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

• Sponsor: Sohag University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06102252
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Endometrial Carcinoma	Drug: Paclitaxel/epirubcin/carboplatin; Drug: Paclitaxel/carboplatin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Combination Chemotherapy of Paclitaxel and Carboplatin With or Without Anthracycline as an Adjuvant Treatment in Endometrial Carcinoma
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Nov 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Completion rate of chemotherapy [6 months]

   6 cycles

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag university Hospital	Sohag		Egypt	Sohag

Sponsors and Collaborators

• Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Asmaa Gamal Mahmoud, assistant lecteurer oncology department sohag univerisity hospital, Sohag University
• ClinicalTrials.gov Identifier: NCT06102252
• Other Study ID Numbers: soh-Med-23-10-8MS
• First Posted: Oct 26, 2023
• Last Update Posted: Oct 26, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Endometrial Neoplasms; Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin

Study Results

No Results Posted as of Oct 26, 2023