Clinical trial NCT02144727: A Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer
Official title: A Multicenter Randomized Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Adenocarcinoma
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2014-05-22
Enrollment: 1880
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: 5 year
Secondary outcomes:
measure: disease free survival
timeFrame: 3 year
measure: Subgroup analysis of Laparoscopic surgery versus open surgery
timeFrame: 3 year , 5 year
measure: Operating time
timeFrame: op day
measure: Early postoperative complications
timeFrame: within 30 days
measure: Long term postoperative complications
timeFrame: after 30 days
measure: Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)
timeFrame: baseline, 1 week, 1month, 6 month, 1 year, 3 year
measure: Overall cost for the treatment
timeFrame: operation day to discharge
measure: Finding biomarkers predicting lymph node metastasis and recurrence
timeFrame: 3 year
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
state: Chuncheongnam-Do
city: Metropolitan City Daejon
country: Korea, Republic of
facility: Konyang University Hospital
state: Daejon
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
state: Gangwon-Do
city: Gyeongju
country: Korea, Republic of
facility: Dongguk University Gyeongju Hospital
state: Gyeongbuk
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-Do
city: Goyang
country: Korea, Republic of
facility: Dongguk University Medical Center
state: Gyeonggi-Do
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
state: Gyeonggi-Do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-Do
city: Jinjoo
country: Korea, Republic of
facility: Gyengsang National University Hospital
state: Gyeongsangnam-Do
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyunggi-Do
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
state: Jeju Special Self-Governing Province
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jellabuk-Do
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
state: Jellanam-Do
city: Hwasun-Gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jellanam-Do
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Dongnam Inst. Of Radiological & Medical Sciences
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Veterans Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic Univ. Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gill Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Red Cross Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Seoul
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
Study officials:
affiliation: National Cancer Center, Korea
name: Young Woo Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: