JCOG0909: A non-randomized confirmatory study of definitive chemoradiotherapy including salvage treatment in patients with clinical stage II/III esophageal carcinoma

JRCT ID: jRCTs031180110

Registered date:08/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: esophageal neoplasm
• Date of first enrollment: 30/06/2010
• Target sample size: 95
• Study type: Interventional
• Intervention(s): Chemoradiotherapy: consists of 5-FU (1,000 mg/m2, day1-4, day29-32), cisplatin (75 mg/m2, day1,29) and radiotherapy (50.4 Gy/28Fr), followed by additional two courses chemotherapy with 5-FU (1,000 mg/m2, day1-4) plus cisplatin (75 mg/m2, day1). Salvage therapy including salvage surgery and/or salvage endoscopic mucosal resection is applied if the patient has residual tumor or recurrent tumor after definitive chemoradiotherapy.

Outcome(s)

• Primary Outcome: Proportion of 3-year overall survival
• Secondary Outcome: progression-free survival, complete response rate, esophagectomy-free survival, adverse events, delayed toxicity, salvage treatment related toxicity

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma by endoscopic biopsy from esophageal primary tumor
2) All lesions located (primary tumor, esophageal intramural metastases, and intraepithelial spread) in the thoracic esophagus (the 6th edition of the UICC TNM classification)
3) Clinical stage II or III without T4
4) Aged 20 to 75 years old
5) ECOG Performance status 0 or 1
6) No previous therapy against esophageal cancer except for the following cases
(i) Complete resection by EMR/ESD (diagnosed as pT1a-EP (M1) or pT1a-LPM (M2) tumors)
(ii) Complete resection by EMR/ESD (diagnosed as pT1a-MM (M3) tumor without lymphovascular invasion)
7) Neither previous chemotherapy, chemoradiotherapy, nor radiotherapy against any cancers except for hormonal therapy for prostate cancer with more than 5 years of disease-free interval
8) Adequate organ functions
9) Patients do not have a preference to receive a surgical resection as an initial therapy including preoperative chemotherapy, but agree to receive a salvage treatment including surgery when the disease is residual or recurrent
10) Written informed consent

Exclude criteria

1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Active infection requiring systemic therapy
3) Fever over 38 degrees Celsius
4) Pregnant or lactating women or women of childbearing potential
5) Psychiatric disease or symptom
6) Patients requiring systemic steroids medication (internal or intravenous use)
7) Serum HBs antigen positive (the data within 1 year before the registration)
8) Uncontrollable diabetes mellitus with HbA1c of 7.0% or higher
9) Uncontrollable hypertension
10) Unstable angina (onset or worse heart attack of angina within 3 weeks,) or with a history of myocardial infarction within 6 months.
11) Interstitial pneumonia, fibroid lung, or severe emphysema
12) With a history of cerebrovascular disorder (brain infarction, intracerebral bleeding, or transient cerebral ischemia attack) within 6 months
13) Drug allergy for iodic drug

Related Information

• Primary Sponsor: KITAGAWA Yuko
• Source(s) of Monetary Support: National Cancer Center Japan,Ministry of Health, Labour and Welfare,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000003534