Radiation PneumonitisPhase 2NCT02809456
Mitigation of Radiation Pneumonitis, Fibrosis and Heart Toxicity With Nicorandil in Lung Cancer Patients
A Phase 2 study testing Nicorandil in people with Radiation Pneumonitis, run by Taipei Medical University WanFang Hospital.
Trial summary
This project will test the effect of nicorandil to mitigate the lung damage that can occur as a side effect of radiation therapy for lung cancer. Thousands of veterans develop lung cancer every year, and are treated by radiation therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Radiation Pneumonitis
- What is being tested?
- Nicorandil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically-proven NSCLC; mixed histology with small cell lung carcinoma (SCLC) component not allowed
- Patients with stage II - IV NSCLC who received at least 54 Gy of total planned thoracic radiation dose will be eligible; patients must have received at least one cycle of chemotherapy concurrently during the course of thoracic radiation; regimens allowed are platinum combinations with either etoposide or a taxane regardless of histology subtype; platinum with pemetrexed for patients with nonsquamous NSCLC only; patients with oligometastatic stage IV cancer are eligible if they have received only one line of systemic therapy for their stage IV cancer prior to the concurrent chemoradiation phase
- Patient must have had a CR/PR/SD, 4-6 weeks after completing last fraction of chemotherapy / radiation therapy.
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2 at the time of randomization
- Absolute neutrophil count (ANC) >= 1,500/uL
- Platelet count >= 100,000/uL
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- Hemoglobin >= 9 g/dL
- Total bilirubin =< 1.5 times upper limit of normal (ULN) OR direct bilirubin normal (per institute standards)
- Aspartate aminotransferase (AST) =< 1.5 x ULN; alanine aminotransferase (ALT) and AST =< 3 x ULN is acceptable if there is liver metastasis
- Fertile patients must use adequate contraception
Who cannot join
- Whole-brain radiotherapy (WBRT) < 14 days from the anticipated start of nicorandil/placebo administration
- Unable to start nicorandil/placebo treatment between 4 - 6 weeks after completing the last dose of thoracic radiation
- Active untreated brain or leptomeningeal metastases; in patients with treated central nervous system (CNS) metastases, eligible if symptoms controlled for at least 4 weeks; dexamethasone allowed if total daily dose does not exceed 2 mg
- Major injuries or surgery (e.g., craniotomy) < 28 days from the start of nicorandil/placebo administration; wound should be healed prior to starting therapy
- Second malignancies are allowed as long as the disease does not require active treatment with concomitant systemic cytotoxic chemotherapy, investigational or biologic therapy (e.g., anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA4] or human epidermal growth factor receptor 2 [HER2] monoclonal antibodies); hormone-related therapies (e.g., gonadotrophin releasing hormone (LHRH) agonists, tamoxifen, etc.) are allowed
- Concurrent uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would increase the risk associated with study participation and/or limit compliance with study requirements
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- Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher proteinuria
- Systemic therapy or investigational agent administered < 28 days prior to treatment with nicorandil
- Pregnancy or breast feeding; female patients with child-bearing potential must have a negative pregnancy test (beta-human chorionic gonadotropin [B-HCG] test in urine or serum) prior to commencing study treatment
- Creatinine > 1.5 x ULN or creatinine clearance levels (CrCL) < 45 mL/min
- Centrally located tumors with radiographic evidence (computed tomography [CT] or magnetic resonance imaging [MRI]) of local invasion of major blood vessels
- acute myocardial infarction within 2 weeks before percutaneous coronary intervention
- contraindications to treatment with nicorandil (allergy, glaucoma, digestive ulcer, is currently taking phosphodiesterase-5 inhibitor)
- bypass restenosis
- PCI history
- hypotension
- impaired liver function
- renal insufficiency requiring hemodialysis
- pregnancy
- connective tissue disease
- life expectancy ≤ 12 months
- left main coronary artery disease
- bypass graft lesion and lesions unsuitable for OCT
- unwillingness or inability to provide informed consent
About this study
This project will test the effect of nicorandil to mitigate the lung damage that can occur as a side effect of radiation therapy for lung cancer. Thousands of veterans develop lung cancer every year, and are treated by radiation therapy. Studies of lung radiation injury in laboratory animals show that with nicorandil, investigators can significantly reduce the severity of lung fibrosis and heart toxicity.1,2 Nicorandil is FDA approved and in common use for treatment of angina. These studies will advance that work to human use. Successful mitigation of lung radiation damage and heart toxicity will improve the quality of life in veterans and non-veterans who are treated for lung cancer by radiation, and may also improve cure rates of radiation therapy for lung cancer.
- Conditions
- Radiation Pneumonitis
- Being tested
- Nicorandil
- Medical subject headings
- Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicorandilDrug
Also called Ikorel, Angedil, Dancor, Nikoran,PCA
oral intake
| Study group | Role | What they receive |
|---|---|---|
| Nicorandil | Experimental | Beginning 4-6 weeks during radiation therapy, patients receive nicorandil is given during radiotherapy interval, 5mg each time, 3 times daily oral. Treatment repeats after completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Receives: Drug: Nicorandil |
| observation | Active comparator | regular radiotherapy as our protocol Receives: Drug: Nicorandil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of symptomatic radiation pneumonitis in patients with unresectable Stage II/III/ oligometastatic IV non-small cell lung carcinoma (NSCLC) who completed chemoradiation followed by nicorandil or not
Measured: Up to 2.5 years post-treatment
Secondary outcomes (6)
The quality of life (QOL) questionnaire
Measured: Baseline up to 2.5 years post-treatment
Biomarker analysis such as TGF-β, Serum surfactant proteins-A & -D, MMP1 and MMP7
Measured: Up to 97 days post-treatment
The overall survival in patients who received nicorandil versus observation
Measured: Up to 2.5 years post-treatment
Radiation pneumonitis (RP) score in patients who received nicorandil versus observation
Measured: Baseline up to 2.5 years post-treatment
The composite index (based on PFT, RP score and QOL) at the end of active treatment and 6 months after completion of treatment between patients who received nicorandil versus observation.
Measured: Baseline up to 2.5 years post-treatment
Responses rates
Measured: Up to 2.5 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation PneumonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Szu-Yuan Wu, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809456
- Sponsor's protocol ID
- N201508038
- Status last verified
- Jun 2016
- First submitted
- 9 Jun 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigation of Radiation Pneumonitis, Fibrosis and Heart Toxicity With Nicorandil in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT02809456
- Acronym / sponsor ID
- N201508038
- Conditions
- Radiation Pneumonitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will test the effect of nicorandil to mitigate the lung damage that can occur as a side effect of radiation therapy for lung cancer. Thousands of veterans develop lung cancer every year, and are treated by radiation therapy. Studies of lung radiation injury in laboratory animals show that with nicorandil, investigators can significantly reduce the severity of lung fibrosis and heart toxicity.1,2 Nicorandil is FDA approved and in common use for treatment of angina. These studies will advance that work to human use. Successful mitigation of lung radiation damage and heart toxicity will improve the quality of life in veterans and non-veterans who are treated for lung cancer by radiation, and may also improve cure rates of radiation therapy for lung cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicorandil | Experimental | Drug: NicorandilBeginning 4-6 weeks during radiation therapy, patients receive nicorandil is given during radiotherapy interval, 5mg each time, 3 times daily oral. Treatment repeats after completion of radiation therapy in the absence of disease progression or unacceptable toxicity. |
| observation | Active comparator | Drug: Nicorandilregular radiotherapy as our protocol |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically-proven NSCLC; mixed histology with small cell lung carcinoma (SCLC) component not allowed
- Patients with stage II - IV NSCLC who received at least 54 Gy of total planned thoracic radiation dose will be eligible; patients must have received at least one cycle of chemotherapy concurrently during the course of thoracic radiation; regimens allowed are platinum combinations with either etoposide or a taxane regardless of histology subtype; platinum with pemetrexed for patients with nonsquamous NSCLC only; patients with oligometastatic stage IV cancer are eligible if they have received only one line of systemic therapy for their stage IV cancer prior to the concurrent chemoradiation phase
- Patient must have had a CR/PR/SD, 4-6 weeks after completing last fraction of chemotherapy / radiation therapy.
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2 at the time of randomization
- Absolute neutrophil count (ANC) >= 1,500/uL
Key exclusion criteria (24 listed)
- Whole-brain radiotherapy (WBRT) < 14 days from the anticipated start of nicorandil/placebo administration
- Unable to start nicorandil/placebo treatment between 4 - 6 weeks after completing the last dose of thoracic radiation
- Active untreated brain or leptomeningeal metastases; in patients with treated central nervous system (CNS) metastases, eligible if symptoms controlled for at least 4 weeks; dexamethasone allowed if total daily dose does not exceed 2 mg
- Major injuries or surgery (e.g., craniotomy) < 28 days from the start of nicorandil/placebo administration; wound should be healed prior to starting therapy
- Second malignancies are allowed as long as the disease does not require active treatment with concomitant systemic cytotoxic chemotherapy, investigational or biologic therapy (e.g., anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA4] or human epidermal growth factor receptor 2 [HER2] monoclonal antibodies); hormone-related therapies (e.g., gonadotrophin releasing hormone (LHRH) agonists, tamoxifen, etc.) are allowed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicorandilAlso: Ikorel, Angedil, Dancor, Nikoran,PCAoral intake | Drug | Nicorandil, observation |
Primary outcome
The rate of symptomatic radiation pneumonitis in patients with unresectable Stage II/III/ oligometastatic IV non-small cell lung carcinoma (NSCLC) who completed chemoradiation followed by nicorandil or not
Time frame: Up to 2.5 years post-treatment
6 secondary outcomes
The quality of life (QOL) questionnaire
Time frame: Baseline up to 2.5 years post-treatment
Biomarker analysis such as TGF-β, Serum surfactant proteins-A & -D, MMP1 and MMP7
Time frame: Up to 97 days post-treatment
The overall survival in patients who received nicorandil versus observation
Time frame: Up to 2.5 years post-treatment
Radiation pneumonitis (RP) score in patients who received nicorandil versus observation
Time frame: Baseline up to 2.5 years post-treatment
The composite index (based on PFT, RP score and QOL) at the end of active treatment and 6 months after completion of treatment between patients who received nicorandil versus observation.
Time frame: Baseline up to 2.5 years post-treatment
Responses rates
Time frame: Up to 2.5 years post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicorandil in people with Radiation Pneumonitis, run by Taipei Medical University WanFang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of symptomatic radiation pneumonitis in patients with unresectable Stage II/III/ oligometastatic IV non-small cell lung carcinoma (NSCLC) who completed chemoradiation followed by nicorandil or not (time frame: Up to 2.5 years post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.