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

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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