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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

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.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: S-1 oxaliplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2010
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: SOX: advanced BTC or ampullary carcinoma
unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma receive SOX regimen
Drug: S-1 oxaliplatin
S-1 (20mg, 25mg); L-OHP (50 mg)
Other Name: S-1 (20mg, 25mg); L-OHP (50 mg)

Primary Outcome Measures :
  1. objective response rate [ Time Frame: 2 years ]
    to evaluate objective response rate (ORR) of SOX regimen to BTC (Ampullary Adenocarcinoma)

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01180153

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Contact: Jie Li, Doctor 010-88121122 ext 321

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China, Beijing
Chin Beijing Cancer Hospital
Beijing, Beijing, China, 100004
Contact: Jie Li, Doctor    010-88121122 ext 321   
Contact: Yi Shen    010-59714220   
Principal Investigator: Lin Shen, Professor         
Sponsors and Collaborators
Beijing Cancer Hospital
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Principal Investigator: Lin Shen, Professor Beijing Cancer Hospital
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Responsible Party: Lin Shen, Beijing Cancer Hospital Identifier: NCT01180153    
Other Study ID Numbers: ChinaBJCH_SOX_BTC
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: August 12, 2010
Last Verified: August 2010
Keywords provided by Beijing Cancer Hospital:
40 S-1/L-OHP
biliary tract
ampullary carcinoma
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Antineoplastic Agents