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

October 25, 2023 updated by: Asmaa Gamal Mahmoud, Sohag University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: ELSAYED M MOSTAFA, professor

Study Locations

  • Egypt
      • Sohag, Egypt, Sohag
        • Sohag university Hospital
        • Contact:
          • Magdy M Amin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:• Age group: Histologically diagnosed with primary endometrial carcinoma

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Paclitaxel/epirubcin/carboplatin
adjuvant treatment in endometrial carcinoma
Active Comparator: 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
Drug: Paclitaxel/carboplatin
Dose dense paclitaxel/carboplatin
Active Comparator: 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
Drug: Paclitaxel/carboplatin
Dose dense paclitaxel/carboplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion rate of chemotherapy
Time Frame: 6 months
6 cycles
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

October 22, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-23-10-8MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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