A Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer

  • STATUS
    Recruiting
  • End date
    Dec 21, 2021
  • participants needed
    1880
  • sponsor
    National Cancer Center, Korea
Updated on 21 January 2021
ct scan
gastrectomy
cancer
metastasis
gastric cancer
adenocarcinoma

Summary

In oncological aspect, D1+ lymph node dissection would be enough for early stage gastric cancer in advanced gastric cancer (stage IB/IIA/IIB ).

Description

Background of Hypothesis A. JCOG (Japanese Clinical Oncology Group) 9501 Study

: Addition of aorta lymph node dissection to D2 lymph node dissection does not increase survival rate.

Wide range of operation is not always the best treatment. If invasion rate can be kept as minimal as possible while maintaining survival rate, it can lead to more secure operation while also reducing the frequency of complication after the surgery. 20 It may be advantageous for patients in terms of operation time, cost, and quality of life.

B. COACT 1001 study A previous study which compared the feasibility of lymph node dissection in open surgery and lapraroscopic surgery for advanced gastric cancer.

11p, 12a lymph node (D2) resection rate: 79.2% and 88.8% respectively in all advance gastric cancer.

11p, 12a lymph node (D2) metastasis rate: 1.9% and 2.9% respectively. Subgroup analysis 11p, 12a lymph node resection in cStage IB/IIA: 74.5-80.0% and 86.7-96.1% respectively. : 0% metastasis rate for both.

lymph node dissection in cStage IIB/IIIA: 81.1-82.3% and 87.5-89.2% respectively.: metastasis rates are 2.1% and 2.4-12.1% respectively.

Application: 11p and 12a lymph nodes, which belong in D2 lymph nodes, need to be resected in advance gastric cancer in IIB stage or higher. However, in earlier stages of advance gastric cancer, the probability of metastasis is very low; therefore, resection of D1+ lymph nodes, excluding 11p and 12a, is enough.

Details
Condition Gastric Adenocarcinoma, stomach adenocarcinoma
Treatment D2 distal subtotal gastrectomy, D1+ distal subtotal gastrectomy
Clinical Study IdentifierNCT02144727
SponsorNational Cancer Center, Korea
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically proven primary gastric adenocarcinoma
T1N1, T2N0, T2N1, T3N0, T3N1 by CT scan (AJCC 7th classification) and intraoperative surgical staging prior to resectional procedure
Location of primary tumor; antrum, or angle, lower body or mid body of the stomach
No evidence of other distant metastasis
Aged 20 year old
Performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
No prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection
Adequate organ functions defined as indicated below
WBC 3000/mm3 - 12,000/mm3
>serum Hemoglobin 8.0 g/dl
> serum Platelet 100 000/mm3
< serum AST 100 IU/l
<serum ALT 100 IU/l
< Total Bilirubin 2.0 mg/dl
Written signed informed consent

Exclusion Criteria

Active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)
Gastric remnant cancer
T4a in surgical staging before resection
N2 or more (number of metastatic lymph nodes 3) in CT scan
Histologically rare variants in WHO Classification such as Adenosquamous, Hepatoid, Squamous cell, Undifferentiated, , neuroendocrine carcinoma and others
Pregnant or breast-feeding women
Mental disorder(diagnosed with mental disorder on medical record)
systemic administration of corticosteroids(include Herbal Medication)
unstable angina or myocardial infarction within 6 months of the trial
unstable hypertension
severe respiratory disease requiring continuous oxygen therapy
previous upper abdominal surgery except laparoscopic cholecystectomy
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