Nitroglycerin as a sensitizer in the treatment of non small cell lung cancer: ;a phase II trial.

Nitroglycerin as a sensitizer in the treatment of non small cell lung cancer: ;a phase II trial. - Nitroglycerine phase II

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39504

Enrollment

Registered

2011-10-11

Start date

2011-12-20

Completion date

Unknown

Last updated

2024-05-06

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 NSCLC

Interventions

* Day 1: - Dynamic Contrast Enhanced (DCE) CT scan at radiology department before HX-4 scan - Injection of HX-4 at nuclear medicine department - Static HX-4 PET-CT scan 240 minutes post-injection Th

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Non-small cell lung cancer stage IB-IV amenable for radiotherapy with curative intent. - (Stage IV patients with oligometastatic (1-4 metastases) NSCLC are regularly treated radically in the IKL region) - Patients not included in the PET-boost trial. - WHO performance status 0-2 - Willing and able to comply with the study prescriptions - 18 years or older - Ability to give and having given written informed consent before patient registration - No recent (less than 3 months) severe cardiac disease (NYHA class higher than 1) (congestive heart failure, infarction) - No radiotherapy in 4 weeks prior to this study - No treatment with investigational drugs in 4 weeks prior to or during this study. - No known allergy to nitroglycerin or nitroglycerin patch. - No known allergy to iodine based contrast agents - No use of vaso-dilators (calcium channel blockers, nitrates or 5-fosfodiesterase inhibitors) - No symptomatic hypotension - No other active malignancy - No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy) in previous 4 weeks - Adequate renal function: calculated creatinine clearance at least 60 ml/min

Exclusion criteria

Exclusion criteria: The opposite of the above

Design outcomes

Primary

Measure	Time frame
- Demonstrate an absolute increase in 2 year overall survival of 15 % vs historical controls	—

Secondary

Measure	Time frame
- Decrease of hypoxia (less uptake of HX-4 in the tumor) on PET-scan described by TBR - Tumor perfusion (of the largest lesion tumor/ node) on DCECT-scan described by Whole tumour Blood Volume and Tumour Permeability - Evaluating prognostic effect of perfusion and hypoxia values in patients treated with nitroglycerin. - Acute toxicity (CTC AE 4.0) - Evaluate response on an 18-FDG PET-CT scan 2.5 months after the end of treatment and correlate these findings with pre-radiotherapy FDG / hypoxia PET-scans and perfusion CT scans.	—

Measure

Time frame

- Decrease of hypoxia (less uptake of HX-4 in the tumor) on PET-scan described by TBR - Tumor perfusion (of the largest lesion tumor/ node) on DCECT-scan described by Whole tumour Blood Volume and Tumour Permeability - Evaluating prognostic effect of perfusion and hypoxia values in patients treated with nitroglycerin. - Acute toxicity (CTC AE 4.0) - Evaluate response on an 18-FDG PET-CT scan 2.5 months after the end of treatment and correlate these findings with pre-radiotherapy FDG / hypoxia PET-scans and perfusion CT scans.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)