Photodynamic Therapy for the Prevention of Lung Cancer

NCT03346304 | Withdrawn Phase 2 DMC

• 1 other identifier: UCL/13/0390
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

PEARL is a phase III multicentre 2:1 randomised controlled trial, with an incorporated phase II (pilot) component. All patients consented/registered onto the trial will have an autofluorescence bronchoscopy (AFB) to check for the presence of high grade lesions (HGLs) in the lung, as verified by tissue biopsy. Only patients with one or more histologically confirmed lung HGL will be randomised to receive either photodynamic therapy (PDT) treatment with surveillance (=intervention), or surveillance alone (=control). The overall aim of the phase II pilot is to demonstrate a \>20% response in the PDT group (at least 3 out of 21 PDT patients), compared to a minimum response of 5%. This will be used as an efficacy signal to determine whether the trial will continue into phase III. Response will be measured by regression of high grade lesions (HGLs) to either low grade lesions (LGLs), or to normal epithelium at 6 months post treatment (blind assessment). The overall aim of the phase III is to show that the time period over which HGLs progress to invasive lung cancer is significantly longer when treated with PDT compared to surveillance alone.

Conditions

Squamous Cell Lung Cancer; Lung Cancer

Keywords

Autofluorescence Broncoscopy (AFB); Photodynamic Therapy (PDT); High Grade Lesions (HGLs); lung cancer; photosensitiser; Fotolon

Outcome Measures

Primary Outcomes (1)

• Time to site-specific progression

  of high grade lesions in the lung to invasive lung cancer; compared between the PDT and control groups

  within a 3-year follow-up (incorporates patients from phase II)

Secondary Outcomes (10)

• Site-specific response

  within a 3-year follow-up (incorporates patients from phase II)

• Number of new HGLs

  within a 3-year follow-up (incorporates patients from phase II)

• Number of metachronous endobronchial lung cancers

  within a 3-year follow-up (incorporates patients from phase II)

• Cumulative risk of developing lung cancer

  within a 3-year follow-up (incorporates patients from phase II)

• Overall and cancer specific survival

  within a 3-year follow-up (incorporates patients from phase II)

Study Arms (2)

PDT treatment (Intervention Arm)

EXPERIMENTAL

Patients randomised to the PDT treatment (Intervention Arm) will have two courses of PDT treatment in total (for each lung treated). Follow-up is the same as for Control Arm patients: an AFB at 6, 12, 24, and at 36 months post-randomisation; with further AFB visits at 18 and/or at 30 months post-randomisation (dependent on lesion appearance).

Other: Photodynamic Therapy (PDT)

Surveillance (Control Arm)

NO INTERVENTION

Patients randomised to the surveillance (Control Arm) will have: an AFB at 6, 12, 24, and at 36 months post-randomisation; with further AFB visits at 18 and/or at 30 months post-randomisation (dependent on lesion appearance).

Interventions

Photodynamic Therapy (PDT) OTHER

Photodynamic Therapy (PDT) using photosensitiser drug Fotolon

PDT treatment (Intervention Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Absence of metastatic disease or other primary cancers as confirmed by CT thorax within 28 days prior to registration only)
• Male or female patients ≥18 years of age
• No upper age limit but life expectancy must be at least 3 years
• ECOG Performance Score 0-2
• FEV1 ≥ 25% of predicted
• DLCO/TLCO ≥ 20% of predicted (within 28 days prior to registration only)
• Women of child-bearing potential (WOCBP), or men with female partners who are pregnant or WOCBP must be willing to practise highly effective methods of birth control starting as soon as possible from the time of informed consent and registration until randomisation (if randomised to the control arm), or until 3 months after the end of their last PDT treatment (if randomised to the intervention arm) . Male patients must also advise their female partners who are WOCBP regarding contraceptive requirements as listed for female patients who are WOCBP.
• Patients who are WOCBP must also have a negative pregnancy test at the following time points:
• within 14 days prior to registration
• within 21 days prior to randomisation
• and within 24 hours prior to 1st and 2nd PDT treatment, for each lung treated (only if randomised to PDT arm)
• Ability to give informed consent including the donation of biological samples for translational research
• PRE-RANDOMISATION: Finding of (micro)-invasive disease on histology
• HGLs present for ≥5 years which have remained stable on autofluorescence bronchoscopy (AFB) surveillance
• Detection of active cancer or on systemic treatment for cancer, excluding basal cell skin cancers (unless adjacent to the illumination site)

Sponsors & Collaborators

• University College, London: lead

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: September 1, 2018
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share