Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma

Phase 2

Completed

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Paclitaxel; Drug: Carboplatin; Radiation: Radiotherapy

• Registration Number: NCT02916511
• Lead Sponsor: Fudan University

Brief Summary

The purpose of this study is to evaluate safety and 2-year local control rate for extensive clinical target volumes in postoperative radiotherapy concurrent with chemotherapy for esophageal squamous cell carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Primary Completion: 2021-07-01
• Study Completion: 2023-07-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 • Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL< 1.5 x ULN • Renal function: creatinine < 1.5 x ULN
• No immuno-deficiency;
• Use of an effective contraceptive for adults to prevent pregnancy.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemo-radiation group	Radiotherapy	A total dose of 45Gy will be delivered in 25 fractions at 1.8Gy/fraction, 5 fractions per week in 5 weeks. The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and celiac nodes. Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw\*5
Chemo-radiation group	Paclitaxel	A total dose of 45Gy will be delivered in 25 fractions at 1.8Gy/fraction, 5 fractions per week in 5 weeks. The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and celiac nodes. Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw\*5
Chemo-radiation group	Carboplatin	A total dose of 45Gy will be delivered in 25 fractions at 1.8Gy/fraction, 5 fractions per week in 5 weeks. The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and celiac nodes. Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw\*5

Primary Outcome Measures

Name	Time	Method
Local control rate	2 years

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years

Trial Locations

Locations (1)

Fudan Universtiy Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China