Concurrent Chemoradiotherapy With Docetaxel and Cisplatin in Esophageal Cancer

NCT01640860 | Completed DMC

• 2 other identifiers: DCESOCUNHH
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determined the feasibility and safety in advanced esophageal cancer treated with docetaxel and cisplatin cocurrent chemoradiotherapy. The primary end points were clinical best response and response rate and secondary endpoints were progression free survival and overall survival.

Conditions

Esophageal Cancer

Keywords

docetaxel; cisplatin; combined modality therapy

Outcome Measures

Primary Outcomes (1)

• Response rate

  Chest and abdominal CT and EGD were obtained to assess tumor status, 4 to 6 weeks after the completion of CRT. The patients who were documented on the CT scan and upper gastrofibroscopy as showing a complete response (CR) underwent positron emission tomography (PET)-CT. If the PET-CT showed no metabolic evidence of malignancy, we deemed the response to be a CR.

  4-6 weeks after completion of CRT

Secondary Outcomes (1)

• progression free survival, overall survival and adverse events

  every 3-6 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

advanced esophageal cancer diagosed at Chonnam National University Hospital

You may qualify if:

• \<age\<75 years
• histologically proven and previously untreated SCC of the esophagus
• WHO performance status(PS)≤2
• absolute neutrophil count≥2,000/uL, platelet count≥100,000/uL
• adequate renal and hepatic function
• No prior chemotherapy but prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed
• No prior radiation therapy for at least 4 weeks before enrollment in the study

You may not qualify if:

• Evidence of distant metastases
• Pleural of pericardial effusion
• Fistulisation
• Prior malignancies(other than basal cell skin carcinoma)
• Prior myocardial infarction or uncontrolled infection
• Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
• History of significant neurologic or psychiatric disorders including dementia or seizures
• Other serious underlying medical conditions which could impair the ability of the patient to participate in the study

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• Sanofi: collaborator

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, Jeolanamdo, 519-809, South Korea

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Sang-Hee Cho, MD. PhD

  CNUHH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: July 16, 2012
• Study Start: December 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2011
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

KR (1)