Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma

Phase 2

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Radiation: radiation

• Registration Number: NCT02384811
• Lead Sponsor: Fudan University

Brief Summary

The primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-10
• Primary Completion: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-04
• Last Update Posted: 2017-09-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• 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≥3x109/L, Neutrophils (ANC )≥1.5x109/L • platelet count (Pt) ≥100x 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
Radiation group	radiation	Radiation therapy

Primary Outcome Measures

Name	Time	Method
Local control rate	2 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 year
Safety: Frequencies of treatment-related adverse event categories by NCI-CTC	3 months	Frequencies of treatment-related adverse event categories by NCI-CTC including Esophagitis,Pneumonitis/Bronchitis,Skin reaction in radiation fields,Nausea/vomiting,Leucopenia,Thrombocytopenia,Anemia,Fatigue.

Trial Locations

Locations (2)

Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Cancer hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China