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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06102252
Other study ID # soh-Med-23-10-8MS
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2023
Est. completion date November 2025

Study information

Verified date October 2023
Source Sohag University
Contact ASMAA G GAMAL, assistant lecutrer
Phone 01003773633
Email asmaa.gamal@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date November 2025
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Paclitaxel/epirubcin/carboplatin
adjuvant treatment in endometrial carcinoma
Paclitaxel/carboplatin
Dose dense paclitaxel/carboplatin

Locations

Country Name City State
Egypt Sohag university Hospital Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Completion rate of chemotherapy 6 cycles 6 months
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