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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04764227
• Other study ID #: ESO- Shanghai 17
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 30, 2020
• Est. completion date: March 30, 2027

Study information

• Verified date: August 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: March 30, 2027
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Chemoradiotherapy
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Esophagus Cancer
• Postoperative
• Radiation Therapy

Intervention

Drug:
• Paclitaxel
paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5
• Carboplatin
carboplatin AUC=2, ivgtt, d1, qw*5

Radiation:
• Radiotherapy
1.8Gy/d, d1-5/week, 28Fx

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control rate		2 years
Secondary	Overall survival		5 years