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A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local advanced non-small cell lung cancer

A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local advanced non-small cell lung cancer - A phase I/II study of chemoradiation with use of carboplatin/nab-paclitaxel and concurrent radiotherapy for local advanced non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012719
Enrollment
56
Registered
2013-12-27
Start date
2013-12-27
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

Locally Advanced Non-Small Cell Lung Cancer

Interventions

Chemoradiotherapy: Combination of weekly carboplatin plus nab-paclitaxel with concurrent thoracic radiotherapy for a total 60Gy at 2Gy/fraction/day 5times weekly for 30 times. Consolidation thera

Sponsors

Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Cytologically or histologically documented NSCLC. 2)Untreated Stage IIIA or IIIB disease 3)Unresectable 4)V20 under 35 percent and an approval of a radiotherapist by CT simulation based on the restriction of this protcol before registration. 5)Have measurable lesion 6)Patient aged 20-74 years old at the time of consent. 7)Eastern Cooperative Oncology Group Performance Status(ECOG PS) 0 or 1 8)Organ functions are met for this study within two week before study entry. 9)With signed an informed consent document

Exclusion criteria

Exclusion criteria: 1) With opposite hilar lymph nodes metastases 2) With interstitial lung disease, lung fibrosis 3) SVC syndrome 4) With active infection 5) With active double cancer 6) With other serious disease condition (bleeding, cardiac diseases, poorly controlled diabetes,etc.) 7) Clinically significant allergy 8) Patients with steroid treatment 9) Uncontrolled psychiatric disease 10) Pregnancy or lactating patients 11) Positive serum HBs antigen 12) Others

Design outcomes

Primary

MeasureTime frame
phase I:determine the recommended dose phase II:2year survival rate

Secondary

MeasureTime frame
phase I:safety, response rate, progression free survival,overall survival, completion rate of chemoradiotherapy phase II:safety, response rate, progression free survival, overall survival, completion rate of chemoradiotherapy

Countries

Japan

Contacts

Public ContactYuko Kawano

Kyushu Univiersity Hospital Respiratory Medicine

yukokawa@kokyu.med.kyushu-u.ac.jp0926425378

Outcome results

None listed

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