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Comparable Study of Different Radiation Dose in Esophageal Carcinoma

NCT ID: NCT01937208

Last Updated: 2013-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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.

Detailed Description

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Conditions

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Esophageal Carcinoma

Keywords

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Esophageal Carcinoma chemoradiation radiation dose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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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

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiao Zheng, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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xiao zheng, MD

Role: CONTACT

Phone: 0086-571-88122078

Email: [email protected]

ming chen, PHD

Role: CONTACT

Phone: 0086-571-88122068

Email: [email protected]

Facility Contacts

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xiao zheng, MD

Role: primary

Other Identifiers

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ESC-130825

Identifier Type: -

Identifier Source: org_study_id