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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02384811
• Other study ID #: 2014-86-882
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 2, 2015
• Last updated: September 4, 2017
• Start date: December 2014
• Est. completion date: July 2019

Study information

• Verified date: September 2017
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: July 2019
• Est. primary completion date: July 2017
• 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=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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Radiation:
• radiation
A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks. The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai
China	Shanghai Cancer Center	Shanghai	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 year
Secondary	Safety: Frequencies of treatment-related adverse event categories by NCI-CTC	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.	3 months