Clinical trial NCT06102252: Combination Chemotherapy of Paclitaxel and Carboplatin With or Without Anthracycline as Aneo Adjuvant Treatment in Advanced Endometrial Carcinoma
Official title: Combination Chemotherapy of Paclitaxel and Carboplatin With or Without Anthracycline as Aneo Adjuvant Treatment in Advanced Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometrial Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Completion rate of chemotherapy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
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.
citation: 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.
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.
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.