Comparable Study of Different Radiation Dose in Esophageal Carcinoma

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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Carcinoma
• Intervention / Treatment: Radiation: intensity modulated radiation therapy in both arms; Drug: concurrent chemotherapy with radiation

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: xiao zheng, MD; Phone Number: 0086-571-88122078; Email: zhengxiao@medmail.com
• Study Contact Backup: Name: ming chen, PHD; Phone Number: 0086-571-88122068; Email: chenming@sysucc.org.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: xiao zheng, MD; Phone Number: 0086-571-88122078; Email: zhengxiao@medmail.com
      • Principal Investigator: Ming Chen, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Ⅰ-ⅣA（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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high-dose; concurrent chemoradiation:CT:DDP 25mg/m2 D1+docetaxel 25mg/m2 D1,Weekly for 5 wks;RT：60Gy/30F/6W(3D-CRT or IMRT).Then,2 cycles consolidation chemotherapy were used:DDP 75mg/m2 D1+docetaxel 75mg/m2 D1, Q3W	Radiation: intensity modulated radiation therapy in both arms; Drug: concurrent chemotherapy with radiation; docetaxel plus cisplatin were used weekly in both arms
Active Comparator: standard dose; concurrent chemoradiation:CT:DDP 25mg/m2 D1+Docetaxel 25mg/m2 D1,Weekly for 5 wks;RT：50Gy/25F/5W(3D-CRT or IMRT).Then,2 cycles consolidation chemotherapy were used:DDP 5mg/m2 D1+Docetaxel75mg/m2 D1, Q3W	Radiation: intensity modulated radiation therapy in both arms; Drug: concurrent chemotherapy with radiation; docetaxel plus cisplatin were used weekly in both arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	5 years

Other Outcome Measures

Outcome Measure	Time Frame
local control rate; relapse location; toxicity	5 years
radiation-related advent events	at least 3 years

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Xiao Zheng, MD, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: August 25, 2013
• First Submitted That Met QC Criteria: September 3, 2013
• First Posted (Estimate): September 9, 2013

Study Record Updates

• Last Update Posted (Estimate): September 9, 2013
• Last Update Submitted That Met QC Criteria: September 3, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: chemoradiation; Esophageal Carcinoma; radiation dose
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Carcinoma; Esophageal Neoplasms
• Other Study ID Numbers: ESC-130825