Advanced Gastric CancerPhase 3NCT02123407
Clinical Study on the Harvesting Lymph Nodes With Carbon Nanoparticles for Advanced Gastric Cancer
A Phase 3 study testing Carbon Nanoparticles and Gastrectomy with D2 dissection in people with Advanced Gastric Cancer, run by Peking University at 1 site in China.
Trial summary
Carbon Nanoparticles (CNP),with a mean size of 150 nm,can be taken up selectively by lymphatics after injection into the tissue and draining regional lymph nodes are thereby colored black,which may provide surgeons the guidance to lymph node dissection and help them harvest lymph nodes after surgery,especially some… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- Carbon Nanoparticles and Gastrectomy with D2 dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Jun 2014
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and CT confirmed resectable advanced gastric cancer
- No prior treatment
- No metastases
Who cannot join
- Having allergic reaction
- Pregnant
- R0 resection is not achieved by gastrectomy with D2 lymphadenectomy according to Japanese gastric cancer treatment guidelines 2010 (ver. 3)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University School of Oncology
Beijing, Beijing Municipality, 100142
Jiafu Ji, master, 86-10-88196048, dr.jijiafu@gmail.com
Jiafu Ji, master
About this study
Official title: Clinical Study on the Harvesting Lymph Nodes With Carbon Nanoparticles for Advanced Gastric Cancer：a Prospective Randomized Study
Carbon Nanoparticles (CNP),with a mean size of 150 nm,can be taken up selectively by lymphatics after injection into the tissue and draining regional lymph nodes are thereby colored black,which may provide surgeons the guidance to lymph node dissection and help them harvest lymph nodes after surgery,especially some small ones. but there was insufficient evidence to justify its efficacy for those purposes.Therefore,the investigators carried out a prospective randomized controlled trial on lymph node vital staining for lymph node dissection and harvesting in advanced gastric cancer to test this idea.
Read the detailed description
Carbon Nanoparticles (CNP),with a mean size of 150 nm,can be taken up selectively by lymphatics after injection into the tissue and draining regional lymph nodes are thereby colored black,which may provide surgeons the guidance to lymph node dissection and help them harvest lymph nodes after surgery,especially some small ones. but there was insufficient evidence to justify its efficacy for those purposes.Therefore,the investigators carried out a prospective randomized controlled trial on lymph node vital staining for lymph node dissection and harvesting in advanced gastric cancer to test this idea.
- Conditions
- Advanced Gastric Cancer
- Being tested
- Carbon Nanoparticles, Gastrectomy with D2 dissection
- Keywords
- Advanced Gastric Cancer, Carbon Nanoparticles, Lymph Nodes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon NanoparticlesDrug
Carbon Nanoparticles will be injected into the subserosa of stomach around the tumor.Gastrectomy with D2 dissection will be performed after the injection.
Gastrectomy with D2 dissectionProcedure or surgery
In the control arm,Gastrectomy with D2 dissection will be performed directly,without any coloring materials.
| Study group | Role | What they receive |
|---|---|---|
| Carbon Nanoparticles | Experimental | Carbon Nanoparticles could be used in this arm.The drug is injected into the subserosa of stomach.Injections of 1.0 ml of Carbon Nanoparticles (0.2 ml in each cardinal point adjacent to the lesion) will be performed about 10 minutes before surgery.Then,gastrectomy with D2 dissection will be performed. Receives: Drug: Carbon Nanoparticles |
| Gastrectomy with D2 dissection | Active comparator | Gastrectomy with D2 dissection will be performed in the control arm,no Carbon Nanoparticles or other coloring materials used Receives: Procedure: Gastrectomy with D2 dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of harvested lymph nodes
Measured: 1 day after operation
Secondary outcomes (1)
the diameter of harvested lymph nodes
Measured: 1 day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziyu Li, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123407
- Sponsor's protocol ID
- CA2014001
- Status last verified
- Apr 2014
- First submitted
- 21 Apr 2014
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62. doi: 10.1056/NEJMoa0707035.
PubMed 18669424Catarci M, Guadagni S, Zaraca F, Pistoia MA, Mastracchio A, Trecca A, Ruco L, Carboni M. Prospective randomized evaluation of preoperative endoscopic vital staining using CH-40 for lymph node dissection in gastric cancer. Ann Surg Oncol. 1998 Oct-Nov;5(7):580-4. doi: 10.1007/BF02303825.
PubMed 9831104Okamoto K, Sawai K, Minato H, Yada H, Shirasu M, Sakakura C, Otsuji E, Kitamura K, Taniguchi H, Hagiwara A, Yamaguchi T, Takahashi T. Number and anatomical extent of lymph node metastases in gastric cancer: analysis using intra-lymph node injection of activated carbon particles (CH40). Jpn J Clin Oncol. 1999 Feb;29(2):74-7. doi: 10.1093/jjco/29.2.74.
PubMed 10089947Siewert JR, Kestlmeier R, Busch R, Bottcher K, Roder JD, Muller J, Fellbaum C, Hofler H. Benefits of D2 lymph node dissection for patients with gastric cancer and pN0 and pN1 lymph node metastases. Br J Surg. 1996 Aug;83(8):1144-7. doi: 10.1002/bjs.1800830836.
PubMed 8869330
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
- Clinical Study on the Harvesting Lymph Nodes With Carbon Nanoparticles for Advanced Gastric Cancer：a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02123407
- Acronym / sponsor ID
- CA2014001
- Conditions
- Advanced Gastric Cancer
- Keywords
- Advanced Gastric Cancer, Carbon Nanoparticles, Lymph Nodes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (estimated)
- First posted
- 25 Apr 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.
Carbon Nanoparticles (CNP),with a mean size of 150 nm,can be taken up selectively by lymphatics after injection into the tissue and draining regional lymph nodes are thereby colored black,which may provide surgeons the guidance to lymph node dissection and help them harvest lymph nodes after surgery,especially some small ones. but there was insufficient evidence to justify its efficacy for those purposes.Therefore,the investigators carried out a prospective randomized controlled trial on lymph node vital staining for lymph node dissection and harvesting in advanced gastric cancer to test this idea.
Detailed description
Carbon Nanoparticles (CNP),with a mean size of 150 nm,can be taken up selectively by lymphatics after injection into the tissue and draining regional lymph nodes are thereby colored black,which may provide surgeons the guidance to lymph node dissection and help them harvest lymph nodes after surgery,especially some small ones. but there was insufficient evidence to justify its efficacy for those purposes.Therefore,the investigators carried out a prospective randomized controlled trial on lymph node vital staining for lymph node dissection and harvesting in advanced gastric cancer to test this idea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbon Nanoparticles | Experimental | Drug: Carbon NanoparticlesCarbon Nanoparticles could be used in this arm.The drug is injected into the subserosa of stomach.Injections of 1.0 ml of Carbon Nanoparticles (0.2 ml in each cardinal point adjacent to the lesion) will be performed about 10 minutes before surgery.Then,gastrectomy with D2 dissection will be performed. |
| Gastrectomy with D2 dissection | Active comparator | Procedure: Gastrectomy with D2 dissectionGastrectomy with D2 dissection will be performed in the control arm,no Carbon Nanoparticles or other coloring materials used |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically and CT confirmed resectable advanced gastric cancer
- No prior treatment
- No metastases
Key exclusion criteria (3 listed)
- Having allergic reaction
- Pregnant
- R0 resection is not achieved by gastrectomy with D2 lymphadenectomy according to Japanese gastric cancer treatment guidelines 2010 (ver. 3)
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 |
|---|---|---|
| Carbon NanoparticlesCarbon Nanoparticles will be injected into the subserosa of stomach around the tumor.Gastrectomy with D2 dissection will be performed after the injection. | Drug | Carbon Nanoparticles |
| Gastrectomy with D2 dissectionIn the control arm,Gastrectomy with D2 dissection will be performed directly,without any coloring materials. | Procedure or surgery | Gastrectomy with D2 dissection |
Primary outcome
the number of harvested lymph nodes
Time frame: 1 day after operation
1 secondary outcome
the diameter of harvested lymph nodes
Time frame: 1 day after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
- Background: PubMed 18669424Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62. doi: 10.1056/NEJMoa0707035.
- Background: PubMed 9831104Catarci M, Guadagni S, Zaraca F, Pistoia MA, Mastracchio A, Trecca A, Ruco L, Carboni M. Prospective randomized evaluation of preoperative endoscopic vital staining using CH-40 for lymph node dissection in gastric cancer. Ann Surg Oncol. 1998 Oct-Nov;5(7):580-4. doi: 10.1007/BF02303825.
- Background: PubMed 10089947Okamoto K, Sawai K, Minato H, Yada H, Shirasu M, Sakakura C, Otsuji E, Kitamura K, Taniguchi H, Hagiwara A, Yamaguchi T, Takahashi T. Number and anatomical extent of lymph node metastases in gastric cancer: analysis using intra-lymph node injection of activated carbon particles (CH40). Jpn J Clin Oncol. 1999 Feb;29(2):74-7. doi: 10.1093/jjco/29.2.74.
- Background: PubMed 8869330Siewert JR, Kestlmeier R, Busch R, Bottcher K, Roder JD, Muller J, Fellbaum C, Hofler H. Benefits of D2 lymph node dissection for patients with gastric cancer and pN0 and pN1 lymph node metastases. Br J Surg. 1996 Aug;83(8):1144-7. doi: 10.1002/bjs.1800830836.
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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.
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 Carbon Nanoparticles and Gastrectomy with D2 dissection in people with Advanced Gastric Cancer, run by Peking University 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 3 inclusion and 3 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: status not confirmed, 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiafu Ji, master (86-10-88196048, dr.jijiafu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of harvested lymph nodes (time frame: 1 day after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123407, which also lists 4 linked publications.
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.