Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma (ESO-Shanghai9)

Fudan University

Status and phase: Completed; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02916511

ESO-Shanghai9

Details and patient eligibility

About

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.

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)

---

70 participants in 1 patient group

Chemo-radiation group

Experimental group

Description:

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

Treatment:

Radiation: Radiotherapy

Drug: Carboplatin

Drug: Paclitaxel