Stomach NeoplasmsNCT02298010
Lymph Node Metastasis in Extended Lymphadenectomy for Gastric Cancer From a CLASSIC Trial
An observational study of Stomach Neoplasms and Cancer of Lymph Node, run by Seoul National University Hospital.
Trial summary
The pattern of lymph node metastasis of the gastric cancer to each geographic lymph nose stations and the relation between each metastasis and survival are to be analyzed by retrospective review of medical records of who enrolled in the CLASSIC trial (NCT00411229) which have compared adjuvant chemotherapy and no… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms, Cancer of Lymph Node
- What is being tested?
- Capecitabine, oxaliplatin
- How many people
- 899 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study subjects who were enrolled in CLASSIC trial (NCT00411229) and whose medical records about the extent of the lymph node dissection and pathologic report are available.
Who may be able to join
- To be eligible for inclusion, each patient must fulfill each of the following criteria:
- Ambulatory males or females, aged ≥18 years.
- Karnofsky performance status of ≥70 %.
- Histologically confirmed gastric adenocarcinoma, staged pathologically, AJCC/UICC stage II (T2N1, T1N2, T3N0), IIIa (T3N1, T2N2, T4N0), and IIIb (T3N2). At least 15 examined lymph nodes are required to ensure the adequate TNM classification)
- Patients who underwent curative D2 lymphadenectomy resection for gastric cancer with no macroscopic or microscopic evidence for remaining tumor, who can be randomized to either study arm within 6 weeks after surgery.
- Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Who cannot join
- Patients who fulfill any of the following criteria will be excluded:
- Serious concomitant medical illnesses that would limit life expectancy to < 5 years.
- Pregnant or lactating women.
- Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child bearing potential.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Any evidence of metastatic disease (including presence of tumor cells in the ascites).
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- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
- History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
- Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
- Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
- Known peripheral neuropathy ≥ CTCAEv3 grade 1. Absence of deep tendon reflexes (DTRs) as the sole neurologic abnormality does not render the patient ineligible.
- Organ allografts requiring immunosuppressive therapy.
- Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.-
- Moderate or severe renal impairment [creatinine clearance equal to or below 50 ml/min (calculated according to Cockroft and Gault)], or serum creatinine > 1.5 x upper limit of normal (ULN).
- Any of the following laboratory values:
- Absolute neutrophil count (ANC) < 1.5 x 10^9/L
- Platelet count < 100 x 10^9/L
- Total bilirubin > 1.5 x ULN
- ALAT, ASAT > 2.5 x ULN
- Alkaline phosphatase > 2.5 x ULN.
- Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) or patients with Kknown dihydropyrimidine dehydrogenase (DPD) deficiency.
- Hypersensitivity to platinum compounds or any of the components of the study medications.
- Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization.
- Blood transfusions or growth factors to aid hematologic recovery within 2 weeks prior to study treatment start.
- Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.
- Unwilling or unable to comply with the protocol for the duration of the study.
About this study
Official title: Pattern and Clinical Implication of Lymph Node Metastasis From Gastric Cancer Which Was Resected by Radical Surgery With Extended Lymphadenectomy
The pattern of lymph node metastasis of the gastric cancer to each geographic lymph nose stations and the relation between each metastasis and survival are to be analyzed by retrospective review of medical records of who enrolled in the CLASSIC trial (NCT00411229) which have compared adjuvant chemotherapy and no adjuvant therapy after radical gastrectomy with extended lymphadenectomy.
- Conditions
- Stomach Neoplasms, Cancer of Lymph Node
- Being tested
- Capecitabine, oxaliplatin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine, oxaliplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant chemotherapy group | Research subjects who were enrolled in CLASSIC trial and underwent adjuvant chemotherapy. Receives: Drug: Capecitabine, oxaliplatin | |
| Only surgery group | Research subjects who were enrolled in CLASSIC trial and did not undergo adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Topographic pattern of metastasis to regional lymph node stations
Measured: at the time of surgery
Secondary outcomes (3)
survival according to the metastatic lymph node station
Measured: 3 and 5years
survival according to lymph node ratio
Measured: 3 and 5years
recurrence pattern
Measured: 3 and 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 899 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Vincent's Hospital, Korea, Gachon University Gil Medical Center, Gangnam Severance Hospital, Kyungpook National University Hospital, Kyunghee University Medical Center, Keimyung University Dongsan Medical Center, Korea University Guro Hospital, Korea University Anam Hospital, Kosin University Gospel Hospital, National Cancer Center, Korea, Seoul Veterans Hospital, Seoul National University Bundang Hospital, Soonchunhyang University Hospital, Severance Hospital, Ajou University, Yeungnam University Hospital, Korea Cancer Center Hospital, Ewha Womans University Mokdong Hospital, Chonbuk National University Hospital, Chonnam National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298010
- Sponsor's protocol ID
- ML29471
- Status last verified
- Nov 2017
- First submitted
- 19 Nov 2014
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern and Clinical Implication of Lymph Node Metastasis From Gastric Cancer Which Was Resected by Radical Surgery With Extended Lymphadenectomy
- ClinicalTrials.gov ID
- NCT02298010
- Acronym / sponsor ID
- ML29471
- Conditions
- Stomach Neoplasms, Cancer of Lymph Node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 899 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Saint Vincent's Hospital, Korea, Gachon University Gil Medical Center, Gangnam Severance Hospital, Kyungpook National University Hospital, Kyunghee University Medical Center, Keimyung University Dongsan Medical Center, Korea University Guro Hospital, Korea University Anam Hospital, Kosin University Gospel Hospital, National Cancer Center, Korea, Seoul Veterans Hospital, Seoul National University Bundang Hospital, Soonchunhyang University Hospital, Severance Hospital, Ajou University, Yeungnam University Hospital, Korea Cancer Center Hospital, Ewha Womans University Mokdong Hospital, Chonbuk National University Hospital, Chonnam National University Hospital
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Nov 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.
The pattern of lymph node metastasis of the gastric cancer to each geographic lymph nose stations and the relation between each metastasis and survival are to be analyzed by retrospective review of medical records of who enrolled in the CLASSIC trial (NCT00411229) which have compared adjuvant chemotherapy and no adjuvant therapy after radical gastrectomy with extended lymphadenectomy.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant chemotherapy group | – | Drug: Capecitabine, oxaliplatinResearch subjects who were enrolled in CLASSIC trial and underwent adjuvant chemotherapy. |
| Only surgery group | – | –Research subjects who were enrolled in CLASSIC trial and did not undergo adjuvant chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects who were enrolled in CLASSIC trial (NCT00411229) and whose medical records about the extent of the lymph node dissection and pathologic report are available.
Key inclusion criteria (6 listed)
- Ambulatory males or females, aged ≥18 years.
- Karnofsky performance status of ≥70 %.
- Histologically confirmed gastric adenocarcinoma, staged pathologically, AJCC/UICC stage II (T2N1, T1N2, T3N0), IIIa (T3N1, T2N2, T4N0), and IIIb (T3N2). At least 15 examined lymph nodes are required to ensure the adequate TNM classification)
- Patients who underwent curative D2 lymphadenectomy resection for gastric cancer with no macroscopic or microscopic evidence for remaining tumor, who can be randomized to either study arm within 6 weeks after surgery.
- Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Key exclusion criteria (27 listed)
- Serious concomitant medical illnesses that would limit life expectancy to < 5 years.
- Pregnant or lactating women.
- Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child bearing potential.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Any evidence of metastatic disease (including presence of tumor cells in the ascites).
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 |
|---|---|---|
| Capecitabine, oxaliplatin | Drug | Adjuvant chemotherapy group |
Primary outcome
Topographic pattern of metastasis to regional lymph node stations
Time frame: at the time of surgery
3 secondary outcomes
survival according to the metastatic lymph node station
Time frame: 3 and 5years
survival according to lymph node ratio
Time frame: 3 and 5years
recurrence pattern
Time frame: 3 and 5years
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 14 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms and Cancer of Lymph Node, run by Seoul National University Hospital.
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 6 inclusion and 27 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 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Topographic pattern of metastasis to regional lymph node stations (time frame: at the time of surgery). 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 14 May 2019.