Dose escalation study of chemo-proton therapy for esophageal cancer

Phase 1

• Conditions: Esophageal Cancer; C159

• Registration Number: JPRN-jRCTs032180029
• Lead Sponsor: Akimoto Tetsuo

Brief Summary

To estimate the maximum tolerated dose of proton beam therapy (PBT) with concurrent Cisplatin and 5-fluorouracil chemotherapy, and to determine the recommended dose for the patients with stage IB / II / III esophageal squamous cell carcinoma. The PBT dose escalation with concurrent chemotherapy in patients with ESCC was completed without any Dose-limiting toxicity, and it signifies that a PBT with a total dose of 66 Gy (RBE) with concurrent full-dose chemotherapy is practicable.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-22
• Study Completion: 2020-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of dose limiting toxicity

Secondary Outcome Measures

Name	Time	Method
Adverse event, Complete response rate