Comparable Study of Different Radiation Dose in Esophageal Carcinoma

Esophageal Carcinoma Clinical Trial

Official title:

A Prospective, Randomised Phase 3 Study of High-dose Versus Standard-dose Radiation of Inoperable Esophageal Carcinoma Treated With Concurrent Chemoradiation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01937208
• Other study ID #: ESC-130825
• Status: Recruiting
• Phase: Phase 3
• First received: August 25, 2013
• Last updated: September 3, 2013
• Start date: August 2013
• Est. completion date: July 2017

Study information

• Verified date: September 2013
• Source: Zhejiang Cancer Hospital
• Contact: xiao zheng, MD
• Phone: 0086-571-88122078
• Email: zhengxiao[@]medmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Radiation therapy plus concurrent chemotherapy is now the standard therapy for patients with localized carcinoma of the esophagus selected for nonsurgical treatment. The standard radiation dose is 50-50.4Gy/1.8-2.0Gy/F.All of this were based on 2D radiation technology. Entering new century, 3D-CRT or IMRT has used on esophageal cancer. In China,the recommend radiation dose of concurrent chemoradiation was 60Gy. The study is a clinical phase III, randomized trial to compare the different radiation dose(60Gy vs 50Gy) of concurrent chemoradiation using 3D-CRT or IMRT in patients with unresectable esophageal carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histological or cytologic diagnosis of esophageal carcinoma

• ECOG performance status 0-1

• Age:18-70 years

• Joined the study voluntarily and signed informed consent form

• Patients must not have received any prior anticancer therapy

• Unresectable disease, or refuse surgery.Stage ?-?A(AJCC 2009)

• Target lesions can be measured according to RECIST criteria

• No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin =9 g/dL, WBC=3x109/L, Neutrophils (ANC )=1.5x109/L, platelet count =100x 109/L, TBIL<1.5 x ULN, ALT and AST ? 2.5 x ULN, creatinine ? 1.5 x ULN

• Use of an effective contraceptive for adults to prevent pregnancy

• Life expectancy of more than 3 months

Exclusion Criteria:

• Multiple carcinomas of the esophagus,

• Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula,

• Metastatic disease (M1),

• A primary tumor that extended to within 2 cm of the gastroesophageal junction,

• Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor,

• Concurrent pregnancy or lactation, history of a second malignancy other than nonmelanoma skin cancer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Carcinoma
• Esophageal Neoplasms

Intervention

Radiation:
• intensity modulated radiation therapy in both arms

Drug:
• concurrent chemotherapy with radiation
docetaxel plus cisplatin were used weekly in both arms

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	local control rate; relapse location; toxicity		5 years	Yes
Other	radiation-related advent events		at least 3 years	Yes
Primary	Progression-free survival		5 years	Yes
Secondary	Overall survival		5 years	Yes