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

NCT01180153 | Unknown Phase 2 DMC

• 1 other identifier: ChinaBJCH_SOX_BTC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Cancer

Keywords

40 S-1/L-OHP; biliary tract; ampullary carcinoma

Outcome Measures

Primary Outcomes (1)

• objective response rate

  to evaluate objective response rate (ORR) of SOX regimen to BTC (Ampullary Adenocarcinoma)

  2 years

Secondary Outcomes (1)

• overall survival

  2 years

Study Arms (1)

SOX: advanced BTC or ampullary carcinoma

EXPERIMENTAL

unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma receive SOX regimen

Drug: S-1 oxaliplatin

Interventions

S-1 oxaliplatin DRUG

S-1 (20mg, 25mg); L-OHP (50 mg)

Also known as: S-1 (20mg, 25mg); L-OHP (50 mg)

SOX: advanced BTC or ampullary carcinoma

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent has been signed by the subject itself;
• Aged over 18;
• With a definite pathological or cytological diagnosis of adenocarcinoma;
• 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;
• Enhanced helical CT or MRI scanning shows a target lesion over 1cm within 14 days before enrollment
• 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;
• Can receive oral administration;
• Karnofsky(KPS) score ≥ 70 points;
• Expected survival time is more than 90 days;

You may not qualify if:

• Patients with a severe drug allergy history (including mildly allergic to L-OHP, 5-FU, FT207, 5-HT3 receptor antagonist);
• Patients who participated or are participating in other clinical trials within 4 weeks before enrollment;
• Patients who have received blood transfusion, blood products and hematopoietic factor preparations such as G-CSF within 15 days before enrollment;
• Patients who have undergone a surgery within 15 days before enrollment, and its effects have not been eliminated;
• Patients with diarrhea;
• Patients with a complication of active infection (infection causes a fever above 38 ℃);
• Patients accompanied by dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding and perforation, etc. that cause difficulty in taking S-1 orally;
• 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;
• Patients who have received long-term systemic steroid therapy (Note: short-term users with steroid withdrawal \> 2 weeks can be selected);
• Patients with brain metastases or suspected of brain metastases;
• Patients with peripheral nervous system disorder or a history of significant mental disorder and central nervous system disorder;
• 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;
• Patients with pleural effusion, ascites, or pericardial effusion that needs drainage;
• Pregnant or breast-feeding women, or male and female patients of appropriate reproductive age who refuse to take contraceptive measures;
• 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;

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Chin Beijing Cancer Hospital

Beijing, Beijing Municipality, 100004, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

S 1 (combination); Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Lin Shen, Professor

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Li, Doctor

CONTACT

010-88121122; xiaotong10241@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 12, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 12, 2010

Record last verified: 2010-08

Locations

CN (1)