Feasibility clinical study of dynamic tumor tracking VMAT and Dynamic SwingArc VMAT for primary or metastatic pulmonary or hepatic cancers, or primary pancreatic cancer.

JRCT ID: jRCTs052240112

Registered date:21/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Primary or metastatic pulmonary or hepatic cancers, or primary pancreatic cancer
• Date of first enrollment: 06/01/2025
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Dynamic tumor tracking volumetric modulated arc therapy (VMAT) and Dynamic SwingArc VMAT

Outcome(s)

• Primary Outcome: Protocol treatment completion rate
• Secondary Outcome: Dose-volume indices, quality assurance, and tracking accuracy of treatment planning, treatment time, and the incidence of grade 3 or higher acute adverse events (CTCAE v5.0).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. General eligibility criteria
1) Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
2) Patients with tumors exhibiting respiratory motion of 10 mm or larger.
3) Patients who are inoperable or refuse surgery.
4) Patients who can have gold markers placed near the tumor via bronchoscopic, percutaneous, or endoscopic approaches.
5) Patients aged 20 or older at the time of trial registration.
6) Patients from whom written informed consent can be obtained.

2. Organ-specific eligibility criteria
1) Primary/metastatic pulmonary cancer, primary/metastatic hepatic cancer
a) Solitary tumor diameter of 5 cm or less.
b) Deemed appropriate for stereotactic body radiotherapy by the attending physician.

2) Primary pancreatic cancer
a) Patients without distant metastases.
b) Deemed appropriate for concurrent chemoradiotherapy by the attending physician.

Exclude criteria

1. General exclusion criteria
1) Presence of severe infections and other serious complications.
2) Medically uncontrolled diabetes, hypertension, renal disease, or liver disease.
3) Presence of scleroderma, mixed connective tissue disease, or active systemic lupus erythematosus (SLE).
4) Women who are pregnant, may be pregnant, or are breastfeeding.
5) Inability to obtain consent for participation in the study.
6) Physician's assessment of a life expectancy of less than three months.
7) Any other condition that the principal investigator or co-investigator deems inappropriate for the study.

2. Organ-specific exclusion criteria
1) Primary/metastatic pulmonary cancer
a) Prior history of radiotherapy to the thorax.
b) Presence of active interstitial lung disease.

2) Primary/metastatic hepatic cancer
a) Prior history of radiotherapy to the upper abdomen.
b) Presence of active interstitial lung disease.

3) Primary pancreatic cancer
a) Prior history of radiotherapy to the upper abdomen.
b) Direct tumor invasion extending to the mucosal surface of the stomach, duodenum, or small intestine.

Related Information

• Primary Sponsor: Mizowaki Takashi
• Source(s) of Monetary Support: Hitachi, Ltd.,Japan Agency for Medical Research and Development