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

Not Applicable

Not yet recruiting

• Conditions: Endometrial Carcinoma
• Interventions: Drug: Paclitaxel/carboplatin; Drug: Paclitaxel/epirubcin/carboplatin

• Registration Number: NCT06102252
• Lead Sponsor: Sohag University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-22
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-04
• Last Update Posted: 2024-08-06
• Study Start: 2024-08-15
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group C	Paclitaxel/carboplatin	: 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 A	Paclitaxel/epirubcin/carboplatin	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 B	Paclitaxel/carboplatin	) 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

Primary Outcome Measures

Name	Time	Method
Completion rate of chemotherapy	6 months	6 cycles

Trial Locations

Locations (1)

Sohag university Hospital; 🇪🇬 Sohag, Egypt