Gallbladder NeoplasmsPhase 3NCT01053390
New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
A Phase 3 study testing Somatostatin and epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil） in people with Gallbladder Neoplasms, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Objective Primary: Determine the objective response rate in patients with advanced gallbladder treated with new Chemotherapy regimen Secondary: Determine time to progression-free survival and overall survival of patients treated with this regimen. Determine quality of life of patients treated with this regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallbladder Neoplasms
- What is being tested?
- Somatostatin and epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- Oct 2009to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unresectable locally advanced disease or unresectable local recurrence, including:
- Patients with unresectable advanced gallbladder cancer （≥ Nevin staging IV or TNM（ tumor node metastasis） classification）
- Patients with complication who have no indication for surgery
- Patients with unresectable local recurrence lesions
- Age between 18-75, no gender-based constraints
- Estimated life expectancy ≥12 weeks
Show all 13Show fewer
- KPS（Karnofsky performance status ）≥60
- Each patient gave written informed consent
- < 2 previous chemotherapy regimes
- No chemotherapy done in the last 4 weeks
- Laboratory test criteria:Haemoglobin ≥ 10g/dl, white blood cell count > 3,000/mm3 ;Platelet >100,000/mm3 Total bilirubin <5.0mg/dl ALT（alanine transaminase）、 AST（aspartate aminotransferase)≤ 2.5 times upper limit of normal BUN（blood urea nitrogen）≤ 2 times upper limit of normal; serum creatinine <1.5mg/dl: creatinine clearance rate < 60 ml/min
- Patients are required to have histologically confirmed diagnosis via puncture based at least on computed tomography (CT) or ultrasound
- Jaundice should be reduced to standard level before chemotherapy (Total bilirubin <5.0 mg/dl)
Who cannot join
- Patients with extensive metastasis and generally poor condition who can not tolerate chemotherapy
- Patients who are pregnant or breastfeeding.
- Patients with other clinically significant laboratory abnormalities, uncontrolled infection, concurrent severe medical problems unrelated to malignancy
- Patients who had a history of previous carcinoma in the last 5 years.
- Patients who are allergic to somatostatin or fluorouracil
- Patients who refuse chemotherapy, or to sign the informed consent and chemotherapy consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Study of New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
Objective Primary:
Determine the objective response rate in patients with advanced gallbladder treated with new Chemotherapy regimen
Secondary:
Determine time to progression-free survival and overall survival of patients treated with this regimen.
Determine quality of life of patients treated with this regimen. Determine the toxicity of new chemotherapy regimen
Read the detailed description
Study Design: Treatment, Randomized, Open Label, controlled,Multicenter Group Assignment, Safety/Efficacy Study
Chemotherapy regimen:
Group A: Conventional chemotherapy regimen Group B: New chemotherapy regimen: conventional regimen plus SST（somatostatin） Cycles repeat every 4 weeks and 6 cycles in total
Patients: A total of 260 patients (130 per group) will be accrued for this study.
Patients distribution:
10patients per center are enrolled in the study and 30 centers (hospitals) in total which meet the total number of patients in trial.
Clinical Outcome Assessments:
Primary: the objective response rate (response evaluation criteria in solid tumors ,RECIST criteria) Secondary: progression-free survival, overall survival, quality of life，the adverse event
Safety Assessments:
Physical exam, laboratory test, probably occurred adverse event.
- Conditions
- Gallbladder Neoplasms
- Being tested
- Somatostatin, epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）
- Keywords
- gallbladder neoplasmas, Gallbladder Neoplasms,Advanced Stage,Chemotherapy,Somatostatin
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatostatinDrug
Somatostatin 3mg+NS（normal saline）60ml, a continuous intravenous infusion, q12h
epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）Drug
| Study group | Role | What they receive |
|---|---|---|
| epirubicin,cisplatin,LV（Leucovorin）、5-FU (5-Fluorouracil) | Active comparator | conventional regimen Receives: Drug: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil） |
| Somatotatin | Experimental | Conventional chemotherapy regimen plus somatostatin Receives: Drug: Somatostatin; Drug: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil） |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response)
Measured: 6 month after first treatment
Secondary outcomes (1)
A: KPS (karnofsky performance score) B:Laboratory tests: Reexamination of CA19-9（Carbohydrate Antigen 19-9）、 CEA（ carcinoembryonic antigen）, especially for those which are abnormal prior to chemotherapy
Measured: 6 month after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Capital Medical University, Peking University First Hospital, Tianjin Medical University Cancer Institute and Hospital, The First Affiliated Hospital of Dalian Medical University, China Medical University, China, The first clinical college of harbin medical university, The Second Affiliated Hospital of Harbin Medical University, Shengjing Hospital, Jilin University, The people's hospital of Heilongjiang province, Eastern Hepatobiliary Surgery Hospital, Shanghai Changzheng Hospital, Shandong Provincial Hospital, Qilu Hospital of Shandong University, Air Force Military Medical University, China, Tang-Du Hospital, Qinghai People's Hospital, Affiliated Hospital of Qinghai University, First Affiliated Hospital of Chongqing Medical University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First People's Hospital of Kunming, Lanzhou University Second Hospital, Xi'an Central Hospital, The First People's Hospital of Guiyang, Southwest Hospital, China, First Affiliated Hospital of Kunming Medical University
- Responsible party
- Principal investigator, Zhi-wei Quan, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhi-wei Quan, MD, Study chair, Xinhua hospital affiliated shanghai jiaotong university school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053390
- Sponsor's protocol ID
- xh2009-35
- Status last verified
- Dec 2013
- First submitted
- 20 Jan 2010
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
- ClinicalTrials.gov ID
- NCT01053390
- Acronym / sponsor ID
- xh2009-35
- Conditions
- Gallbladder Neoplasms
- Keywords
- gallbladder neoplasmas, Gallbladder Neoplasms,Advanced Stage,Chemotherapy,Somatostatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Capital Medical University, Peking University First Hospital, Tianjin Medical University Cancer Institute and Hospital, The First Affiliated Hospital of Dalian Medical University, China Medical University, China, The first clinical college of harbin medical university, The Second Affiliated Hospital of Harbin Medical University, Shengjing Hospital, Jilin University, The people's hospital of Heilongjiang province, Eastern Hepatobiliary Surgery Hospital, Shanghai Changzheng Hospital, Shandong Provincial Hospital, Qilu Hospital of Shandong University, Air Force Military Medical University, China, Tang-Du Hospital, Qinghai People's Hospital, Affiliated Hospital of Qinghai University, First Affiliated Hospital of Chongqing Medical University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First People's Hospital of Kunming, Lanzhou University Second Hospital, Xi'an Central Hospital, The First People's Hospital of Guiyang, Southwest Hospital, China, First Affiliated Hospital of Kunming Medical University
- Study start
- Oct 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective Primary:
Determine the objective response rate in patients with advanced gallbladder treated with new Chemotherapy regimen
Secondary:
Determine time to progression-free survival and overall survival of patients treated with this regimen.
Determine quality of life of patients treated with this regimen. Determine the toxicity of new chemotherapy regimen
Detailed description
Study Design: Treatment, Randomized, Open Label, controlled,Multicenter Group Assignment, Safety/Efficacy Study
Chemotherapy regimen:
Group A: Conventional chemotherapy regimen Group B: New chemotherapy regimen: conventional regimen plus SST（somatostatin） Cycles repeat every 4 weeks and 6 cycles in total
Patients: A total of 260 patients (130 per group) will be accrued for this study.
Patients distribution:
10patients per center are enrolled in the study and 30 centers (hospitals) in total which meet the total number of patients in trial.
Clinical Outcome Assessments:
Primary: the objective response rate (response evaluation criteria in solid tumors ,RECIST criteria) Secondary: progression-free survival, overall survival, quality of life，the adverse event
Safety Assessments:
Physical exam, laboratory test, probably occurred adverse event.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epirubicin,cisplatin,LV（Leucovorin）、5-FU (5-Fluorouracil) | Active comparator | Drug: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）conventional regimen |
| Somatotatin | Experimental | Drug: Somatostatin, Drug: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）Conventional chemotherapy regimen plus somatostatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with unresectable locally advanced disease or unresectable local recurrence, including:
- Age between 18-75, no gender-based constraints
- Estimated life expectancy ≥12 weeks
- KPS（Karnofsky performance status ）≥60
- Each patient gave written informed consent
Key exclusion criteria (6 listed)
- Patients with extensive metastasis and generally poor condition who can not tolerate chemotherapy
- Patients who are pregnant or breastfeeding.
- Patients with other clinically significant laboratory abnormalities, uncontrolled infection, concurrent severe medical problems unrelated to malignancy
- Patients who had a history of previous carcinoma in the last 5 years.
- Patients who are allergic to somatostatin or fluorouracil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomatostatinSomatostatin 3mg+NS（normal saline）60ml, a continuous intravenous infusion, q12h | Drug | Somatotatin |
| epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil） | Drug | Somatotatin, epirubicin,cisplatin,LV（Leucovorin）、5-FU (5-Fluorouracil) |
Primary outcome
(Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response)
Time frame: 6 month after first treatment
1 secondary outcome
A: KPS (karnofsky performance score) B:Laboratory tests: Reexamination of CA19-9（Carbohydrate Antigen 19-9）、 CEA（ carcinoembryonic antigen）, especially for those which are abnormal prior to chemotherapy
Time frame: 6 month after first treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi-wei Quan, MD study chair
Xinhua hospital affiliated shanghai jiaotong university school of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Somatostatin and epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil） in people with Gallbladder Neoplasms, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response) (time frame: 6 month after first treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2013.