Phase I study of definitive CRT with paclitaxel, CDDP and 5-FU for clinical stage IA-IIIC esophageal cancer.(PCF-RT)

JRCT ID: jRCTs051180082

Registered date:28/02/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 01/07/2017
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Concurrent chemoradiotherapy with paclitaxel, cisplatin and 5-FU

Outcome(s)

• Primary Outcome: DLT occurrence rate at each dose level
• Secondary Outcome: Overall survival, Progression free survival, Adverse event

Key inclusion & exclusion criteria

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

Include criteria

1) Histologically proven squamous cell carcinoma, or adenosquamous cell carcinoma or basaloid of the esophagus
2) Primary lesion are located within the cervical esophagus (Ce) and the abdominal esophagus (Ae)
3) Aged 20 to 75 years old
4) ECOG PS of 0 or 1
5) Clinical stage IA - IIIC
6) No need for measurable lesion
7) No previous treatment of esophageal cancer except endoscopic surgery
8) No palsy of recurrent nerve
9) No adaptation of surgery or refused esophagectomy
10) Adequate organ functions
11) Written informed consent

Exclude criteria

1) Simultaneous or metachronous double cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer or expected cure in surgery
2) history of radiotherapy for mediastinum
3) Uncontrollable diabetes mellitus
4) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac function disorder
5) Uncontrollable arrhythmia
6) Patients requiring systemic steroids medication
7) Liver cirrhosis
8) Active bacterial or fungous infection
9) With a history of grade 2-4 allergic reaction by CTCAE version 4.0
10) With a history of grade 2-4 nerve disturbance by CTCAE version 4.0
11) With blood transfusion within 2weeks and/or active bleeding
12) Interstitial pneumonia, fibroid lung or severe emphysema
13) With a history of allergic reaction to platinum, polyoxy-ethilen oil, hydrogenated castor oil or polysorbate 80
14) Psychosis
15) Pregnant or lactating women, women of childbearing potential or men who like to have children in future
16) Any patients judged by the investigator to be unfit to participate in the study

Related Information

• Primary Sponsor: Yamamoto Sachiko