- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01138748
Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers (PEARL-2)
Surgical resection with mediastinal lymph node sampling is currently the therapy of choice for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This has shown to result in a long term local disease control rate and a high cancer specific survival.
The current trial addresses the issue if progression free survival (PFS) in patients treated with radiotherapy can be predicted by a multi-variate model derived from a composite of bio-imaging and biomarkers
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Ghent, Belgium
- University Hospital Ghent
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Proof of cT1a/b - 2a/b N0M0 NSCLC
- Informed Consent signed
- Resectable tumour
- > 18 years old
- men and women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiation therapy
|
hypofractionated radiation therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
development and validation of a multi-variate predictive model
Time Frame: from 2 to 5 years
|
To develop and validate a multi-variate predictive model based on bio-imaging and biomarkers for progression)free survival from 2 to 5 years.
|
from 2 to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the clinical response and complication rate
Time Frame: from 2 to 5 years
|
from 2 to 5 years
|
local, regional or distant failure
Time Frame: from 2 to 5 years
|
from 2 to 5 years
|
progression free survival
Time Frame: from 2 to 5 years
|
from 2 to 5 years
|
disease specific overall survival
Time Frame: from 2 to 5 years
|
from 2 to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jan Van Meerbeeck, MD,PhD, University Hospital, Ghent
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010/205
- LONG 10-01 (Other Identifier: University Hospital Ghent)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inoperable Early Stage Non-small Cell Lung Cancer
-
Kael-GemVax Co., Ltd.Quintiles, Inc.UnknownInoperable Stage III Non-small Cell Lung Cancer
-
Washington University School of MedicineCompletedInoperable Stage I/II Non-small Cell Lung CancerUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
University of Rome Tor VergataCompletedEarly Stage Non-small-cell Lung Cancer (Stage 1-2)Italy
-
Washington University School of MedicineVarian Medical SystemsRecruitingNon-small Cell Lung Cancer | Early Stage Non-small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
AstraZenecaRecruitingUnresectable /Inoperable Locally Advanced (Stage II-III) Non-small Cells Lung Cancer (NSCLC)Russian Federation
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
Clinical Trials on hypofractionated radiation therapy
-
University of UtahNational Cancer Institute (NCI)RecruitingCervical Carcinoma | Endometrial CarcinomaUnited States
-
Changhai HospitalRecruitingLocalized Prostate CancerChina
-
University of UtahActive, not recruitingStage 0 Breast Cancer | Stage I Breast Cancer | Stage II Breast Cancer | Invasive Breast Carcinoma | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Ductal Breast Carcinoma In SituUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Prognostic Stage I Breast Cancer AJCC v8 | Prognostic Stage IA Breast Cancer AJCC v8 | Prognostic Stage IB Breast Cancer AJCC v8 | Prognostic Stage IIA Breast Cancer AJCC...United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8United States
-
University of Colorado, DenverActive, not recruitingBreast CancerUnited States
-
Samsung Medical CenterRecruitingRadiotherapy Side EffectKorea, Republic of
-
Postgraduate Institute of Medical Education and...Completed
-
Cancer Trials IrelandCompleted
-
Changhai HospitalRecruiting