Efficacy and Safety Study of a Modified SOX Regimen in First-Line Treatment of Unresectable Gastric Adenocarcinoma (mSOX)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Sixth Affiliated Hospital, Sun Yat-sen University.
Recruitment status was: Recruiting
Information provided by (Responsible Party):
Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University
First received: March 6, 2012
Last updated: March 27, 2012
Last verified: March 2012
This is an open-label, phase II study to evaluate the efficacy and safety of a modified regimen of oxaliplatin and S-1 on unresectable gastric adenocarcinoma in the first-line therapy.
Drug: S-1 and Oxaliplatin
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Trial Evaluate a Modified SOX Regimen in First-Line Treatment of Unresectable Gastric Adenocarcinoma
Primary Outcome Measures:
- Overall response rate according to RECIST 1.1 [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Time to progression [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- overall survival [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- safety data of this regimen [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2013 (Final data collection date for primary outcome measure)
Drug: S-1 and Oxaliplatin
Oxaliplatin 85mg/m2 D1 and S-1 40mg/m2 BID D1-D10, repeat every two weeks;
Efficacy will be evaluated every three cycles.
Primary endpoint: Overall Response Rate
Secondary endpoint: Time to progression, overall survival, safety data
|Ages Eligible for Study:
||18 Years to 75 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Brain metastases;
- Female of childbearing potential, pregnancy test is positive;
- Concomitant malignancies or previous malignancies other than colorectal cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer;
- Active infection;
- Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk;
- Sexually active patients refusing to practice adequate contraception;
- Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator;
- History of grade 3 or 4 toxicity to fluoropyrimidines;
- Pre-existing neuropathy ≥ NCI CTC grade 2.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01552980
|Sixth Affiliated Hospital of Sun Yat-sen University
|Guangzhou, Guangdong, China, 510655 |
Sixth Affiliated Hospital, Sun Yat-sen University
||Sixth Affiliated Hospital, Sun Yat-sen University
||Jian Xiao, Principal Investigator, Sixth Affiliated Hospital, Sun Yat-sen University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 6, 2012
||March 27, 2012
||China: Ethics Committee
Keywords provided by Sixth Affiliated Hospital, Sun Yat-sen University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2016
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type