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

Phase 3

• Conditions: Gastric Adenocarcinoma

• Registration Number: NCT02144727
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-22
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1880

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
overall survival	5 year	To test non-inferiority of survival of D1+ gastrectomy versus D2 gastrectomy for clinical stage I B \& II advanced gastric cancer

Secondary Outcome Measures

Name	Time	Method
Long term postoperative complications	after 30 days	Long term postoperative complications
Operating time	op day	Operating time
Overall cost for the treatment	operation day to discharge	Overall cost for the treatment (from operative day to discharge day)
Subgroup analysis of Laparoscopic surgery versus open surgery	3 year , 5 year	Subgroup analysis of Laparoscopic surgery versus open surgery in terms of 3 year relapse free survival and 5 year overall survival
Early postoperative complications	within 30 days	Early postoperative complications
Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)	baseline, 1 week, 1month, 6 month, 1 year, 3 year	Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)
Finding biomarkers predicting lymph node metastasis and recurrence	3 year	Finding biomarkers predicting lymph node metastasis and recurrence for prediction of lymph node metastasis and recurrence
disease free survival	3 year	3 year disease free survival

Trial Locations

Locations (50)

Soon Chun Hyang University Hospital Cheonan; 🇰🇷 Cheonan, Chuncheongnam-Do, Korea, Republic of

Konyang University Hospital; 🇰🇷 Metropolitan City Daejon, Daejon, Korea, Republic of

Kangwon National University Hospital; 🇰🇷 Chuncheon, Gangwon-Do, Korea, Republic of

Dongguk University Gyeongju Hospital; 🇰🇷 Gyeongju, Gyeongbuk, Korea, Republic of

Korea University Ansan Hospital; 🇰🇷 Ansan, Gyeonggi-Do, Korea, Republic of

Dongguk University Medical Center; 🇰🇷 Goyang, Gyeonggi-Do, Korea, Republic of

Hanyang University Guri Hospital; 🇰🇷 Guri, Gyeonggi-do, Korea, Republic of

The Catholic University of Korea St. Vincent's Hospital; 🇰🇷 Suwon, Gyeonggi-Do, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Gyeonggi-Do, Korea, Republic of

Gyengsang National University Hospital; 🇰🇷 Jinjoo, Gyeongsangnam-Do, Korea, Republic of

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