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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Beijing Cancer Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Beijing Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01180153
First received: August 9, 2010
Last updated: August 11, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Biliary Tract Cancer
Drug: S-1 oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Beijing Cancer Hospital:

Primary Outcome Measures:
  • objective response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    to evaluate objective response rate (ORR) of SOX regimen to BTC (Ampullary Adenocarcinoma)


Secondary Outcome Measures:
  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    to evaluate survival data of overall survival (OS),Progression free Survival(PFS), safety outcome of SOX regimen to BTC (Ampullary Adenocarcinoma)


Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180153

Contacts
Contact: Jie Li, Doctor 010-88121122 ext 321 xiaotong10241@sina.com

Locations
China, Beijing
Chin Beijing Cancer Hospital Not yet recruiting
Beijing, Beijing, China, 100004
Contact: Jie Li, Doctor    010-88121122 ext 321    xiaotong10241@sin.com   
Contact: Yi Shen    010-59714220    ian97@163.com   
Principal Investigator: Lin Shen, Professor         
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
Principal Investigator: Lin Shen, Professor Beijing Cancer Hospital
  More Information

No publications provided

Responsible Party: Lin Shen, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT01180153     History of Changes
Other Study ID Numbers: ChinaBJCH_SOX_BTC
Study First Received: August 9, 2010
Last Updated: August 11, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Cancer Hospital:
40 S-1/L-OHP
biliary tract
ampullary carcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Biliary Tract Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014