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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

624 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2027-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Endometrial Cancer Adjuvant Radiotherapy Molecular Classification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Molecular classification based treatment

Establishment 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.

Group Type EXPERIMENTAL

Vaginal brachytherapy

Intervention Type 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.

Pelvic external beam radiotherapy

Intervention Type 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

Observation

Intervention Type OTHER

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

Chemotherapy

Intervention Type DRUG

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

Conventional risk stratification based treatment

Adjuvant 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)

Group Type ACTIVE_COMPARATOR

Vaginal brachytherapy

Intervention Type 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.

Pelvic external beam radiotherapy

Intervention Type 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

Chemotherapy

Intervention Type DRUG

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

Interventions

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Vaginal brachytherapy

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.

Intervention Type RADIATION

Pelvic external beam radiotherapy

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

Intervention Type RADIATION

Observation

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

Intervention Type OTHER

Chemotherapy

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

Intervention Type DRUG

Other Intervention Names

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VBT Pelvic EBRT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No