Locally Advanced Gastric CarcinomaPhase 1/2NCT02048540
Neoadjuvant Bev Plus DOF vs DOF in LAGC and Its Association With Circulating Tumor Cell
A Phase 1/2 study testing Bevacizumab, docetaxel oxaliplatin 5-FU CF and Gastrectomy in people with Locally Advanced Gastric Carcinoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Background Local advanced gastric carcinoma (LAGC) is suggested to be potentially cured by R0 resection, and neoadjuvant chemotherapy can increase the R0 resection rate but not enough. Bevacizumab (Bev), an anti-tumor angiogenesis monoclonal antibody, combined with chemotherapy has been shown effective in advanced GC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Gastric Carcinoma
- What is being tested?
- Bevacizumab, docetaxel oxaliplatin 5-FU CF and Gastrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- Feb 2009to Dec 2013
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed locally advanced adenocarcinoma of the stomach.
- Age of 18 to 70, Karnofsky score higher than 80.
- T3-4，N1-3，M0 (AJCC 7th), potentially resectable.
- No severe functional damage of major organ, normal blood cell, normal liver and kidney function.
Who cannot join
- Clinical findings of distant metastasis or Peritoneal carcinomatosis
- Prior systemic (chemo- or targeted) treatment. Prior radiotherapy to the upper abdomen
- Previous malignancy within 5 years, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
- Upper gastrointestinal bleeding
- Any contraindication to treatment with docetaxel, 5-fu or oxaliplatin
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100048
About this study
Official title: Phase 2 Study of Neoadjuvant Bevacizumab Plus DOF Versus DOF in Local Advanced Gastric Carcinoma and Its Association With Circulating Tumor Cell
Background Local advanced gastric carcinoma (LAGC) is suggested to be potentially cured by R0 resection, and neoadjuvant chemotherapy can increase the R0 resection rate but not enough. Bevacizumab (Bev), an anti-tumor angiogenesis monoclonal antibody, combined with chemotherapy has been shown effective in advanced GC. In addition, CTC has been suggested as an indicator of the anti-tumor drugs' efficacy. Therefore, in this study, the investigators plan to evaluate the efficacy and safety of neoadjuvant Bev plus docetaxel/oxaliplatin/5-FU/CF (DOF) versus DOF in mainly gastric antrum LAGC, and to investigate whether CTC is an effectiveness indicator.
Methods 86 patients diagnosed as IIIb-IIIc GC have been enrolled and randomly assigned (1:1) to receive neoadjuvant Bev (5 mg/kg, d1) plus DOF (docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2) or DOF each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles. The primary endpoint is R0 resection rate. CTC was detected every 8 weeks. All patients signed the informed consent.
- Conditions
- Locally Advanced Gastric Carcinoma
- Being tested
- Bevacizumab, docetaxel oxaliplatin 5-FU CF, Gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabBiological
Bev (5 mg/kg, d1) every 3 weeks, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles.
docetaxel oxaliplatin 5-FU CFDrug
docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2 each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles.
GastrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab plus DOF | Experimental | patients receive bev +DOF pre and post surgery up to total 6 cycles Receives: Biological: Bevacizumab; Drug: docetaxel oxaliplatin 5-FU CF; Procedure: Gastrectomy |
| DOF | Active comparator | patients receive DOF pre and post surgery up to total 6 cycles Receives: Drug: docetaxel oxaliplatin 5-FU CF; Procedure: Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Measured: 6-12 weeks after administration
Secondary outcomes (5)
pCR rate
Measured: Day 1 after surgery
OS
Measured: 3 years after surgery
DFS
Measured: 3 years after surgery
ORR
Measured: 6 weeks after administration
safety of peroperative treatment and surgery
Measured: from first administration to 28 days after last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startFeb 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 Locally Advanced Gastric CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DuNan, Chinese PLA General Hospital
- Investigators
- Nan Du, Phd, Principal investigator, First Affiliated Hospital, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048540
- Sponsor's protocol ID
- GC neoadjuvant bev CTC
- Other IDs
- BSC2013-dunan
- Status last verified
- Apr 2014
- First submitted
- 25 Jan 2014
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Neoadjuvant Bevacizumab Plus DOF Versus DOF in Local Advanced Gastric Carcinoma and Its Association With Circulating Tumor Cell
- ClinicalTrials.gov ID
- NCT02048540
- Acronym / sponsor ID
- GC neoadjuvant bev CTC
- Conditions
- Locally Advanced Gastric Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jan 2014 (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.
Background Local advanced gastric carcinoma (LAGC) is suggested to be potentially cured by R0 resection, and neoadjuvant chemotherapy can increase the R0 resection rate but not enough. Bevacizumab (Bev), an anti-tumor angiogenesis monoclonal antibody, combined with chemotherapy has been shown effective in advanced GC. In addition, CTC has been suggested as an indicator of the anti-tumor drugs' efficacy. Therefore, in this study, the investigators plan to evaluate the efficacy and safety of neoadjuvant Bev plus docetaxel/oxaliplatin/5-FU/CF (DOF) versus DOF in mainly gastric antrum LAGC, and to investigate whether CTC is an effectiveness indicator.
Methods 86 patients diagnosed as IIIb-IIIc GC have been enrolled and randomly assigned (1:1) to receive neoadjuvant Bev (5 mg/kg, d1) plus DOF (docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2) or DOF each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles. The primary endpoint is R0 resection rate. CTC was detected every 8 weeks. All patients signed the informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevacizumab plus DOF | Experimental | Biological: Bevacizumab, Drug: docetaxel oxaliplatin 5-FU CF, Procedure: Gastrectomypatients receive bev +DOF pre and post surgery up to total 6 cycles |
| DOF | Active comparator | Drug: docetaxel oxaliplatin 5-FU CF, Procedure: Gastrectomypatients receive DOF pre and post surgery up to total 6 cycles |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed locally advanced adenocarcinoma of the stomach.
- Age of 18 to 70, Karnofsky score higher than 80.
- T3-4，N1-3，M0 (AJCC 7th), potentially resectable.
- No severe functional damage of major organ, normal blood cell, normal liver and kidney function.
Key exclusion criteria (5 listed)
- Clinical findings of distant metastasis or Peritoneal carcinomatosis
- Prior systemic (chemo- or targeted) treatment. Prior radiotherapy to the upper abdomen
- Previous malignancy within 5 years, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
- Upper gastrointestinal bleeding
- Any contraindication to treatment with docetaxel, 5-fu or oxaliplatin
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 |
|---|---|---|
| BevacizumabBev (5 mg/kg, d1) every 3 weeks, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles. | Biological | bevacizumab plus DOF |
| docetaxel oxaliplatin 5-FU CFdocetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2 each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles. | Drug | DOF, bevacizumab plus DOF |
| Gastrectomy | Procedure or surgery | DOF, bevacizumab plus DOF |
Primary outcome
R0 resection rate
Time frame: 6-12 weeks after administration
5 secondary outcomes
pCR rate
Time frame: Day 1 after surgery
OS
Time frame: 3 years after surgery
DFS
Time frame: 3 years after surgery
ORR
Time frame: 6 weeks after administration
safety of peroperative treatment and surgery
Time frame: from first administration to 28 days after last administration
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 25 Apr 2014.
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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.
Nan Du, Phd principal investigator
First Affiliated Hospital, Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bevacizumab, docetaxel oxaliplatin 5-FU CF and Gastrectomy in people with Locally Advanced Gastric Carcinoma, run by Chinese PLA General Hospital 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 4 inclusion and 5 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 25 Apr 2014. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
R0 resection rate (time frame: 6-12 weeks after administration). 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 25 Apr 2014.