Combination Chemotherapy of Paclitaxel and Carboplatin With or Without Anthracycline as Aneo Adjuvant Treatment in Advanced Endometrial Carcinoma

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

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-08-31

Brief Summary

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Endometrial cancer, the most common gynecologic cancer worldwide, is steadily increasing in developed countries.The early-stage forms of endometrial cancer are usually highly curable by surgical treatment alone, whereas advanced stages require adjuvant interdictions such as radiotherapy and chemotherapy. Platinum and anthracycline drugs have long been used as standard adjuvant chemotherapy drugs for advanced and recurrent endometrial carcinomas. In one study, the standard combination adjuvant treatment with AP was found to be more effective as an adjuvant therapy than whole abdominal irradiation

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Detailed Description

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Conditions

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Endometrial Carcinoma

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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group A

will receive the TEC regimen: paclitaxel 150mg/m2 infused for 3 hours, epirubicin 50mg/m2 infused for 30 minutes, and carboplatin 4mg/ml/min for one hour on day 1 every 3 weeks.

Group Type ACTIVE_COMPARATOR

Paclitaxel/epirubcin/carboplatin

Intervention Type DRUG

adjuvant treatment in endometrial carcinoma

group B

) will receive a ddTC regimen: paclitaxel 80mg/m2 for 3 hours on day 1,8,15. Carboplatin AUC 5 over one hour on day 1 repeated at 3-week intervals

Group Type ACTIVE_COMPARATOR

Paclitaxel/carboplatin

Intervention Type DRUG

Dose dense paclitaxel/carboplatin

group C

: paclitaxel 175 mg/m2 over 3 hours infusion on day 1-carboplatin AUC 5 over 1 hour on day 1 at 3 weeks intervals

Group Type ACTIVE_COMPARATOR

Paclitaxel/carboplatin

Intervention Type DRUG

Dose dense paclitaxel/carboplatin

Interventions

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Paclitaxel/epirubcin/carboplatin

adjuvant treatment in endometrial carcinoma

Intervention Type DRUG

Paclitaxel/carboplatin

Dose dense paclitaxel/carboplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* more than 20 years old.

* Any histological type of endometrial carcinoma
* Stage III, IV
* Stage one I or II with one or more of the following factors:

1. Histologic grade 3 endometroid carcinoma with myometrial invasion still within half of the myometrium
2. histological grade 1,2 endometroid carcinomas with invasion of over half of myometrium
3. cervical stromal invasion
4. vascular invasion; or
5. serous carcinoma, clear cell carcinoma, or undifferentiated carcinoma
* performance status 0-2
* adequate function of all major organs

Exclusion Criteria

* • Pt has received prior radiation or chemotherapy.

* Pt with sarcomatous component
* Metastatic endometrial carcinoma
* Other malignancy
* Unfit patient for chemotherapy

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes