Docetaxel and S-1 for Advanced Esophageal Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Docetaxel and S-1 as First-line Chemotherapy in Patients With Advanced Esophageal Cancer|
- Objective response rate [ Time Frame: 1.5 years ]Objective response rate will be measured from the rate of complete response (disappearance of disease) and partial response (decrease at least 30% in the sum of the longest diameters of target lesions) by RECIST (response evaluation criteria in solid tumors) guidelines.
- Progression free survival [ Time Frame: 1.5 years ]Progression free survival time will be measured from the start of study treatment until documented tumor progression, or death due to any cause
- Overall survival [ Time Frame: 1.5 years ]Overall survival time will be measured from the start of study treatment until death due to any cause
- Toxicity profiles [ Time Frame: 1.5 years ]adverse events will be descripted and graded using NCI-CTCAE version 4.0
- Disease control rate [ Time Frame: 1.5 years ]Disease control rate will be measured from the rate of complete response (disappearance of disease), partial response (decrease at least 30% in the sum of the longest diameters of target lesions), and stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) by RECIST (response evaluation criteria in solid tumors) guidelines.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Experimental: DS (docetaxel+S-1)
Treatment will be delivered as a 3-week cycle.
Drug: DS (docetaxel+S-1)
Treatment will be delivered as a 3-week cycle.
Esophageal cancer is the ninth most common cancer in male population in Korea. It was estimated that 1,864 new cases of esophageal cancer were reported and 1,434 deaths occurred in Korea in 2005.
Although half of the patients with esophageal cancer initially present with locoregional disease amenable to radical surgery or radiation-based therapy, most patients eventually develop metastatic disease with or without local recurrence.
Chemotherapy plays a major role in palliative therapy and remains to be the primary mode of treatment for the recurrent or metastatic esophageal cancer. Although various chemotherapy regimens are available, esophageal cancer carries a very poor prognosis, with a mean survival time of less than 8.1 months with current chemotherapies used singly or in combination with 5-fluorouracil (5-FU), vindesine, mitomycin, docetaxel, paclitaxel, cisplatin, irinotecan, vinorelbine, or capecitabine. The majority of the trials performed were in small numbers of patients with reported response rates from 15 to 40%.
The response was usually of short duration and there was no survival benefit with single agent chemotherapy. Combination chemotherapy has slightly improved the results in terms of duration of response (3-6 months), but still there was little improvement in overall survival. Therefore, the identification of new active agents is essential to prolong the survival.
Clinical trials of single agent docetaxel have been reported in patients with esophageal cancer and the response rate is about 18-25%.
S-1, a new biochemical modulator of 5-FU, is an oral dihydropyrimidine dehydrogenase(DPD) inhibitory fluoropyrimidine. The advantages of S-1 compared with 5-FU are greater convenience because of its oral formulation and continuous delivery, without intravenous infusion. S-1 is frequently used as a substitute for 5-FU in gastric cancer, but limited data is available for esophageal cancer.
The combination of docetaxel and S-1 is highly active and well tolerated in advanced or recurrent gastric cancer, and the synergistic antitumor activity has been fully elucidated.
Therefore, we will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean patients with esophageal cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693432
|Contact: Dae Young Zang, MD, PhDfirstname.lastname@example.org|
|Contact: Jin Hee Jung, RNemail@example.com|
|Korea, Republic of|
|Hallym University Medical Center||Recruiting|
|Anyang, Korea, Republic of|
|Contact: Dae Young Zang, MD, PhD 82313803871 firstname.lastname@example.org|
|Contact: Jin Hee Jung, RN 82313803704 email@example.com|
|Sub-Investigator: Hyeong Su Kim, MD|
|Sub-Investigator: Boram Han, MD|
|Principal Investigator:||Dae Young Zang, MD, PhD||Hallym University Medical Center|