Lymph Node Metastasis in Extended Lymphadenectomy for Gastric Cancer From a CLASSIC Trial

NCT02298010 | Completed

• 1 other identifier: ML29471
• Study Type: observational
• Target: 899
• Locations: 0 countries
• Sites: N/A

Brief 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 adjuvant therapy after radical gastrectomy with extended lymphadenectomy.

Conditions

Stomach Neoplasms; Cancer of Lymph Node

Outcome Measures

Primary Outcomes (1)

• Topographic pattern of metastasis to regional lymph node stations

  at the time of surgery

Secondary Outcomes (3)

• survival according to the metastatic lymph node station

  3 and 5years

• survival according to lymph node ratio

  3 and 5years

• recurrence pattern

  3 and 5years

Study Arms (2)

Adjuvant chemotherapy group

Research subjects who were enrolled in CLASSIC trial and underwent adjuvant chemotherapy.

Drug: Capecitabine, oxaliplatin

Only surgery group

Research subjects who were enrolled in CLASSIC trial and did not undergo adjuvant chemotherapy

Interventions

Capecitabine, oxaliplatin DRUG

Adjuvant chemotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Saint Vincent's Hospital, Korea: collaborator
• Gachon University Gil Medical Center: collaborator
• Gangnam Severance Hospital: collaborator
• Kyungpook National University Hospital: collaborator
• Kyunghee University Medical Center: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Korea University Guro Hospital: collaborator
• Korea University Anam Hospital: collaborator
• Kosin University Gospel Hospital: collaborator
• National Cancer Center, Korea: collaborator
• Seoul Veterans Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• Soonchunhyang University Hospital: collaborator
• Severance Hospital: collaborator
• Ajou University: collaborator
• Yeungnam University Hospital: collaborator
• Korea Cancer Center Hospital: collaborator
• Ewha Womans University Mokdong Hospital: collaborator
• Chonbuk National University Hospital: collaborator
• Chonnam National University Hospital: collaborator

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

XELOX

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 21, 2014
• Study Start: January 1, 2016
• Primary Completion: February 1, 2016
• Study Completion: December 1, 2017
• Last Updated: May 14, 2019

Record last verified: 2017-11