Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04676828
Other study ID # KFE-1930
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date December 1, 2024

Study information

Verified date May 2022
Source University of Aarhus
Contact Katherina Farr, MD PhD
Phone +4550303580
Email katherina@oncology.au.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study aims to determine if functional lung avoidance based on perfusion single photon emission (SPECT)/CT scan, improves toxicity outcomes for patients with advanced lung cancer undergoing chemo-radiotherapy. Functional avoidance implies a dose plan that takes functional distribution in the lung into account, and avoids highly functional lung volumes sparing them from radiation.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 195
Est. completion date December 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Australia Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals Sydney New South Wales
Denmark Department of Oncology, Aarhus University Hospital Aarhus

Sponsors (3)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital, Westmead and Blacktown Hospital, Sydney West Radiation Oncology Network, Sydney, Australia

Countries where clinical trial is conducted

Australia,  Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiation-induced lung toxicity 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. Measured serially from 1 to 12 months after treatment completion
Secondary Quality of life Change in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnaires Measured serially from 1 to 12 months after treatment completion
Secondary Patient reported lung symptoms Change in lung symptoms according to the European Organisation for Research and Treatment of Cancer questionnaire Measured serially from 1 to 12 months after treatment completion
Secondary Progression-free survival time from randomization to disease progression at any site or death at 12 months
Secondary Overall survival time from randomization to death of any cause or last date known alive at 12 months
Secondary Loco-regional control rate freedom from local disease progression at 12 months
See also
  Status Clinical Trial Phase
Completed NCT03918538 - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors N/A
Recruiting NCT05078918 - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors N/A
Active, not recruiting NCT04548830 - Safety of Lung Cryobiopsy in People With Cancer Phase 2
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05898594 - Lung Cancer Screening in High-risk Black Women N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Terminated NCT03275688 - NanoSpectrometer Biomarker Discovery and Confirmation Study
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT06052449 - Assessing Social Determinants of Health to Increase Cancer Screening N/A
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk