Status:
RECRUITING
Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease
Lead Sponsor:
David Palma
Collaborating Sponsors:
London Health Sciences Centre
Centre Hospitalier de l'Universite de Montreal (CHUM)
Conditions:
Lung Cancer
Interstitial Lung Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this double-blind phase II randomized controlled trial, patients with lung cancer or ≤2 oligometastatic pulmonary lesions and a concomitant diagnosis of ILD who are planned for radical Radiation Th...
Detailed Description
Radiation pneumonitis (RP) is the most common and main dose-limiting toxicity after thoracic RT. RP is characterized histologically by diffuse alveolar damage and acute vascular permeability induced b...
Eligibility Criteria
Inclusion
- Lung cancer or 1-2 oligometastatic pulmonary lesions planned for radical intent radiotherapy \[minimal Biologically Effective Does (BED) of 48 Gy10 (Gray) or biological equivalent\].
- Pathologically (histologically or cytologically) proven diagnosis of cancer is not required, but strongly recommended.
- If the risk of biopsy is unacceptable, pathologic confirmation is not required providing there is growth over time on Computed Tomography (CT) imaging and/or Fluorodeoxyglucose (FDG) avidity that is strongly suggestive of malignancy.
- Fibrotic Interstitial Lung Disease (ILD) of any subtype, as diagnosed by a respirologist and confirmed by central review
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- Age ≥ 18
- Life expectancy \> 6 months
- Patients are allowed to receive anti-fibrotic agents used in the treatment of Idiopathic Pulmonary Fibrosis (IPF) or non-IPF fibrotic ILD (e.g. nintedanib, pirfenidone) and/or corticosteroids, if those are part of their current ILD treatment regimen. Other immunosuppressive drugs such as mycophenolate, azathioprine, cyclophosphamide, and rituximab must be stopped for 2 weeks prior and 2 weeks after Radiation Therapy (RT).
- Concurrent standard chemotherapy is allowed where indicated. All other systemic therapies, including biologic targeted agents or immunotherapy, or any drugs with known radiosensitive effects, must be stopped for 2 weeks prior and 2 weeks after treatment.
Exclusion
- Prior lung radiotherapy
- Current use of oral or intravenous corticosteroids
- Plans for the patient to receive other local therapy to the target lesion(s) while on this study, except at disease progression
- Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy
- Pregnancy
- If not pregnant, use of effective contraception methods for women of childbearing age is required which can include:
- hormonal methods (e.g. oral, injected, implanted),
- placement of an intrauterine device,
- barrier methods (i.e. condoms),
- sterilization of the partner (e.g. previous vasectomy)
- abstinence
- Women who become pregnant should stop taking NAC and/or dexamethasone and inform their study doctor.
- Male participants should use adequate forms of birth control with their partners.
- Currently breastfeeding
- Current or recent use of NAC
- Contraindications to dexamethasone or N-Acetyl Cysteine (NAC). These include:
- Previous intolerance or allergy to dexamethasone or NAC
- Scleroderma
- Active infection
- Glaucoma
- Psychiatric disorder that could be exacerbated by dexamethasone
- Cystinuria
- Any other condition that the treating physician believes to be a contraindication to dexamethasone or NAC
Key Trial Info
Start Date :
January 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05986318
Start Date
January 7 2025
End Date
December 31 2032
Last Update
December 4 2025
Active Locations (2)
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1
London Regional Cancer Program, London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
2
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2X 0A9