Pathologic Effects of Neoadjuvant Radiation Therapy in Operable Early Stage Lung Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- University Hospital, Ghent
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- pathological effects of hypofractionated radiation therapy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
pathological effects of hypofractionated radiation therapy
Time Frame: 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 Outcomes
- clinical response rate(from 2 to 5 years)
- progression free survival(from 2 to 5 years)
- overall survival(from 2 to 5 years)
- the accuracy of clinical mediastinal staging(from 2 to 5 years)
- the complication rate(from 2 to 5 years)
- local, regional or distant failure(from 2 to 5 years)
- disease specific overall survival(from 2 to 5 years)