Comparable Study of Different Radiation Dose in Esophageal Carcinoma

NCT ID: NCT01937208

Last Updated: 2013-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2017-07-31

Brief 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.

Conditions

Esophageal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

intensity modulated radiation therapy in both arms

Intervention Type: RADIATION

concurrent chemotherapy with radiation

Intervention Type: DRUG

docetaxel plus cisplatin were used weekly in both arms

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

Group Type: ACTIVE_COMPARATOR

intensity modulated radiation therapy in both arms

Intervention Type: RADIATION

concurrent chemotherapy with radiation

Intervention Type: DRUG

docetaxel plus cisplatin were used weekly in both arms

Interventions

intensity modulated radiation therapy in both arms

Intervention Type: RADIATION

concurrent chemotherapy with radiation

docetaxel plus cisplatin were used weekly in both arms

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiao Zheng, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

xiao zheng, MD

Role: CONTACT

zhengxiao@medmail.com

0086-571-88122078

ming chen, PHD

Role: CONTACT

chenming@sysucc.org.cn

0086-571-88122068

Facility Contacts

xiao zheng, MD

Role: primary

zhengxiao@medmail.com

0086-571-88122078

Other Identifiers

ESC-130825

Identifier Type: -

Identifier Source: org_study_id