JCOG1314: A randomized controlled phase III study comparing docetaxel, CDDP and 5-FU with CDDP and 5-FU in patients with metastatic or recurrent esophageal cancer

JRCT ID: jRCTs031180143

Registered date:21/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: esophageal cancer
• Date of first enrollment: 17/09/2014
• Target sample size: 240
• Study type: Interventional

Intervention(s)

A: Receiving cisplatin (80 mg/m2, 2-h intravenous infusion on day 1) and fluorouracil (800 mg/m2, 24-h continuous intravenous infusion on days 1-5), repeated every 4 weeks
B: Receiving docetaxel (30 mg/m2, 1-h intravenous infusion on day 1 and 15), cisplatin (80 mg/m2, 2-h intravenous infusion on day 1) and fluorouracil (800 mg/m2, 24-h continuous intravenous infusion day on days 1-5), repeated every 4 weeks

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Progression-free survival, response rate, proportion of adverse events

Key inclusion & exclusion criteria

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

Include criteria

1)Primary tumor located at cervical esophagus, thoracic esophagus or esophago-gastric junction (the UICC 7th edition)
2)Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma or basaloid carcinoma (Only Siewert type I is eligible in case of adenosquamous carcinoma or adenocarcinoma.)
3)Unresectable or recurrent esophageal cancer with no indication for surgery, radiotherapy, and chemoradiotherapy
A)In case of unresectable esophageal cancer, all of the following conditions must be fulfilled:
i)Having metastatic lesion except for #102 or #104 metastases
ii)cT1-cT4a
iii)Dysphagia score =<2 and no stenosis which endoscope does not pass through
B)In case of recurrent esophageal cancer, all of the following conditions must be fulfilled:
i)Having metastatic lesion except for #102 or #104 metastases
ii)Dysphagia score =<2
4)Aged 20 to 75 years old
5)ECOG PS of 0 or 1
6)No symptomatic bone or brain metastases
7)No massive ascites/pleural effusion
8)Measurable lesions not required
9)As for previous therapy,the following regimens are eligible. And, either A) or B) must be fulfilled.
A)When preoperative chemotherapy (CF, CS, or DCF regimen) or postoperative chemotherapy (CF, or S-1 regimen) was given as previous therapy, meet all of the following 4 factors:
i)Recurrence was detected more than 24 weeks after previous therapy was completed
ii)Previous therapy was not terminated due to adverse events, patient refusal, andtumor response by previous therapy was not judged as disease progression
iii)Total dose of prior CDDP =< 210 mg/m2
iv)Total dose of prior DOC =< 210 mg/m2
B)When preoperative chemoradiotherapy (CF-RT), concurrent chemoradiotherapy (CF-RT, CS-RT, or DCF-RT) or radiotherapy alone were received as previous therapy, meet all of the following 5 factors:
i)More than 52 weeks after radiotherapy when lung was involved in radiation field
ii)No history of grade 2-4 pneumonitis
iii)Previous therapy was not terminated due to adverse events, patient refusal, andtumor response by previous therapy was not judged as disease progression
iv)Total dose of prior CDDP =< 210 mg/m2
v)Total dose of prior DOC =< 210 mg/m2
10)Sufficient organ function
11)Written informed consent

Exclude criteria

1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Active infection requiring systemic therapy.
3) Pregnancy, possible pregnancy, within 28 days after delivery or breastfeeding.
4) Psychological disorder difficult to participate in this clinical study .
5) Patients requiring systemic steroid medication.
6) Under treatment with flucytosine, phenytoin, or warfarin.
7) History of hypersensitivity to DOC, CDDP, or polysorbate 80.
8) Poorly controlled diabetes mellitus.
9) Severe pulmonary fibrosis or emphysema.
10) Poorly controlled hypertension.
11) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months.
12) Positive HBs antigen, or positive HIV antibody

Related Information

• Primary Sponsor: TSUBOSA Yasuhiro
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000015107