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Comparable Study of Different Radiation Dose in Esophageal Carcinoma

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ClinicalTrials.gov Identifier: NCT01937208
Recruitment Status : Unknown
Verified September 2013 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : September 9, 2013
Last Update Posted : September 9, 2013
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Esophageal Carcinoma Radiation: intensity modulated radiation therapy in both arms Drug: concurrent chemotherapy with radiation Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomised Phase 3 Study of High-dose Versus Standard-dose Radiation of Inoperable Esophageal Carcinoma Treated With Concurrent Chemoradiation
Study Start Date : August 2013
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Other Outcome Measures:
  1. local control rate; relapse location; toxicity [ Time Frame: 5 years ]
  2. radiation-related advent events [ Time Frame: at least 3 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937208


Contacts
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Contact: xiao zheng, MD 0086-571-88122078 zhengxiao@medmail.com
Contact: ming chen, PHD 0086-571-88122068 chenming@sysucc.org.cn

Locations
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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: xiao zheng, MD    0086-571-88122078    zhengxiao@medmail.com   
Principal Investigator: ming chen, PHD         
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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Principal Investigator: Xiao Zheng, MD Zhejiang Cancer Hospital

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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01937208     History of Changes
Other Study ID Numbers: ESC-130825
First Posted: September 9, 2013    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: September 2013
Keywords provided by Zhejiang Cancer Hospital:
Esophageal Carcinoma
chemoradiation
radiation dose
Additional relevant MeSH terms:
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Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action