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Functional image-guided intensity-modulated radiotherapy for unresectable locally advanced lung cancer

A phase II study of functional image-guided intensity-modulated radiotherapy for unresectable locally advanced lung cancer - FIGURE study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038382
Enrollment
75
Registered
2019-10-25
Start date
2019-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

Functional image-guided IMRT 60-66Gy in 30-33 fractions

Sponsors

Kochi University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed Non small cell lung cancer 2. Unresectable or refusing surgery 3. Clinical stage IIB-IIIC (UICC 8th edition) 4. Aged 20-85 years old. 5. Eastern Cooperative Oncology Group(ECOG) performance status of 0-2. 6. No previous tehrapy, such as chemotherapy, surgery, radion therapy, immune therapy for lung cancer. 7. Sufficient organ functions; fulfilling all of the following conditions within 28 days; (i) White blood cell:3000/mm3 or more (ii) Hemoglobin:8.0 g/dl or more (iii) Platelet:50000/mm3 or more (iv) Total bilirubin:2.0 mg/dl or less (v) Serum creatinine:2.0 mg/dl or less (vi) FEV1.0:700 ml or more (vii) SpO2 (room air):90% or more 8. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Synchronous or metachronous (within 3 years) malignancies. 2. Active infection requiring systemic therapy. 3. Body temperature of 38 or more degrees Celsius. 4. Women during pregnancy or possible pregnancy, within 28 days after delivery, or during breast feeding. 5. Severe mental disease. 6. Receiving continuous systemic steroid or immune-suppressive medication. 7. Idiopathic pulmonary fibrosis on CT. 8. Severe cough requiring narcotic drugs.

Design outcomes

Primary

MeasureTime frame
The incidence of Grade 3 or higher radiation pneumonitis(Common Terminology Criteria for Adverse Events ; CTCAE ver. 5.0) within 1 year after IMRT.

Secondary

MeasureTime frame
overall survival, progression-free survival, Grade 3 or higher adverse effects other than radiation pneumonitis, the relationship between dose-volume histogram(DVH) parameters and Grad 2, 3 or higher radiation pneumonitis, pulmonary function at 1 year after IMRT

Countries

Japan

Contacts

Public ContactNobuki Imano

Hiroshima University Hospital Radiation Oncology

imano@hiroshima-u.ac.jp082-257-1545

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026