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

National Cancer Center (NCC)

Status and phase: Unknown; Phase 3

Conditions: Gastric Adenocarcinoma

Treatments: Procedure: D2 distal subtotal gastrectomy; Procedure: D1+ distal subtotal gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02144727

NCCCTS-13-712

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,880 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,880 participants in 2 patient groups

D2 distal subtotal gastrectomy

Active Comparator group

Description:

D2 distal subtotal gastrectomy D2 includes Nos.1.3,4sb,4d,5,6,7,8a,9,11p,and 12a nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy

Treatment:

Procedure: D2 distal subtotal gastrectomy

D1+ distal subtotal gastrectomy

Experimental group

Description:

D1+ distal subtotal gastrectomy D1+ includes Nos.1,3,4sb,4d,5,6,7,8a,and 9 nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy

Treatment:

Procedure: D1+ distal subtotal gastrectomy