Predicting Cell Death by Radiation Therapy in Early Stage Non-small Cell Lung Cancer: a Prospective Translational Trial

Early Stage Non-small Cell Lung Cancer Clinical Trial

— PEARL-1  

Official title:

Pathologic Effects of Neoadjuvant Radiation Therapy in Operable Early Stage Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01138722
• Other study ID #: 2010/204
• Secondary ID: LONG 10-01
• Status: Terminated
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: August 2011

Study information

• Verified date: July 2021
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 relationship between blood and tissue biomarkers, bio-imaging and pathology in patients with early stage NSCLC treated with hypofractionated radiation therapy and surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Proof of cT1a/b - 2a/b N0M0 NSCLC

• Informed Consent signed

• Resectable tumour

• Operable patient

• > 18 years old

• men and women

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Early Stage Non-small Cell Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• hypofractionated radiation therapy followed by surgery
hypofractionated radiation therapy followed by surgery

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Antwerp
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Nationaal Kankerplan

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological effects of hypofractionated radiation therapy	To describe the pathological effects of hypofractionated radioation therapy (RT) and to address the relationship with blood and tissue biomarkers and bio-imaging.	at 2 years
Secondary	clinical response rate		from 2 to 5 years
Secondary	the accuracy of clinical mediastinal staging		from 2 to 5 years
Secondary	the complication rate		from 2 to 5 years
Secondary	local, regional or distant failure		from 2 to 5 years
Secondary	progression free survival		from 2 to 5 years
Secondary	disease specific overall survival		from 2 to 5 years
Secondary	overall survival		from 2 to 5 years

External Links

•   website of University Hospital Ghent