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Pemetrexed plus radiation therapy for first-line treatment of local advanced non-small cell lung cancer (NSCLC) in 71 years old or more patients: Phase I / II study

Pemetrexed plus radiation therapy for first-line treatment of local advanced non-small cell lung cancer (NSCLC) in 71 years old or more patients: Phase I / II study - Pemetrexed + radiation therapy for elderly patients (Phase I / II study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005036
Enrollment
50
Registered
2011-02-06
Start date
2011-02-07
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

local advanced non-small cell lung cancer

Interventions

pemetrexed + radiation therapy

Sponsors

Kinki-Chuo Chest Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Local advanced stage ,Stage III 2 unable to perform surgery and able to radiation therapy, V20 < 35% 3 Histlogocally and/or cytologically proven NSCLC 4 Age: 71 years old or more 5 PS, ECOG scale: 0 to 2 6 Adequate organ function ANC >2000/mm3, Hb >9.0g/dl T-Bil <1.5mg/dl CCr >45ml/min Cr < Normal upper limit AST/ALT < 2.5 x Normal Upper limit PaO2 room air > 70mmHg 7 Written informed concent 8 over 3 months life time expectancy 9 Have the assessment lesion

Exclusion criteria

Exclusion criteria: 1 Double cancer 2 Severe hypertension 3 Have the anamnesis of heart failure or cardiac infarction 4 Uncontrolled diabetes 5 Do not adhibit the Vitamin B12 and follic acid 6 Have the interstitial change on chest X-ray or chest CT 7 Have the bacterial infection 8 Have the disturbance patients 9 Attending judge the patients not to enregister because of safety

Design outcomes

Primary

MeasureTime frame
Phase I: recommended dose of pemetrexeds Phase II: response rate

Secondary

MeasureTime frame
Phase I: progression free survival overall survival response rate Phase II: progression free survival overall survival safety

Countries

Japan

Contacts

Public ContactAkihiro Tamiya

Kinki-Chuo Chest Medical Center Thoracic Oncology

akihiro1252akihiro@yahoo.co.jp072-252-3021

Outcome results

None listed

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