Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)
Overview
- Phase
- Phase 2
- Intervention
- Paclitaxel
- Conditions
- Esophagus Cancer
- Sponsor
- Fudan University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Local control rate
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.
Investigators
Kuai Le Zhao, MD
Prof
Fudan University
Eligibility Criteria
Inclusion Criteria
- •Joined the study voluntarily and signed informed consent form;
- •Age 18-75;
- •ECOG 0-2;
- •Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
- •The operative incision healed well;
- •T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);
- •No radiotherapy, chemotherapy or other treatments pre (post) surgery;
- •PS ECOG 0-2;
- •Life expectancy of more than 3 months;
- •Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 109/L;
Exclusion Criteria
- •Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
- •Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
- •Participation in other interventional clinical trials within 30 days;
- •Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
- •Drug addiction, Alcoholism or AIDS;
- •Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
- •Unsuitable to be enrolled in the trial in the opinion of the investigators.
Arms & Interventions
Concurrent chemoradiotherapy group
Interventions: * Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw\*5 * Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions.
Intervention: Paclitaxel
Concurrent chemoradiotherapy group
Interventions: * Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw\*5 * Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions.
Intervention: Carboplatin
Concurrent chemoradiotherapy group
Interventions: * Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw\*5 * Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions.
Intervention: Radiotherapy
Outcomes
Primary Outcomes
Local control rate
Time Frame: 2 years
Secondary Outcomes
- Overall survival(5 years)