IMRT feasibility study for stage III NSCLC

Phase 2

• Conditions: Clinical stage 3 non-small-cell lung cancer; NSCLC inoperable

• Registration Number: JPRN-jRCTs042180119
• Lead Sponsor: Harada Hideyuki

Brief Summary

The primary endpoint for tolerability of chemoradiotherapy with intensity-modulated radiotherapy could not be achieved. However, intensity-modulated radiotherapy could be completed in all but one case, demonstrating good survival and safety.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-19
• Study Completion: 2019-05-11
• Results First Posted: 2022-03-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1)Non-small cell lung cancer(NSCLC) diagnosed by cytological or histological examination
2)Inoperable
3)Clinical stage 3 NSCLC, possible for definitive radiotherapy
4)No previous chemotherapy or radiotherapy
5)Measurable lesions
6)Age; 20 -75 years old
7)ECOG performance status:0-1
8)Ingestible
9)Sufficient function in bone marrow, heart, lung, liver and kidney
10)Written informed consent

Exclusion Criteria

1)Active double cancer
2)Severe infection or morbidity
3)HBs antigen positive
4)Previous thoracic radiotherapy
5)Interstitial pneumonia or fibrosis on CT
6)Severe emphysema or chronic bronchitis or asthma
7)Severe drug allergy
8)Severe diabetes
9)Unstable angina or myocardial infarction within 6 months
10)Febrile more than or equal to 38 degree
11)Systemic use of corticosteroid or immunosuppressive drug
12)Expectant mother or breast feeding woman or not agreed with contraception
13)Psychiatric disorder
14)Unsuitable for enrollment judged by attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion rate of treatment

Secondary Outcome Measures

Name	Time	Method
Overall survival, Progression free survival, Toxicities