Clinical trial NCT01640860: Concurrent Chemoradiotherapy With Docetaxel and Cisplatin in Esophageal Cancer
Official title: A Phase II Study of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin in Inoperable Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: docetaxel
cisplatin
combined modality therapy
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2012-07-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: advanced esophageal cancer diagosed at Chonnam National University Hospital

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 18\<age\<75 years
2. histologically proven and previously untreated SCC of the esophagus
3. WHO performance status(PS)≤2
4. absolute neutrophil count≥2,000/uL, platelet count≥100,000/uL
5. adequate renal and hepatic function
6. No prior chemotherapy but prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed
7. No prior radiation therapy for at least 4 weeks before enrollment in the study

Exclusion Criteria:

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

Primary outcomes:
measure: Response rate
timeFrame: 4-6 weeks after completion of CRT
Secondary outcomes:
measure: progression free survival, overall survival and adverse events
timeFrame: every 3-6 months
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeolanamdo
Study officials:
affiliation: CNUHH
name: Sang-Hee Cho, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: