Esophageal CancerNCT01640860
Concurrent Chemoradiotherapy With Docetaxel and Cisplatin in Esophageal Cancer
An observational study of Esophageal Cancer, run by Chonnam National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2007to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: advanced esophageal cancer diagosed at Chonnam National University Hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonnam National University Hwasun Hospital
Hwasun, Jeolanamdo, 519-809
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Cancer
- Keywords
- docetaxel, cisplatin, combined modality therapy
- Medical subject headings
- Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-6 weeks after completion of CRT
Secondary outcomes (1)
progression free survival, overall survival and adverse events
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.
Measured: every 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startDec 2007
- Primary completionDec 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Sang-Hee Cho, Chonnam National University Hospital
- Investigators
- Sang-Hee Cho, MD. PhD, Principal investigator, CNUHH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640860
- Sponsor's protocol ID
- DCESO
- Other IDs
- CUNHH
- Status last verified
- Jul 2012
- First submitted
- 7 Jan 2008
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin in Inoperable Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01640860
- Acronym / sponsor ID
- DCESO
- Conditions
- Esophageal Cancer
- Keywords
- docetaxel, cisplatin, combined modality therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Dec 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- advanced esophageal cancer diagosed at Chonnam National University Hospital
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Evidence of distant metastases
- Pleural of pericardial effusion
- Fistulisation
- Prior malignancies(other than basal cell skin carcinoma)
- Prior myocardial infarction or uncontrolled infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response rate
Time frame: 4-6 weeks after completion of CRT
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.
1 secondary outcome
progression free survival, overall survival and adverse events
Time frame: every 3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Hee Cho, MD. PhD principal investigator
CNUHH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Chonnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 4-6 weeks after completion of CRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012.