Docetaxel and S-1 for Advanced Esophageal Cancer
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01693432 |
|
Recruitment Status :
Recruiting
First Posted : September 26, 2012
Last Update Posted : August 23, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Neoplasms | Drug: DS (docetaxel+S-1) | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 37 participants |
| 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 |
| Study Start Date : | November 2011 |
| Estimated Primary Completion Date : | June 2018 |
| Estimated Study Completion Date : | June 2018 |
| Arm | Intervention/treatment |
|---|---|
|
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:
|
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Hallym University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01693432 History of Changes |
| Other Study ID Numbers: |
HMC-HO-GI-1202 |
| First Posted: | September 26, 2012 Key Record Dates |
| Last Update Posted: | August 23, 2017 |
| Last Verified: | August 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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 |