JCOG2013: A multicenter randomized controlled trial of esophagectomy with or without prophylactic supraclavicular node dissection: a phase 3 trial

JRCT ID: jRCT1030220248

Registered date:07/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 18/08/2022
• Target sample size: 480
• Study type: Interventional

Intervention(s)

A: Esophagectomy with prophylactic supraclavicular node (104) dissection (Control arm, D2 dissection)
B: Esophagectomy without prophylactic supraclavicular node (104) dissection (Intervention arm, D2-104 dissection)

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Relapse free survival, postoperative complications, delayed toxicity, incidence of supraclavicular node (104) recurrence, incidence of only supraclavicular node (104) recurrence, incidence of salvage cervical surgery / chemoradiotherapy / radiotherapy, proportion of synchronous cervical and abdominal procedure, operation time, and number of operating surgeons.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

(1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
(2) Primary tumor located in the upper thoracic or the mid-thoracic portion of the esophagus and all lesions located in the thoracic esophagus.
(3) Multiple tumors are eligible. Secondary lesion in the cervical esophagus which is indicated for endoscopic resection (EMR/ESD) is eligible.
(4) Clinical Stage I, II, III, or IVA (except for T4) based on the cervical to abdominal contrast-enhanced CT (UICC-TNM 8th edition). In case patients have undergone neoadjuvant chemotherapy (DCF based on JCOG1109 or CF based on JCOG9907), they are eligible if only pretreatment stages are I, II, III, or IVA (except for T4) and currently there is no evidence of T4 nor adjacent organ involvement from metastatic lymph nodes.
(5) Aged 18 to 80 years old.
(6) ECOG Performance status 0 or 1.
(7) Fit for one-stage right-thoracoabdominal esophagectomy including minimally invasive procedure (thoracoscopy, laparoscopy, and robot-assisted) to accomplish R0 resection.
(8) No prior chemotherapy, radiotherapy, and immunotherapy for any other cancers. Hormone therapy for breast cancer or prostate cancer is eligible.
(9) No previous anterior neck surgery. No previous surgery for right lung cancer.
(10) No previous treatment for esophageal cancer except for the followings;
1. Non-curative resection for the primary tumor by EMR/ESD.
2. Neoadjuvant chemotherapy defined in (4).
3. Complete resection by EMR/ESD for asynchronous multiple lesion.
(11) Major organ function is preserved.
1. WBC>=3,000/mm3
2. PLT>=100,000/mm3
3. T-bil<=1.5 mg/dL
4. AST<=100 IU/L
5. ALT<=100 IU/L
6. Creatinine of<= 1.5 mg/dL
7. SpO2>=95% (room air)
(12) Written informed consent

Exclude criteria

(1) Synchronous or metachronous (within 5 years) malignancies.
(2) Infectious disease requiring systemic treatment.
(3) Body temperature of 38 degrees Celsius or higher.
(4) Female during pregnancy, within 28 days of postparturition, or during lactation.
(5) Psychological disorder difficult to participate in this clinical study.
(6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
(7) Poorly controlled diabetes mellitus even with continuous use of insuline or hypoglycemic agents.
(8) Uncontrolled arterial hypertension.
(9) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
(10) Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
(11) Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest CT.

Related Information

• Primary Sponsor: Tsubosa Yasuhiro
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development