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QYHJ Granules Versus Xeloda in Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01796782
Recruitment Status : Unknown
Verified February 2013 by liu lu ming, Fudan University.
Recruitment status was:  Active, not recruiting
First Posted : February 22, 2013
Last Update Posted : February 22, 2013
Sponsor:
Information provided by (Responsible Party):
liu lu ming, Fudan University

Brief Summary:

Primary End Point:

- To compare the overall survival (OS) using QYHJ Granules or Xeloda as the second therapy in patients with metastatic pancreatic cancer.

Secondary End Points:

  • Compare clinical efficacy by other measures including PFS,tumor response,and changes in quality of life (QOL) between these two groups.
  • Examine the feasibility and assess the side effects of treatment using QYHJ Granules in patients with metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: Xeloda Drug: QYHJ Granules Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open-label, Phase II Study of QYHJ Granules Versus Xeloda in the Second-line Treatment of Patients With Metastatic Pancreatic Cancer
Study Start Date : January 2013
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Xeloda
Subjects will receive Xeloda until progression
Drug: Xeloda
Xeloda dose is calculated according to body surface area.The recommended dose is 1000 mg/m² administered orally twice daily (morning and evening; equivalent to 2000 mg/m² total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles
Other Name: Capecitabine

Experimental: QYHJ Granules
patients will receive QYHJ Granules until progression
Drug: QYHJ Granules
1-4 bags bid , days 1-42, every 6 weeks




Primary Outcome Measures :
  1. overall survival (OS) [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Progression free survival(PFS) [ Time Frame: up to 3 years ]
  2. Tumor response(ORR、DCR) [ Time Frame: up to 3 years ]
  3. Clinical benefit rate (CBR)and QOL assessment [ Time Frame: up to 3 years ]
  4. Number of adverse events of QYHJ Formula [ Time Frame: up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically/cytologically confirmed metastatic pancreatic adenocarcinoma.
  • Patients have failed from the prior chemotherapy without Xeloda. Adjuvant chemotherapy containing Xeloda and 6 months before recruitment is included.
  • Patients haven't taken QYHJ Granules before. Prior exposure to Traditional Chinese Medicine not based on QYHJ Formula is allowed provided that at least one week washout time is given prior to initiation of experimental treatment.
  • ECOG performance status 0, 1 or 2.
  • Measurable disease by RECIST criteria must be present. Bone scan abnormalities alone will not be accepted as measurable disease. Lytic lesions seen on plain radiographs will not be accepted as measurable disease but will be evaluated in conjunction with bone scan abnormalities. Pure blastic bone metastases will not be accepted as measurable disease. Pleural or peritoneal effusions will not be accepted as measurable disease. Irradiated lesions are not considered measurable.
  • Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
  • Patients must have adequate organ functions reflected by the laboratory criteria below: neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 85 g/L, Serum creatinine < 2.0 mg/dL, Bilirubin < 1.5 mg/dL, ALT < 3 x normal, albumin >30g/L.
  • Age ≥ 18.
  • Prior local therapy, e.g., TACE or radiation, is allowed provided that at least 4 weeks washout time is given.
  • Concomitant bisphosphonates are allowed for patients with bone metastases. Patients with jaundice must have a biliary drainage decompression operation before recruitment.
  • Ability to understand and the willingness to sign a written informed consent.
  • Subjects who have a life expectancy of at least 3 months.

Exclusion Criteria:

  • ECOG performance status 3 or 4.
  • Known central nervous system involvement and leptomeningeal disease.
  • Previous Xeloda-based chemotherapy (except usage for Adjuvant chemotherapy and 6 months before recruitment).
  • Prior treatment with QYHJ Granules.
  • Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV),unstable angina, myocardial infarction within the past six months, severe arrhythmia.
  • Concurrent infection requiring intravenous antibiotics, active HIV infection/HIV disease, psychiatric disorders, drug abuse.
  • Known allergies to the QYHJ or Xeloda.
  • Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. Men and women of childbearing potential not using effective means of contraception.
  • Known other non-adenocarcinoma pathological type.
  • Other primary tumour (including primary brain tumours) within the last 5 years prior to enrollment, except for adequately treated carcinoma in situ of the cervix or basal cell skin cancer.
  • Inability to take oral medication, prior surgical procedures affecting absorption or unwilling to take the Traditional Chinese Medicine.
  • Patiens who are suffering from diarrhea.
  • Subjects with poor compliance.

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 ClinicalTrials.gov identifier (NCT number): NCT01796782


Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: zhen Chen, M.D. Fudan University
Study Director: lu ming Liu, M.D. Fudan University

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Responsible Party: liu lu ming, professor, Fudan University
ClinicalTrials.gov Identifier: NCT01796782     History of Changes
Other Study ID Numbers: TCM-002
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents