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Single Arm Phase II Trial of Nitroglycerin Plus Docetaxel in Elderly Untreated Stage IIIB/IV Non-small-cell Lung Cancer

Single Arm Phase II Trial of Nitroglycerin Plus Docetaxel in Elderly Untreated Stage IIIB/IV Non-small-cell Lung Cancer - Single Arm Phase II Trial of Nitroglycerin Plus Docetaxel in Elderly Untreated Stage IIIB/IV Non-small-cell Lung Cancer (TUTRCDC003)

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001820
Enrollment
40
Registered
2009-03-31
Start date
2009-03-01
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

Transdermally applied nitroglycerin (10 mg/day) for consecutive 5 days between 3 days before start of chemotherapy using 60 mg/m2 of docetaxel (D1) every 3 weeks and the day 2 of chemotherapy

Sponsors

Tohoku University Translational Research Center
Lead Sponsor
Tohoku University Hospital, Shinshu University Hospital, Shiga Medical Center for Adults, Kyoto University Hospital, Osaka Police Hospital, Takatsuki Red Cross Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (a) The diagnosis of non-small cell lung cancer was confirmed with histological or cytological examination; (b) Stage IIIB or stage IV; (c) A measurable or evaluable tumor lesion according to WHO criteria; (d) Good performance status: a performance status (PS) of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale; (e) Adequate hepatic function (serum bilirubin < 1.5 x LN, ALT, and AST < 2.5 x LN); (f) Adequate hematologic function (neutrophil count > 2,000/µL, hemoglobin > 9g/dL, platelet count> 100,000/µL); (g) Adequate cardiac function (cardiothoracic ratio< 60%); (h) Informed consent to receive chemotherapy and attend this study was obtained; (i) Scheduled treatment with chemotherapy and without radiotherapy; (j) Systolic blood pressure: equal to or more than 90mmHg (k) Prognosis: equal to or more than 3 months

Exclusion criteria

Exclusion criteria: (a) No treatment with a vasodilator such as calcium channel blockers (b) No prior chemotherapy or radiotherapy; (c) Without uncontrollable brain metastasis; (d) No ischemic heart disease; (e) Without active interstitial pneumonitis (f) Without uncontrollable massive pleural effusion or pericardial effusion (g) Without pregnancy or nurse (h) No enrollment in another interventional study

Design outcomes

Primary

MeasureTime frame
(1) response rate—

Secondary

MeasureTime frame
(1) Progression free survival (2) Frequency of toxicities (3) Overall survival (4) Change in plasma vascular endothelial growth factor level during nitroglycerin treatment for 3 days before chemotherapy as an indicator for response to nitroglycerin plus docetaxel and cisplatin regimen—

Countries

Japan

Contacts

Public ContactHiroyasu Yasuda

Tohoku University Translational Research Center Department of clinical application

yasuda@trc.med.tohoku.ac.jp022-717-7122

Outcome results

None listed

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