Study of S-1 Oxaliplatin (SOX) for Biliary Tract Cancer (BTC) (Ampullary Adenocarcinoma)
Primary Purpose
Biliary Tract Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S-1 oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Cancer focused on measuring 40 S-1/L-OHP, biliary tract, ampullary carcinoma
Eligibility Criteria
Inclusion Criteria:
- Informed consent has been signed by the subject itself;
- Aged over 18;
- With a definite pathological or cytological diagnosis of adenocarcinoma;
- No pre-treatment (including radiotherapy, chemotherapy, immunotherapy, etc.). For recurrent cases, if the subjects have received adjuvant chemotherapy without S-1 or L-OHP after surgery and the time to the end date of adjuvant chemotherapy is over 6 months, they can also be enrolled;
- Enhanced helical CT or MRI scanning shows a target lesion over 1cm within 14 days before enrollment
Within 7 days before enrollment, baseline blood routine and biochemical indicators meet the following criteria:
- Hemoglobin ≥ 90g/L,
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L,
- Platelets ≥ 100×109/L,
- Serum total bilirubin < 1.5 times of the upper normal limit,
- Serum creatinine < upper limit of normal,
- Serum albumin ≥ 30 g/L;
- Can receive oral administration;
- Karnofsky(KPS) score ≥ 70 points;
- Expected survival time is more than 90 days;
- Women of childbearing age must receive urine or blood pregnancy test within 7 days before randomization and the results are negative;
- Male and female patients of appropriate reproductive age are willing to use reliable contraception methods for contraception in the process of study till 30 days after drug withdrawal.
Exclusion Criteria:
- Patients with a severe drug allergy history (including mildly allergic to L-OHP, 5-FU, FT207, 5-HT3 receptor antagonist);
- Patients who participated or are participating in other clinical trials within 4 weeks before enrollment;
- Patients who have received blood transfusion, blood products and hematopoietic factor preparations such as G-CSF within 15 days before enrollment;
- Patients who have undergone a surgery within 15 days before enrollment, and its effects have not been eliminated;
- Patients with diarrhea;
- Patients with a complication of active infection (infection causes a fever above 38 ℃);
- Patients accompanied by dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding and perforation, etc. that cause difficulty in taking S-1 orally;
- Patients with severe liver disease (e.g. active hepatitis, cirrhosis, etc.), renal insufficiency, severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.), or uncontrollable diabetes, hypertension and other chronic systemic diseases;
- Patients who have received long-term systemic steroid therapy (Note: short-term users with steroid withdrawal > 2 weeks can be selected);
- Patients with brain metastases or suspected of brain metastases;
- Patients with peripheral nervous system disorder or a history of significant mental disorder and central nervous system disorder;
- Heart disease of significant clinical symptoms, e.g. congestive heart failure, coronary heart disease with significant symptoms, arrhythmia and hypertension that are difficult to be controlled by drugs, or with an episode of myocardial infarction within 6 months, or cardiac insufficiency;
- Patients with pleural effusion, ascites, or pericardial effusion that needs drainage;
- Pregnant or breast-feeding women, or male and female patients of appropriate reproductive age who refuse to take contraceptive measures;
- Patients who have suffered from other malignancies within 5 years, except basal cell carcinoma and carcinoma in situ of uterine cervix that have already been cured;
- Patients without legal capability, or who can not continue the study due to medical or ethical reasons;
- Patients who are determined not suitable to participate in this clinical trial by the investigators.
Sites / Locations
- Chin Beijing Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SOX: advanced BTC or ampullary carcinoma
Arm Description
unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma receive SOX regimen
Outcomes
Primary Outcome Measures
objective response rate
to evaluate objective response rate (ORR) of SOX regimen to BTC (Ampullary Adenocarcinoma)
Secondary Outcome Measures
overall survival
to evaluate survival data of overall survival (OS),Progression free Survival(PFS), safety outcome of SOX regimen to BTC (Ampullary Adenocarcinoma)
Full Information
NCT ID
NCT01180153
First Posted
August 9, 2010
Last Updated
August 11, 2010
Sponsor
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT01180153
Brief Title
Study of S-1 Oxaliplatin (SOX) for Biliary Tract Cancer (BTC) (Ampullary Adenocarcinoma)
Official Title
An Pilot Study of S-1 Combined With Oxaliplatin for First-line Treatment of Unresectable, Metastatic or Locally Advanced Biliary Tract Cancer or Ampullary Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Peking University Cancer Hospital & Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate efficacy and safety of S-1 Oxaliplatin (SOX) regimen to patients with unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma.
Detailed Description
To list in cases with unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma that have not been treated before,confirm the efficacy and safety of combined S-1/L-OHP regimen for the biliary tract or ampullary carcinoma, providing evidence-based proof for the future treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer
Keywords
40 S-1/L-OHP, biliary tract, ampullary carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SOX: advanced BTC or ampullary carcinoma
Arm Type
Experimental
Arm Description
unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma receive SOX regimen
Intervention Type
Drug
Intervention Name(s)
S-1 oxaliplatin
Other Intervention Name(s)
S-1 (20mg, 25mg); L-OHP (50 mg)
Intervention Description
S-1 (20mg, 25mg); L-OHP (50 mg)
Primary Outcome Measure Information:
Title
objective response rate
Description
to evaluate objective response rate (ORR) of SOX regimen to BTC (Ampullary Adenocarcinoma)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
overall survival
Description
to evaluate survival data of overall survival (OS),Progression free Survival(PFS), safety outcome of SOX regimen to BTC (Ampullary Adenocarcinoma)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent has been signed by the subject itself;
Aged over 18;
With a definite pathological or cytological diagnosis of adenocarcinoma;
No pre-treatment (including radiotherapy, chemotherapy, immunotherapy, etc.). For recurrent cases, if the subjects have received adjuvant chemotherapy without S-1 or L-OHP after surgery and the time to the end date of adjuvant chemotherapy is over 6 months, they can also be enrolled;
Enhanced helical CT or MRI scanning shows a target lesion over 1cm within 14 days before enrollment
Within 7 days before enrollment, baseline blood routine and biochemical indicators meet the following criteria:
Hemoglobin ≥ 90g/L,
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L,
Platelets ≥ 100×109/L,
Serum total bilirubin < 1.5 times of the upper normal limit,
Serum creatinine < upper limit of normal,
Serum albumin ≥ 30 g/L;
Can receive oral administration;
Karnofsky(KPS) score ≥ 70 points;
Expected survival time is more than 90 days;
Women of childbearing age must receive urine or blood pregnancy test within 7 days before randomization and the results are negative;
Male and female patients of appropriate reproductive age are willing to use reliable contraception methods for contraception in the process of study till 30 days after drug withdrawal.
Exclusion Criteria:
Patients with a severe drug allergy history (including mildly allergic to L-OHP, 5-FU, FT207, 5-HT3 receptor antagonist);
Patients who participated or are participating in other clinical trials within 4 weeks before enrollment;
Patients who have received blood transfusion, blood products and hematopoietic factor preparations such as G-CSF within 15 days before enrollment;
Patients who have undergone a surgery within 15 days before enrollment, and its effects have not been eliminated;
Patients with diarrhea;
Patients with a complication of active infection (infection causes a fever above 38 ℃);
Patients accompanied by dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding and perforation, etc. that cause difficulty in taking S-1 orally;
Patients with severe liver disease (e.g. active hepatitis, cirrhosis, etc.), renal insufficiency, severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.), or uncontrollable diabetes, hypertension and other chronic systemic diseases;
Patients who have received long-term systemic steroid therapy (Note: short-term users with steroid withdrawal > 2 weeks can be selected);
Patients with brain metastases or suspected of brain metastases;
Patients with peripheral nervous system disorder or a history of significant mental disorder and central nervous system disorder;
Heart disease of significant clinical symptoms, e.g. congestive heart failure, coronary heart disease with significant symptoms, arrhythmia and hypertension that are difficult to be controlled by drugs, or with an episode of myocardial infarction within 6 months, or cardiac insufficiency;
Patients with pleural effusion, ascites, or pericardial effusion that needs drainage;
Pregnant or breast-feeding women, or male and female patients of appropriate reproductive age who refuse to take contraceptive measures;
Patients who have suffered from other malignancies within 5 years, except basal cell carcinoma and carcinoma in situ of uterine cervix that have already been cured;
Patients without legal capability, or who can not continue the study due to medical or ethical reasons;
Patients who are determined not suitable to participate in this clinical trial by the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Li, Doctor
Phone
010-88121122
Ext
321
Email
xiaotong10241@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Shen, Professor
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chin Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Li, Doctor
Phone
010-88121122
Ext
321
Email
xiaotong10241@sin.com
First Name & Middle Initial & Last Name & Degree
Yi Shen
Phone
010-59714220
Email
ian97@163.com
First Name & Middle Initial & Last Name & Degree
Lin Shen, Professor
12. IPD Sharing Statement
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Study of S-1 Oxaliplatin (SOX) for Biliary Tract Cancer (BTC) (Ampullary Adenocarcinoma)
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