Dose escalation study of chemo-proton therapy for esophageal cancer

JRCT ID: jRCTs032180029

Registered date:22/10/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Esophageal Cancer
• Date of first enrollment: 12/02/2015
• Target sample size: 12
• Study type: Interventional

Intervention(s)

Chemoradiation (chemotherapy 2 cycle + concurrent proton beam therapy)
5-FU: 1000mg/m2/day given on day 1 to 4, 29 to 32
CDDP: 75mg/m2 given on day 1, 29
Proton beam therapy 60 to 66CGy in 30 to 33 fractions. 1 fraction / day
Additional chemotherapy (2 cycle every 28 days)
5-FU: 1000mg/m2/day given on day 1 to 4
CDDP: 75mg/m2 given on day 1

Outcome(s)

• Primary Outcome: Proportion of dose limiting toxicity
• Secondary Outcome: Adverse event, Complete response rate

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
2) Primary lesion are located within the thoracic esophagus
3) Clinical stage IB or II or III (non-T4)
4) Aged 20 to 75 years old
5) ECOG PS of 0 or1
6) adequate organ functions
7) no previous treatment of esophageal cancer except EMR or ESD
8) no previous chemotherapy or radiotherapy against any other malignancies
9) written informed consent

Exclude criteria

1. Active double cancer
2. Active infection
3. Body temperature is under 38 centigrade
4. Possible pregnancy
5. Severe psychological disease
6. Systemic steroid user
7. Positive HBs antigen
8. Uncontrolled diabetes
9. Uncontrolled hypertension
10. Unstable angina, cardiac infarction within 6 months before enrollment
11. Interstitial pneumonitis, pulmonary fibrosis, severe emphysema, heart failure
12. Cerebrovascular disease within 6 months before enrollment
13. History of iodine allergy

Related Information

• Primary Sponsor: Akimoto Tetsuo
• Secondary ID(s): UMIN000015550