MI sarcoma

Phase 1

Recruiting

• Conditions: Bone and soft tissue sarcoma; sarcoma

• Registration Number: JPRN-jRCTs032220609
• Lead Sponsor: Imai Reiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-06
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Histologically diagnosed high-grade bone and soft tissue sarcomas, excluding chordoma.
2. Planning target volume is more than 400cm3.
3. Measurable target lesions in treatment-naive or recurrent cases
4. No extensive lymph node metastasis or distant metastasis.
5. PS (Performance Status) is 0 - 2.
6. Expected survival of 6 months or more.
7. Patients who understand the study and have given informed written consent to participate in this study. If the subject is a minor, the consent of a surrogate must be obtained.

Exclusion Criteria

1.Patients with serious complications.
2.Patients with active double cancer.
3.Patients who have a history of radiation therapy to the target.
4.Patients with active infection in the irradiated area.
5.Patients who are judged by the physicians in charge to be inappropriate for this study for medical or other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early adverse events in normal tissue

Secondary Outcome Measures

Name	Time	Method
tumor response rate, late adverse events in normal tissue