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Trial Title:
Combination Chemotherapy of Paclitaxel and Carboplatin With or Without Anthracycline as Aneo Adjuvant Treatment in Advanced Endometrial Carcinoma
NCT ID:
NCT06102252
Condition:
Endometrial Carcinoma
Conditions: Official terms:
Carcinoma
Endometrial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Paclitaxel/epirubcin/carboplatin
Description:
adjuvant treatment in endometrial carcinoma
Arm group label:
group A
Intervention type:
Drug
Intervention name:
Paclitaxel/carboplatin
Description:
Dose dense paclitaxel/carboplatin
Arm group label:
group B
Arm group label:
group C
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
Criteria for 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
Gender:
Female
Gender based:
Yes
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Sohag university Hospital
Address:
City:
Sohag
Zip:
Sohag
Country:
Egypt
Contact:
Last name:
Magdy M Amin
Start date:
August 15, 2024
Completion date:
August 2025
Lead sponsor:
Agency:
Sohag University
Agency class:
Other
Source:
Sohag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06102252
