The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
Phase 3
Active, not recruiting
- Conditions
- Endometrial Neoplasms
- Interventions
- Radiation: Pelvic RadiationRadiation: Vaginal Brachytherapy 1Radiation: Vaginal brachytherapy 2
- Registration Number
- NCT01820858
- Lead Sponsor
- Ding Ma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 300
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adjuvant Chemotherapy Paraplatin (Carboplatin Injection) Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary. Adjuvant Radiotherapy Pelvic Radiation 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. Adjuvant Radiotherapy Vaginal Brachytherapy 1 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. Adjuvant Radiotherapy Vaginal brachytherapy 2 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. Adjuvant Chemotherapy Paclitaxel Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary.
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS) 3-year DFS
- Secondary Outcome Measures
Name Time Method Side effect of adjuvant chemotherapy 3-month，6-month，1-year and 3-year The incidence of infusion reactions (i.e.,skin reactions, cardiovascular reactions, respiratory or throat tightness), and allergic reactions (i.e., life-threatening anaphylaxis)
Complications of radiotherapy 3-month，6-month，1-year and 3-year To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis.
Quality of Life 3-month，6-month，1-year and 3-year Overall survival (OS) 3-year OS
Trial Locations
- Locations (3)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Qilu Hospital，Shandong University
🇨🇳Jinan, Shandong, China
Women's Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China