A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
Overview
- Phase
- Phase 3
- Intervention
- Paclitaxel
- Conditions
- Endometrial Neoplasms
- Sponsor
- Ding Ma
- Enrollment
- 300
- Locations
- 3
- Primary Endpoint
- Disease-free survival (DFS)
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma.
Investigators
Ding Ma
Director of the department of Obstetrics and Gynecology, Tongji Hospital
Huazhong University of Science and Technology
Eligibility Criteria
Inclusion Criteria
- •FIGO stage: Ⅰ, endometrial carcinoma;
- •Female, Chinese women;
- •Initial treatment is staging surgery;
- •Pathological diagnosis: Endometrial adenocarcinoma;
- •Pathologic examination and meet the following one of the indications of adjuvant therapy: ① histopathological grading in poorly differentiated: G3; ② ≥50% myometrial invasion; ③ vascular space involvement;
- •No prior treatment;
- •Provide written informed consent.
Exclusion Criteria
- •Unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;
- •Family history of ovarian cancer;
- •Suffering from other malignancies;
- •Concurrently participating in other clinical trials;
- •Unable or unwilling to sign informed consents;
- •Unable or unwilling to abide by protocol.
Arms & Interventions
Adjuvant Chemotherapy
Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary.
Intervention: Paclitaxel
Adjuvant Chemotherapy
Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary.
Intervention: Paraplatin (Carboplatin Injection)
Adjuvant Radiotherapy
1. Histopathological grade G3 and \<50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times; 2. Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy; 3. ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times.
Intervention: Pelvic Radiation
Adjuvant Radiotherapy
1. Histopathological grade G3 and \<50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times; 2. Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy; 3. ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times.
Intervention: Vaginal Brachytherapy 1
Adjuvant Radiotherapy
1. Histopathological grade G3 and \<50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times; 2. Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy; 3. ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times.
Intervention: Vaginal brachytherapy 2
Outcomes
Primary Outcomes
Disease-free survival (DFS)
Time Frame: 3-year DFS
Secondary Outcomes
- Side effect of adjuvant chemotherapy(3-month，6-month，1-year and 3-year)
- Complications of radiotherapy(3-month，6-month，1-year and 3-year)
- Quality of Life(3-month，6-month，1-year and 3-year)
- Overall survival (OS)(3-year OS)