Phase I/II study of bi-weekly DCS as first-line therapy for advanced esophageal cancer.

JRCT ID: jRCTs031180376

Registered date:19/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 04/10/2017
• Target sample size: 38
• Study type: Interventional

Intervention(s)

The phase I part of the study is a dose-escalation study using a standard 3 plus 3 design as following:
Level 1. Docetaxel 30mg/m2, cisplatin 60mg/m2, S-1 80-120mg/body)
Level 2. Docetaxel 30mg/m2, cisplatin 70mg/m2, S-1 80-120mg/body)
Level 3. Docetaxel 30mg/m2, cisplatin 80mg/m2, S-1 80-120mg/body)
In the phase II study, treatment is conducted on dose of RD.

Outcome(s)

Primary Outcome

PhaseI part: DLT
PhaseII part:PFS

Secondary Outcome

PhaseI part: Adverse Event ,Response Rate
PhaseII part: Overall survival(OS), Response rate(RR), Adverse Event, Quality of life(QOL),non deterioration rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Primary tumor located cervical esophagus (Ce) or thoracic esophagus (Te) according to the 7th UICC-TNM classification
2)Histologically confirmed esophageal squamous cell carcinoma, adenosquamous carcinoma, or basal cell carcinoma
3)Unresectable advanced or recurrent tumor with no indication for definitive treatment (surgery, radiotherapy, and chemoradiotherapy)
4)Age over 20 years old.
5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
6)Without symptomatic bone or brain metastases
7)Without massive pleural effusion (more than half of one side thoracic cavity) nor massive ascites (more than from pelvic cavity to upper abdomen)
8)With evaluable lesions according to RECIST ver 1.1 (measurable lesions not required)
9)As for previous therapy for esophageal cancer,either A) or B) must be fulfilled:
A) When preoperative chemotherapy or postoperative chemotherapy was given as previous therapy, meet all of the following 3 factors:
a. Recurrence was detected more than 12 weeks after previous therapy was completed.
b. Previous therapy was not terminated due to adverse events, patient refusal. Tumor response by previous therapy was not judged as disease progression.
c. Total dose of prior CDDP =<210 mg/m2.
10)Adequate organ functions as following:
Absolute neutrophil count >=1,500/mm3
Platelet count >=100,000/mm3
Hemoglobin level >=9.0g/dL
Total bililubin =<1.5mg/dL
Aspartate aminotrasferase (AST) =<100IU/L (in the case or liver metastases, =<200IU/L) .
Alanine aminotransferase (ALT) =<100IU/L (in the case or liver metastases, =<200IU/L) .
Serum creatinine =<1.5mg/dL
eGFR >=60ml/min/1.73m2 (Phase I), eGFR >=30ml/min/1.73m2 (Phase II)
11)Written informed consent

Exclude criteria

1)Synchronous or metachronous (within 5 years) double cancers, except for intoramucosal tumor curatively resected by local therapy
2)With active systemic infection disease
3)With active hepatitis B or C
4)With HIV infection
5)With a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis
6)Severe psychological illness.
7)With continuous systemic steroid or immune-suppressive drug therapy.
8)Poorly controlled diabetes mellitus or thyroid diseases.
9)Unstable angina within 3 weeks or with a history of acute myocardial infarction within 3months
10)With history of hypersensitivity to docetaxel, cisplatin or polysorbate 80-containing formulations
11)Pregnant and/or nursing women or men who wish to have children in future
12)Judged to be unfit to participate in this study by investigator

Related Information

• Primary Sponsor: Yagi Koichi
• Secondary ID(s): UMIN000032257