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

NCT06102252 | Completed

• 1 other identifier: Soh-Med-24-7-01MD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Endometrial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Completion rate of chemotherapy

  6 cycles

  6 months

Study Arms (3)

group A

ACTIVE COMPARATOR

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

group B

ACTIVE COMPARATOR

) 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

group C

ACTIVE COMPARATOR

: 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

Interventions

Paclitaxel/epirubcin/carboplatin DRUG

adjuvant treatment in endometrial carcinoma

group A

Paclitaxel/carboplatin DRUG

Dose dense paclitaxel/carboplatin

group B; group C

Eligibility Criteria

• Age: 20 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pt has received prior radiation or chemotherapy.
• Pt with sarcomatous component
• Metastatic endometrial carcinoma
• Other malignancy
• Unfit patient for chemotherapy

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Sohag, Egypt

Location

Related Publications (4)

• Colombo N, Creutzberg C, Amant F, Bosse T, Gonzalez-Martin A, Ledermann J, Marth C, Nout R, Querleu D, Mirza MR, Sessa C; ESMO-ESGO-ESTRO Endometrial Consensus Conference Working Group. ESMO-ESGO-ESTRO Consensus Conference on Endometrial Cancer: Diagnosis, Treatment and Follow-up. Int J Gynecol Cancer. 2016 Jan;26(1):2-30. doi: 10.1097/IGC.0000000000000609.

  PMID: 26645990 BACKGROUND

• Bestvina CM, Fleming GF. Chemotherapy for Endometrial Cancer in Adjuvant and Advanced Disease Settings. Oncologist. 2016 Oct;21(10):1250-1259. doi: 10.1634/theoncologist.2016-0062. Epub 2016 Jul 13.

  PMID: 27412393 BACKGROUND

• Fujiwara K, Egawa-Takata T, Ueda Y, Kimura T, Yoshino K, Fujita M, Miyatake T, Ohta Y, Kamiura S, Enomoto T, Kimura T. Investigating the relative efficacies of combination chemotherapy of paclitaxel/carboplatin, with or without anthracycline, for endometrial carcinoma. Arch Gynecol Obstet. 2012 May;285(5):1447-53. doi: 10.1007/s00404-011-2154-9. Epub 2011 Nov 30.

  PMID: 22127553 BACKGROUND

• Randall ME, Filiaci VL, Muss H, Spirtos NM, Mannel RS, Fowler J, Thigpen JT, Benda JA; Gynecologic Oncology Group Study. Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2006 Jan 1;24(1):36-44. doi: 10.1200/JCO.2004.00.7617. Epub 2005 Dec 5.

  PMID: 16330675 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Paclitaxel; CP protocol

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecteurer oncology department sohag univerisity hospital

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: August 15, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

EG (1)