Phase I Dose-Escalation Study of Accelerated Hyperfractionation and Intensity-modulated Radiation Therapy in Patients with Locally Advanced Non Small Cell Lung Cancer

Phase I Dose-Escalation Study of Accelerated Hyperfractionation and Intensity-modulated Radiation Therapy in Patients with Locally Advanced Non Small Cell Lung Cancer - Phase I Dose-Escalation Study of AHF and IMRT in Patients with Locally Advanced NSCLC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034543

Enrollment

Registered

2018-11-01

Start date

2018-09-01

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 carcinoma (NSCLC)

Interventions

Chemoradiotherapy consists of CBDCA (AUC2, day 1, 8, 15, 22), PTX (40 mg/m2, day 1, 8, 15, 22) and AHF and IMRT (56-72 Gy/40 fr:56 Gy/40 fr at level 0, 60 Gy at level 1, 64 Gy at level 2, 68 Gy at lev

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven NSCLC 2) Clinical stage IIIA or IIIB Locally Advanced NSCLC 3) Aged 20 to 90 years old, ECOG Performance status 0 or 1 4) Without previous chemotherapy for primary illness 5) Without previous radiotherpy for chest 6) Adequate organ functions 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy 2) Active infection requiring systemic therapy 3) With severe complications 4) History of serious drug allegies 5) Patients with unstable and uncontrollable diabetic mellitus, hypertension, kidney disease, liver disease. 6) Patients with intersitial pneumonia or pulmonary fibrosis detectable on chest radiography 7) Women during pregnancy or breast-feeding, or patients who wish pregnancy 8) Patients that physicians consider inappropriate for this study

Design outcomes

Primary

Measure	Time frame
incidence of Grade 3 or more acute adverse events within 90 days after chemoradiotherapy	—

Countries

Japan

Contacts

Public ContactNoriko Kishi

Graduate School of Medicine, Kyoto University Department of Radiation Oncology and Image-applied Therapy

kishin@kuhp.kyoto-u.ac.jp075-751-3762

Outcome results

None listed

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