PEARL-1: Predicting Cell Death by Radiation Therapy in Early Stage Non-small Cell Lung Cancer: a Prospective Translational Trial

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01138722
• Collaborator: Nationaal Kankerplan (Other)
• Enrollment: 1
• Locations: 2
• Duration (Months): 15
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Early Stage Non-small Cell Lung Cancer	Radiation: hypofractionated radiation therapy followed by surgery	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pathologic Effects of Neoadjuvant Radiation Therapy in Operable Early Stage Lung Cancer
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Outcome Measures

Primary Outcome Measures

1. pathological effects of hypofractionated radiation therapy [at 2 years]

   To describe the pathological effects of hypofractionated radioation therapy (RT) and to address the relationship with blood and tissue biomarkers and bio-imaging.

Secondary Outcome Measures

1. clinical response rate [from 2 to 5 years]

2. the accuracy of clinical mediastinal staging [from 2 to 5 years]

3. the complication rate [from 2 to 5 years]

4. local, regional or distant failure [from 2 to 5 years]

5. progression free survival [from 2 to 5 years]

6. disease specific overall survival [from 2 to 5 years]

7. overall survival [from 2 to 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Proof of cT1a/b - 2a/b N0M0 NSCLC

• Informed Consent signed

• Resectable tumour

• Operable patient

• 18 years old

• men and women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Antwerp	Antwerp		Belgium
2	University Hospital Ghent	Ghent		Belgium

Sponsors and Collaborators

• University Hospital, Ghent
• Nationaal Kankerplan

Investigators

• Principal Investigator: Jan Van Meerbeeck, MD, PhD, University Hospital Ghent, Belgium

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• website of University Hospital Ghent

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT01138722
• Other Study ID Numbers: 2010/204; LONG 10-01
• First Posted: Jun 7, 2010
• Last Update Posted: Jul 8, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by University Hospital, Ghent: early stage non-small cell lung cancer; hypofractionated radiation therapy
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jul 8, 2021