8. Incidence of Acute and lateToxicities

    Time frame: 3-year,5-year

    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.

  9. Endometrial cancer related health care costs

    Time frame: 3 years, 5 years

    All hospital based health care costs used with primary treatment or during follow-up for treatment of adverse events and/or treatment for relapse.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaorong Hou, PhD

CONTACT

[email protected]

+86-13811963013

Xiaorong Hou, PhD

CONTACT

[email protected]

+86-01069155487

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • 940 Hospital of the People's Liberation Army Joint Logistic Support Force
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • First Affiliated Hospital Xi'an Jiaotong University
  • Peking University First Hospital
  • Second Hospital of Jilin University
  • The Affiliated Hospital of Inner Mongolia Medical University
  • The First Affiliated Hospital of Air Force Medicial University
  • The Second Affiliated Hospital of Dalian Medical University
  • Third Affiliated Hospital of Xinjiang Medical University
  • Xiangya Hospital of Central South University

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 1, 2022
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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