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

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

Tsubosa Yasuhiro

Shizuoka Cancer Center

1007 Shimonagakubo, Nagaizumi-Cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan

y.tsubosa@scchr.jp

Tsubosa Yasuhiro

Shizuoka Cancer Center

1007 Shimonagakubo, Nagaizumi-Cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan

+81-55-989-5222

y.tsubosa@scchr.jp

Recruiting

Aug. 07, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(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

(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.

Both

Esophageal cancer

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)

Overall survival

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.

+81-3-3542-2511

May. 24, 2022

No

none