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

Fudan University

Status and phase: Active, not recruiting; Phase 2

Conditions: Radiation Therapy; Esophagus Cancer; Chemoradiotherapy; Esophageal Squamous Cell Carcinoma; Postoperative

Treatments: Radiation: Radiotherapy; Drug: Carboplatin; Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT04764227

ESO- Shanghai 17

Details and patient eligibility

About

The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Concurrent chemoradiotherapy group

Experimental group

Description:

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.

Treatment:

Drug: Carboplatin

Radiation: Radiotherapy

Drug: Paclitaxel