Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer (ASPECT)
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| ClinicalTrials.gov Identifier: NCT04676828 |
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Recruitment Status :
Recruiting
First Posted : December 21, 2020
Last Update Posted : May 20, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer Radiation-Induced Disorder Radiation Pneumonitis Pulmonary Disease Lung Function Decreased | Diagnostic Test: Single-photon-emission CT scan | Not Applicable |
In this project, a novel method of safe radiotherapy delivery shall be tested for patients with lung cancer in a clinical setting. Functional avoidance radiotherapy is a new method that protect highly functional lung tissue from radiation, while delivering high dose radiotherapy to the lung tumour. Radiotherapy is usually based on a CT scan that does not account for functional variations in the lungs. Therefore, I hypothesize that using functional distribution in the lungs and avoiding irradiation of highly functional lung will improve treatment outcome for individual patients with lung cancer.
The objective of my project is to determine if functional image guided radiotherapy (functional avoidance radiotherapy) improves toxicity outcomes for patients with lung cancer undergoing curative chemo-radiotherapy in a prospective clinical trial.
To reach this objective, the impact of functional avoidance radiotherapy on pulmonary toxicity measured by the incidence and severity of radiation-induced lung disease shall be assessed. Additionally, loco-regional control, time to progression, overall survival, quality of life and radiation-induced molecular response in patients treated with functional avoidance radiotherapy shall be assessed and compared to patients receiving standard treatment.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 195 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized double-blinded phase 2 |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Masking Description: | Participants, care providers and outcome assessors are blinded |
| Primary Purpose: | Treatment |
| Official Title: | Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial |
| Actual Study Start Date : | December 1, 2020 |
| Estimated Primary Completion Date : | December 1, 2023 |
| Estimated Study Completion Date : | December 1, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SPECT functional avoidance treatment
SPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation.
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Diagnostic Test: Single-photon-emission CT scan
SPECT/CT scan is an established functional modality used in the diagnosis and monitoring of lung disease. SPECT/CT scan images pulmonary circulation, where perfused areas equate with normal functional lung |
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No Intervention: Standard treatment
CT-based radiation therapy given over 5- 6.5 weeks.
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- Radiation-induced lung toxicity [ Time Frame: Measured serially from 1 to 12 months after treatment completion ]crude rate of symptomatic radiation-induced lung toxicity of grade 2 and higher. According to the Common Toxicity Criteria for Adverse Events version 5.0 for radiation pneumonitis, dyspnea, cough, or any other radiation-induced respiratory, thoracic and mediastinal disorder.
- Quality of life [ Time Frame: Measured serially from 1 to 12 months after treatment completion ]Change in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnaires
- Patient reported lung symptoms [ Time Frame: Measured serially from 1 to 12 months after treatment completion ]Change in lung symptoms according to the European Organisation for Research and Treatment of Cancer questionnaire
- Progression-free survival [ Time Frame: at 12 months ]time from randomization to disease progression at any site or death
- Overall survival [ Time Frame: at 12 months ]time from randomization to death of any cause or last date known alive
- Loco-regional control rate [ Time Frame: at 12 months ]freedom from local disease progression
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- histologically verified lung cancer (small-cell and non-small cell lung cancer)
- referred for radiotherapy with curative intent
- radiation dose of 60-66 Gy given in 2-Gy fractions, other dose levels and fractionation schedules accepted, as per site standard
- concurrent chemotherapy is accepted
- patients with oligometastatic disease are allowed, where metastasis have been ablated with surgery or radiotherapy
- receiving (chemo)-radiotherapy to the thoracic disease with curative intent
- adults over 18, that have given oral and written informed consent before patient registration.
Exclusion Criteria:
- concurrent immunotherapy
- previous radiotherapy to the thorax
- other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676828
| Contact: Katherina Farr, MD PhD | +4550303580 | katherina@oncology.au.dk |
| Australia, New South Wales | |
| Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals | Not yet recruiting |
| Sydney, New South Wales, Australia, 2145 | |
| Contact: Eric Hau, MBBS PhD 0432207880 Eric.Hau@health.nsw.gov.au | |
| Sub-Investigator: Eric Hau, MBBS PhD | |
| Denmark | |
| Department of Oncology, Aarhus University Hospital | Recruiting |
| Aarhus, Denmark, DK-8000 | |
| Contact: Azza Khalil, MD, PhD 004578465000 azza.khalil@auh.rm.dk | |
| Contact: Line Sparvath 004578465000 linspa@rm.dk | |
| Principal Investigator: Katherina Farr, MD, PhD | |
| Sub-Investigator: Azza Khalil, MD, PhD | |
| Responsible Party: | Katherina Farr, MD, PhD, Specialist in Clinical Oncology, Aarhus University Hospital |
| ClinicalTrials.gov Identifier: | NCT04676828 |
| Other Study ID Numbers: |
KFE-1930 |
| First Posted: | December 21, 2020 Key Record Dates |
| Last Update Posted: | May 20, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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radiation-induced lung toxicity functional avoidance methodology radiation therapy of lung cancer |
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Pneumonia Lung Neoplasms Radiation Pneumonitis Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Infections Lung Diseases, Interstitial Lung Injury Radiation Injuries Wounds and Injuries |