AzTrials
AzTrials

Endometrial CancerPhase 3NCT05524389

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

A Phase 3 study testing Vaginal brachytherapy, Pelvic external beam radiotherapy and Observation in people with Endometrial Cancer and Adjuvant Radiotherapy, run by Peking Union Medical College Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Vaginal brachytherapy, Pelvic external beam radiotherapy and Observation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
624 participants
Where
No sites listed yet
Study dates
1 Dec 2022to 30 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xiaorong Hou, PhD contact

+86-13811963013

hxr_pumch@163.com

Xiaorong Hou, PhD contact

+86-01069155487

hxr_pumch@163.com

About this study

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

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.

Read the detailed 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.

Being tested
Vaginal brachytherapy, Pelvic external beam radiotherapy, Observation, Chemotherapy
Keywords
Endometrial Cancer
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vaginal brachytherapyRadiation

    Also called VBT

    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.

  • Pelvic external beam radiotherapyRadiation

    Also called Pelvic EBRT

    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

  • ObservationOther

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

  • ChemotherapyDrug

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

Study groups in NCT05524389
Study groupRoleWhat they receive
Molecular classification based treatmentExperimentalEstablishment 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.
Receives: Radiation: Vaginal brachytherapy; Radiation: Pelvic external beam radiotherapy; Other: Observation; Drug: Chemotherapy
Conventional risk stratification based treatmentActive 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)
Receives: Radiation: Vaginal brachytherapy; Radiation: Pelvic external beam radiotherapy; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3-year

Secondary outcomes (9)

  1. Failure free survival(FFS)

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

    Measured: 3-year,5-year

  2. Overall survical(OS)

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

    Measured: 3-year,5-year

  3. Cumulative vaginal recurrence

    Recurrence in the vaginal area during follow-up

    Measured: 3-year,5-year

  4. Cumulative pelvic recurrence

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

    Measured: 3-year,5-year

  5. Distance metastasis(DM)

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

    Measured: 3-year,5-year

  6. 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.

    Measured: 3-year

  7. 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

    Measured: 3-year,5-year

  8. 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.

    Measured: 3-year,5-year

  9. 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.

    Measured: 3 years, 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2022
  2. Study start1 Dec 2022 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
624 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05524389
Sponsor's protocol ID
ECMC-GART
Status last verified
Aug 2022
First submitted
30 Aug 2022
Last updated
23 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34779587

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vaginal brachytherapy, Pelvic external beam radiotherapy and Observation in people with Endometrial Cancer and Adjuvant Radiotherapy, run by Peking Union Medical College Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaorong Hou, PhD (+86-13811963013, hxr_pumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loco-regional recurrence (LRR) (time frame: 3-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05524389, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.

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