Clinical trial NCT02572050: Assessment of a Robotic Distal Gastrectomy on Non-inferiority of N2 Area Nodal Dissection
Official title: Assessment of a Robotic Distal Gastrectomy on Non-inferiority of N2 Area Nodal Dissection for Clinical Stage II or III Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Keimyung University Dongsan Medical Center
name: Seoul National University Hospital
name: Seoul National University Bundang Hospital
name: Samsung Medical Center
name: Severance Hospital
name: Ajou University School of Medicine
name: Korea University
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
First posted: 2015-10-08
Enrollment: 87
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Designed as a single arm multi-center prospective phase II trial, which evaluates the number of dissected lymph nodes in the N2-area as a surrogate parameter for adequate D2 lymphadenectomy in robotic distal gastrectomy (RDG) for clinical stage II or III gastric cancer.

Detailed description: The number of retrieved LNs in the N2 area after RDG is going to be calculated according to the pathology reports and comparative analysis to a historic group undergone open surgery for clinical stage II or III gastric cancer at the NCC Korea last year.

METHODS AGAINST BIAS Minimizing selection bias: After initiation of the study, all patients will be screened consecutively and all eligible patients will be asked to enrol in the trial. The trial is designed as a prospective multi-center phase II trial. Patients are going to be allocated to RAG after giving signed consent after sufficient consideration time.

Minimizing performance bias: The study is planned as a prospective single arm multi-center trial, as the retrospective data suggest that there is no disadvantage in lymph node retrieval after RAG compared to LAG. Surgery is going to be performed according to the guidelines of the Japanese Research Society for the Study of Gastric Cancer (3rd edition). Japanese randomized controlled trials have proven effectiveness of adequate D2 lymphadenectomy in several randomized controlled trials. As number of dissected lymph nodes is a surrogate marker for adequate lymph node dissection, only patients with at least 25 lymph nodes removed (as obtained from pathology report) will be definitively included in the data assessment. Further lymph node stations No. #7, #8a, #9, #11p, #12a for subtotal gastrectomy according to the Japanese Guideline have to be dissected out of the surgical specimen and analyzed separately in the pathologic workup. All patients in the trial are going to be analyzed, as success rate of LN dissection in the N2-area is the primary endpoint. Surgery in the trial must be performed by a board certified surgeon who has taken part in a trial specific training course. Potential learning curve artefacts are negligible because the RAG is going to be performed by surgeons who are highly trained and experienced in robotic gastrectomy.

Participating surgeons should have experience as an operator of over 50 cases of open gastrectomy, over 50 laparoscopic gastrectomy, and over 15 cases of robotic gastrectomy. Furthermore, surgical quality will have to be enforced by intraoperative video documentation. Also, pictures of nodal dissection area after resection should be submitted to have a quality assurance.

Minimizing detection bias: Patients are going to regularly undergo standardized follow-up visits at 6, 12, 18, 24, 30, 36, 48, 60 months to be evaluated disease status with abdominopelvic CT. EGD will be done on 3, 12, 24, 36, 48 and 60 months.

Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma of the stomach in patients that have not received any previous treatment for their cancer
* Tumours should be stage II or III according to the UICC 7th edition with no sign of distant metastasis and deemed resectable (R0) by the operating surgeon on preoperative staging by EGD, and CT of abdomen and pelvis
* Location of the tumor at the pylorus, antrum, angle, lower body and midbody to allow subtotal gastrectomy
* Age ≥ 19 years
* Written informed consent

Exclusion Criteria:

* Performance status ≥3
* Patients not eligible for surgery (ASA \>=4)
* History of another primary cancer, except curatively treated in situ cervical cancer, curatively resected non-melanoma skin cancer. The inclusion of patients with other types of cancer that were successfully treated and did not recur within the last 5 years prior to study enrolment have to be discussed with the principal investigator.
* Evidence of distant metastasis on clinical staging
* Primary tumour deemed unresectable by operating surgeon
* Inadequate organ function as below

  * Bone marrow function defined as: (ANC ≤1.0x109/l, WBC (total) ≤ 2.5x109/l, Platelet Count ≤ 70x109/l, Haemoglobin ≤ 8 g/dl (can be post-transfusion)

    * Renal function with serum Creatinine ≥1.5 mg/dL) ③ Liver function defined as (Total Bilirubin≥ 2.0x (ULN), ALT/AST ≥2.5x ULN) ④ Coagulation profile: with PT (INR) ≥1.5, aPTT(sec) ≥1.5xULN
* Women of childbearing potential should have a negative pregnancy test within 7 days prior to commencing treatment, and must take adequate contraceptive precautions
* Simultaneous participation in another clinical trial.

Primary outcomes:
measure: Number of retrieved lymph nodes in the topographical N2 area
timeFrame: 1 week
Secondary outcomes:
measure: Overall-survival
timeFrame: five years
measure: Recurrence-free survival
timeFrame: Three Year
measure: Incidence of local recurrence
timeFrame: Five Year
measure: Early Complications
timeFrame: 1 month
measure: Late Complications
timeFrame: 5 year
measure: Quality of life
timeFrame: 5 year
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center of Korea
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Aju University Hospital
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center of Korea
name: Young-Woo Kim, PhD
role: PRINCIPAL_INVESTIGATOR
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