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

NCT06102252 — Not applicable, Completed, 60 participants, Sohag University

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RegistryNCT06102252
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment60 (Actual)
SponsorSohag University (Other)
ConditionsEndometrial Carcinoma
InterventionsPaclitaxel/epirubcin/carboplatin, Paclitaxel/carboplatin (Drug)
Datesstart 2024-08-15, primary completion 2025-11-01, completion 2025-12-01, first posted 2023-10-26, last updated 2026-05-22
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Endometrial Carcinoma All trials of Paclitaxel/epirubcin/carboplatin All trials of Paclitaxel/carboplatin

-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

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+Arms and interventions

ArmTypeInterventionsDescription
group AActive comparatorDrug: Paclitaxel/epirubcin/carboplatinwill 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 BActive comparatorDrug: 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
group CActive comparatorDrug: 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
  • Paclitaxel/epirubcin/carboplatin (Drug): adjuvant treatment in endometrial carcinoma
  • Paclitaxel/carboplatin (Drug): Dose dense paclitaxel/carboplatin

+Outcome measures

Primary outcomes

  • Completion rate of chemotherapy [6 months]: 6 cycles

+Eligibility

Sex: Female, ages: 20 Years to 70 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Sohag university HospitalSohagEgypt

+Publications

  • 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
  • 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
  • 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
  • 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