Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)

Phase 2

Active, not recruiting

• Conditions: Esophagus Cancer; Chemoradiotherapy; Radiation Therapy; Esophageal Squamous Cell Carcinoma; Postoperative
• Interventions: Drug: Paclitaxel; Drug: Carboplatin; Radiation: Radiotherapy

• Registration Number: NCT04764227
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-30
• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-21
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03
• Primary Completion: 2024-03-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• 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
Concurrent chemoradiotherapy group	Radiotherapy	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.
Concurrent chemoradiotherapy group	Paclitaxel	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.
Concurrent chemoradiotherapy group	Carboplatin	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.

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 University Shanghai Cancer Center; 🇨🇳 Shanghai, China