- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01640860
Concurrent Chemoradiotherapy With Docetaxel and Cisplatin in Esophageal Cancer
July 16, 2012 updated by: Sang-Hee Cho, Chonnam National University Hospital
A Phase II Study of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin in Inoperable Esophageal Cancer
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Chemotherapy can provide significant palliation of symptoms for patients with unresectable, locally advanced or metastatic esophageal cancer.
Cisplatin and continuous infusion 5 FU, alone or combined with radiotherapy, is the most frequently used regimen.
The response rate reported with cisplatin and 5 FU ranged from 35 to 40% ,whereas the 2-year survival rates of patients with locally advanced esophageal cancer ranged from 8 to 55%, with a mean 27%.
Therefore, there is a need to test new combination, specifically in unresectable locally advanced esophageal patients, with the aim of increasing the pCR rate and survival.
Cisplatin had been widely used as radiosensitizer and Docetaxel is different from that of cisplatin -5FU and and has proved to have an additive effect with cisplatin and supra-additive antitumor activity with fluorouracil in vitro and in murine models.
To investigate the feasibility of combining concomitant radiation with docetaxel and cisplatin and assess the regimen's toxicity, locoregional control rate, and survival in patients with locally advanced or metastatic esophageal cancer.In this study, docetaxel 25mg/m2 is given with 500ml normal saline , as a 1hr infusion, on days 1,8 of every 3 weeks.
Cisplatin75mg/m2 is given by intravenous infusion in 500 mL of 5% dextrose solution over 60 minutes on day 1 of every 3weeks.. Therapy will be repeated every 21 days.
Radiation therapy (200cGy/day upto 5400 cGy) begin on the first day of week 1 over 6 weeks (concomitant chemoradiation therapy).
When the investigators assume that standard treatment's response rate is 50% and the response of experimental treatment is 75% and use Simon's two-stage optimal design under the significance level of 5% and the power of 80%, the total sample size of 25 is at least required.
For a total of 25 subjects, 11 will be accrued during stage 1 and 14 during stage 2. If 6 or fewer responses are observed during the first stage then the trial is stopped early.
If 16 or fewer responses are observed by the end of the trial then no further investigation of the drug is warranted.
If the investigators assumed that the drop out rate was 10%, number of subjects per treatment arm will be 28.
Study Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jeolanamdo
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Hwasun, Jeolanamdo, Korea, Republic of, 519-809
- Chonnam National University Hwasun Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
advanced esophageal cancer diagosed at Chonnam National University Hospital
Description
Inclusion Criteria:
- 18<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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: 4-6 weeks after completion of CRT
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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.
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4-6 weeks after completion of CRT
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression free survival, overall survival and adverse events
Time Frame: every 3-6 months
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Tumor resection with extended en bloc lymphadenectomy was performed in operable patients approximately 4 to 8 weeks after treatment.
Follow-up evaluation was performed every 3months for the first 2years, then every 6monhs for the next 3 years, then annually until patinet death or loss to follow-up.
This included clinical examination, dysphagia score, assessment of late radiation toxicity and repeat CT scan of chest/ abdomen and EGD.
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every 3-6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sang-Hee Cho, MD. PhD, CNUHH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
January 7, 2008
First Submitted That Met QC Criteria
July 12, 2012
First Posted (Estimate)
July 16, 2012
Study Record Updates
Last Update Posted (Estimate)
July 17, 2012
Last Update Submitted That Met QC Criteria
July 16, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCESO
- CUNHH (Other Identifier: CNUHH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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