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

NCT ID: NCT04764227

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-30
• Study Completion Date: 2027-03-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw\*5

Carboplatin

Intervention Type: DRUG

carboplatin AUC=2, ivgtt, d1, qw\*5

Radiotherapy

Intervention Type: RADIATION

1.8Gy/d, d1-5/week, 28Fx

Interventions

Paclitaxel

paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw\*5

Intervention Type: DRUG

Carboplatin

carboplatin AUC=2, ivgtt, d1, qw\*5

Intervention Type: DRUG

Radiotherapy

1.8Gy/d, d1-5/week, 28Fx

Intervention Type: RADIATION

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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Kuai Le Zhao, MD

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kuaile Zhao

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Countries

China

Other Identifiers

ESO- Shanghai 17

Identifier Type: -

Identifier Source: org_study_id