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Study of S-1 Oxaliplatin (SOX) for Biliary Tract Cancer (BTC) (Ampullary Adenocarcinoma)

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. Read our disclaimer for details. Identifier: NCT01180153
Recruitment Status : Unknown
Verified August 2010 by Beijing Cancer Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 12, 2010
Last Update Posted : August 12, 2010
Information provided by:
Beijing Cancer Hospital

Tracking Information
First Submitted Date  ICMJE August 9, 2010
First Posted Date  ICMJE August 12, 2010
Last Update Posted Date August 12, 2010
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
objective response rate [ Time Frame: 2 years ]
to evaluate objective response rate (ORR) of SOX regimen to BTC (Ampullary Adenocarcinoma)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
overall survival [ Time Frame: 2 years ]
to evaluate survival data of overall survival (OS),Progression free Survival(PFS), safety outcome of SOX regimen to BTC (Ampullary Adenocarcinoma)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of S-1 Oxaliplatin (SOX) for Biliary Tract Cancer (BTC) (Ampullary Adenocarcinoma)
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Biliary Tract Cancer
Intervention  ICMJE Drug: S-1 oxaliplatin
S-1 (20mg, 25mg); L-OHP (50 mg)
Other Name: S-1 (20mg, 25mg); L-OHP (50 mg)
Study Arms  ICMJE Experimental: SOX: advanced BTC or ampullary carcinoma
unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma receive SOX regimen
Intervention: Drug: S-1 oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 11, 2010)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2012
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01180153
Other Study ID Numbers  ICMJE ChinaBJCH_SOX_BTC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lin Shen, Beijing Cancer Hospital
Study Sponsor  ICMJE Beijing Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lin Shen, Professor Beijing Cancer Hospital
PRS Account Beijing Cancer Hospital
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP