Esophageal NeoplasmsPhase 2NCT01693432
Docetaxel and S-1 for Advanced Esophageal Cancer
A Phase 2 study testing DS (docetaxel+S-1) in people with Esophageal Neoplasms, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
This study will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean patients with esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- DS (docetaxel+S-1)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Jun 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hallym University Medical Center
Anyang
Dae Young Zang, MD, PhD, 82313803871, fhdzang@hallym.or.kr
Jin Hee Jung, RN, 82313803704, jhjung23@daum.net
About this study
Official title: A Phase II Study of Docetaxel and S-1 as First-line Chemotherapy in Patients With Advanced Esophageal Cancer
This study will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean patients with esophageal cancer.
Read the 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.
- Conditions
- Esophageal Neoplasms
- Being tested
- DS (docetaxel+S-1)
- Keywords
- Esophageal neoplasms, Docetaxel, S-1
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS (docetaxel+S-1)Drug
Also called Taxotere, TS-1
Treatment will be delivered as a 3-week cycle.
- Docetaxel 60 mg/m²IV on day 1
- S-1 80 mg/m2/day PO on day 1-14
| Study group | Role | What they receive |
|---|---|---|
| DS (docetaxel+S-1) | Experimental | Treatment will be delivered as a 3-week cycle.
1. Docetaxel 60 mg/m²IV on day 1
2. S-1 80 mg/m2/day PO on day 1-14 Receives: Drug: DS (docetaxel+S-1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
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.
Measured: 1.5 years
Secondary outcomes (4)
Progression free survival
Progression free survival time will be measured from the start of study treatment until documented tumor progression, or death due to any cause
Measured: 1.5 years
Overall survival
Overall survival time will be measured from the start of study treatment until death due to any cause
Measured: 1.5 years
Toxicity profiles
adverse events will be descripted and graded using NCI-CTCAE version 4.0
Measured: 1.5 years
Disease control rate
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.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Dae Young Zang, MD, PhD, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693432
- Sponsor's protocol ID
- HMC-HO-GI-1202
- Status last verified
- Aug 2017
- First submitted
- 20 Sep 2012
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Docetaxel and S-1 as First-line Chemotherapy in Patients With Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01693432
- Acronym / sponsor ID
- HMC-HO-GI-1202
- Conditions
- Esophageal Neoplasms
- Keywords
- Esophageal neoplasms, Docetaxel, S-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
- Study start
- Nov 2011
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 26 Sep 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 will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean patients with esophageal cancer.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DS (docetaxel+S-1) | Experimental | Drug: DS (docetaxel+S-1)Treatment will be delivered as a 3-week cycle. 1. Docetaxel 60 mg/m²IV on day 1 2. S-1 80 mg/m2/day PO on day 1-14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS (docetaxel+S-1)Also: Taxotere, TS-1Treatment will be delivered as a 3-week cycle. 1. Docetaxel 60 mg/m²IV on day 1 2. S-1 80 mg/m2/day PO on day 1-14 | Drug | DS (docetaxel+S-1) |
Primary outcome
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.
4 secondary outcomes
Progression free survival
Time frame: 1.5 years
Overall survival
Time frame: 1.5 years
Toxicity profiles
Time frame: 1.5 years
Disease control rate
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Dae Young Zang, MD, PhD principal investigator
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DS (docetaxel+S-1) in people with Esophageal Neoplasms, run by Hallym University Medical Center 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 9 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: status not confirmed, as of the sponsor's last update on 23 Aug 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dae Young Zang, MD, PhD (82313803871, fhdzang@hallym.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 1.5 years). 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 23 Aug 2017.