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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
objective response rate
Secondary Outcome
overall survival
Condition
Biliary Tract Cancer
Intervention
S-1 oxaliplatin
Study Arms / Comparison Groups
SOX: advanced BTC or ampullary carcinoma
Description: unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma receive SOX regimen
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
August 2010
Completion Date
August 2012
Primary Completion Date
August 2012
Eligibility Criteria
Inclusion Criteria:
1. Informed consent has been signed by the subject itself;
2. Aged over 18;
3. With a definite pathological or cytological diagnosis of adenocarcinoma;
4. 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;
5. Enhanced helical CT or MRI scanning shows a target lesion over 1cm within 14 days
before enrollment
6. 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;
7. Can receive oral administration;
8. Karnofsky(KPS) score ≥ 70 points;
9. Expected survival time is more than 90 days;
10. Women of childbearing age must receive urine or blood pregnancy test within 7 days
before randomization and the results are negative;
11. 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:
1. Patients with a severe drug allergy history (including mildly allergic to L-OHP, 5-FU,
FT207, 5-HT3 receptor antagonist);
2. Patients who participated or are participating in other clinical trials within 4 weeks
before enrollment;
3. Patients who have received blood transfusion, blood products and hematopoietic factor
preparations such as G-CSF within 15 days before enrollment;
4. Patients who have undergone a surgery within 15 days before enrollment, and its
effects have not been eliminated;
5. Patients with diarrhea;
6. Patients with a complication of active infection (infection causes a fever above 38
℃);
7. Patients accompanied by dysphagia, complete or incomplete gastrointestinal
obstruction, active gastrointestinal bleeding and perforation, etc. that cause
difficulty in taking S-1 orally;
8. 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;
9. Patients who have received long-term systemic steroid therapy (Note: short-term users
with steroid withdrawal > 2 weeks can be selected);
10. Patients with brain metastases or suspected of brain metastases;
11. Patients with peripheral nervous system disorder or a history of significant mental
disorder and central nervous system disorder;
12. 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;
13. Patients with pleural effusion, ascites, or pericardial effusion that needs drainage;
14. Pregnant or breast-feeding women, or male and female patients of appropriate
reproductive age who refuse to take contraceptive measures;
15. 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;
16. Patients without legal capability, or who can not continue the study due to medical or
ethical reasons;
17. Patients who are determined not suitable to participate in this clinical trial by the
investigators.
Gender
All
Ages
18 Years - 74 Years
Accepts Healthy Volunteers
No
Contacts
Lin Shen, Professor, 010-88121122, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01180153
Organization ID
ChinaBJCH_SOX_BTC
Study Sponsor
Beijing Cancer Hospital
Study Sponsor
Lin Shen, Professor, Principal Investigator, Beijing Cancer Hospital
Verification Date
August 2010