MI sarcoma

JRCT ID: jRCTs032220609

Registered date:06/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Bone and soft tissue sarcoma
• Date of first enrollment: 09/11/2023
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Multi-ion radiotherapy

Outcome(s)

• Primary Outcome: Early adverse events in normal tissue
• Secondary Outcome: tumor response rate, late adverse events in normal tissue

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Imai Reiko