- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01811277
SOX Sequential S-1 in Advanced Biliary Tract Carcinoma(BTC)and Pancreatic Cancer
March 13, 2013 updated by: Shen Lin, Peking University
Phase II Exploratory Study of S-1 Combined With Oxaliplatin Sequential S-1 Single-agent First-line Treatment of Unresectable Metastatic or Locally Advanced Biliary System, Periampullary Cancer and Pancreatic Cancer
This is an exploratory, single-armed, open label study on the efficacy and safety of sequential S-1 therapy after SOX in unresectable metastatic or locally advanced biliary system or periampullary cancer or pancreatic cancer patients.
The primary endpoint is Objective response rate and secondary endpoint is progression free survival , overall survival ,1 year survival rate and safety.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lin Shen, Prof.
- Phone Number: +86 10 88196175
- Email: lin100@medmail.com.cn
Study Contact Backup
- Name: Jie Li, Prof.
- Phone Number: +86 10 88196561
- Email: xiaotong10241@sina.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
Contact:
- Lin Shen, Prof.
- Phone Number: +86 10 88196175
- Email: lin100@medmail.com.cn
-
Contact:
- Jie Li, Prof.
- Phone Number: +86 10 88196561
- Email: xiaotong10241@sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written Informed consent
- Male or female patients >=18 years old
- Histologically or cytologically confirmed diagnosis of adenocarcinoma
- No previous treatment is allowed including chemotherapy, radiotherapy,immunotherapy or others.
- In case the patient received adjuvant therapy before, enrollment is allowed if the adjuvant therapy does not contain L-OHP or S-1 and at the same time, the last day of chemotherapy is ≥180 days before screening.
- Target lesion more than 1cm in diameter by enhanced CT or MRI 21 days before enrollment
The laboratory parameter meets the following criteria 7 days before enrollment
- Hemoglobin ≥90g/L
- Absolute neutrophil count≥1.5×10^9/L, platelets 100×10^9/L;
- ALT and AST≤2.5 ULN(in case of the patients with liver metastasis,ALT and AST≤5.0 ULN)
- ALP ≤2.5 ULN (in case of the patients with liver metastasis,≤5.0 ULN)
- Total Serum bilirubin ≤1.5 ULN
- Serum creatinine ≤1.0 ULN
- serum albumin(ALB)≥30g/L;
- can tolerate oral drug administration;
- KPS ≥70
- Estimated survival ≥90 days
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of enrollment and must be willing to use adequate methods of contraception during the study and for 30 days after last study durg administration.
Exclusion Criteria:
- Known sensitivity to 5-HT3 antagonist and hypersensitivity to the other treatment agents including irinotecan, cisplatin and octreotide lar
- Any participation in trials simultaneously or 4 weeks before screening.
- 15 days prior to enrollment, received a blood transfusion, blood products and hematopoietic growth factors such as G-CSF.
- Undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery.
- Uncontrolled severe diarrhea
- Uncontrolled active infection (fever ≥38 degrees due to infection)
- S-1 oral drug administration difficulty due to difficulty swallowing, complete or incomplete digestive tract obstruction, gastrointestinal active bleeding, perforation;
- severe hepatopathy including active hepatitis and hepatic cirrhosis, renal dysfunction, severe pulmonary diseases including interstitial pneumonia, pulmonary fibrosis and severe pulmonary emphysema, uncontrolled diabetes, hypertension and other chronic systematic diseases.
- Chronic treatment with steroids.(In case of the patients with short-term use of steroids, the enrollment is permitted if the administration is stopped 2 weeks before screening.)
- confirmed or suspected CNS metastasis
- the history of peripheral nervous system impairment, obvious mental disorder or CNS impairment
- clinically significant heart disease, including congestive heart failure, symptomatic coronal heart disease, arrythmia uncontrolled by medication and acute myocardial infarction or cardiac insufficiency within 6 months before screening
- Drainage of pleural effusion, peritoneal effusion and pericardial effusion
- pregnant women or women in lactation period
- Fertile male or women of child-bearing potential refuse to take highly effective methods of birth control
- Incidence of other second primary malignant tumors within 5 years, except for cured basal cell carcinoma and cervical carcinoma in situ.
- patients of legal incapacity or who have the potential of influence the whole trial due to medical or ethic reasons.
- Other patients who are not eligible to the trial under investigators' discretion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SOX sequential S-1
4-6 cycles of SOX followed by S-1 monotherapy until disease progression
|
4-6 cycles SOX followed by S-1 monotherapy until disease progression S-1: 40~60mg bid,po, d1~14 (S-1:BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) oxaliplatin:130mg/m2,iv drip for 2h,d1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate for SOX sequential S-1
Time Frame: 1 years
|
The primary endpoint is objective response rate,which equals CR+PR.
|
1 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 2 years
|
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost
|
2 years
|
progression free survival
Time Frame: 1 year
|
PFS means that from the first dose of treatment drug to disease progression or death or lost, the follow-up visit will be performed every 6 weeks till progression or death or lost
|
1 year
|
1 year survival rate
Time Frame: 1 year
|
the follow-up visit of survival will be performed every 3 months till 1 year
|
1 year
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 2 years
|
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Anticipated)
July 1, 2014
Study Completion (Anticipated)
July 1, 2014
Study Registration Dates
First Submitted
March 11, 2013
First Submitted That Met QC Criteria
March 12, 2013
First Posted (Estimate)
March 14, 2013
Study Record Updates
Last Update Posted (Estimate)
March 15, 2013
Last Update Submitted That Met QC Criteria
March 13, 2013
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOX-S-1 BTC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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