Docetaxel and S-1 for Advanced Esophageal Cancer
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Neoplasms |
Drug: DS (docetaxel+S-1) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
- Toxicity profiles [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- Disease control rate [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 37 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pathologically confirmed squamous cell carcinoma or adenocarcinoma of esophagus.
- Unresectable locally advanced, recurrent or metastatic disease.
- Measurable or evaluable disease by RECIST criteria 1.1.
- Minimum age of 18 years.
- ECOG Performance status 0-2.
- Prior chemotherapy is not allowed.
- More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions are outside the radiation field)
- Adequate organ functions
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
Exclusion Criteria:
- Other tumor type than squamous cell carcinoma and adenocarcinoma
- Previous history of chemotherapy except neoadjuvant or adjuvant chemotherapy without docetaxel and S-1
- Obvious bowel obstruction unrelieved by proper management
- Evidence of serious gastrointestinal bleeding
- Patients with CNS metastases
- Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
- Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
- Known history of cerebral or leptomeningeal metastases or neurologic disease
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01693432
| Contact: Dae Young Zang, MD, PhD | 82313803871 | fhdzang@hallym.or.kr | |
| Contact: Jin Hee Jung, RN | 82313803704 | jhjung23@daum.net |
| Korea, Republic of | |
| Hallym University Medical Center | Recruiting |
| Anyang, Korea, Republic of | |
| Contact: Dae Young Zang, MD, PhD 82313803871 fhdzang@hallym.or.kr | |
| Contact: Jin Hee Jung, RN 82313803704 jhjung23@daum.net | |
| Sub-Investigator: Hyeong Su Kim, MD | |
| Sub-Investigator: Boram Han, MD | |
| Principal Investigator: | Dae Young Zang, MD, PhD | Hallym University Medical Center |
More Information
| Responsible Party: | Hallym University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01693432 History of Changes |
| Other Study ID Numbers: | HMC-HO-GI-1202 |
| Study First Received: | September 20, 2012 |
| Last Updated: | September 27, 2016 |
| Health Authority: | Korea: Food and Drug Administration |
| Individual Participant Data | |
| Plan to Share IPD: | Undecided |
Keywords provided by Hallym University Medical Center:
|
Esophageal neoplasms Docetaxel S-1 |
Additional relevant MeSH terms:
|
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases |
Gastrointestinal Diseases Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 28, 2016