Determination of Peripheral Immune Cell Activity During Treatment With Either Surgery or Radiotherapy in Patients With Early Stage NSCLC

Non-small Cell Lung Cancer Clinical Trial

— HAMLET  

Official title:

Determination of Peripheral Immune Cell Activity During Treatment With Either Surgery or Radiotherapy in Patients With Early Stage Non-small Cell Lung Cancer HAMLET Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02488850
• Other study ID #: NL42081.078.12
• Status: Recruiting
• Phase: N/A
• Start date: December 2012

Study information

• Verified date: February 2023
• Source: Erasmus Medical Center
• Contact: Joachim G Aerts, MD, PhD
• Phone: +31 10 70 43697
• Email: j.aerts[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rationale: An anatomical surgical resection is considered to be the standard of care in fit patients who present with early stage non-small cell lung cancer (NSCLC). However, surgery is less frequently performed in both elderly patients (aged ≥75 years), who represent the fastest-growing group of patients with stage I/II NSCLC, and in patients who have significant co-morbidity. Following the introduction of stereotactic ablative radiotherapy (SABR), an outpatient treatment that is typically delivered in between 3-8 fractions, the median survival of all elderly patients undergoing radiotherapy in The Netherlands increased by 9.3 months. Randomized trials comparing SABR and surgery have yet to be completed and results of the ongoing ACOSOG Z4032 studies will not be available in the within 5 years. A recent data retrospective study comparing both modalities has raised interesting questions about the impact of local therapy on recurrence patterns. It was found that a better loco-regional disease control rate was achieved with SABR.

Objective: To study the effect of surgery and SABR on both immunostimulatory (with primary endpoint CD8 positive cells) and immunosuppressive cells in peripheral blood in patients with early stage non-small cell lung cancer who are treated with either modality.

Study population: 40 patients with cT1-2aN0M0 either cytologically or histologically proven NSCLC.

Main study parameters/endpoints: To determine whether an increase in CD8 activity can be established after SABR in patients with early stage lung cancer and to compare this increase with that in patients undergoing a surgical intervention. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Only risks in participation are the risks with drawing blood. Subjects will not have any benefits. This pilot study will be used to generate information concerning both treatments useful for the decision to plan a future study in a larger series of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cytologically or histologically proven cT1-2aN0M0 NSCLC

• Patients = 18 years old

• Patients should be fit to undergo both treatments in accordance with institutional protocols

Exclusion Criteria:

• Patients with any signs of any co-existing infectious disease or immunosuppressive treatment (inhalation steroids are permitted)

• Mentally incapacitated subjects

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Surgery

Radiation:
• SABR

Locations

Country	Name	City	State
Netherlands	Antoni van Leeuwenhoek Hospital	Amsterdam
Netherlands	VU Medical Center	Amsterdam
Netherlands	Erasmus MC Cancer Institute	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of IFN-gamma/ Granzyme B producing CD8 T cells	Number and activation status of peripheral CD8+ T cells	Baseline (week 0)
Primary	Number of IFN-gamma/ Granzyme B producing CD8 T cells	Number and activation status of peripheral CD8+ T cells	Week 1
Primary	Number of IFN-gamma/ Granzyme B producing CD8 T cells	Number and activation status of peripheral CD8+ T cells	Week 2
Primary	Number of IFN-gamma/ Granzyme B producing CD8 T cells	Number and activation status of peripheral CD8+ T cells	Week 3
Primary	Number of IFN-gamma/ Granzyme B producing CD8 T cells	Number and activation status of peripheral CD8+ T cells	Week 6
Secondary	CD4/CD8 ratio in peripheral blood		Baseline
Secondary	CD4/CD8 ratio in peripheral blood		Week 1
Secondary	CD4/CD8 ratio in peripheral blood		Week 2
Secondary	CD4/CD8 ratio in peripheral blood		Week 3
Secondary	CD4/CD8 ratio in peripheral blood		Week 6
Secondary	number of regulatory T cells		Baseline
Secondary	number of regulatory T cells		Week 1
Secondary	number of regulatory T cells		Week 2
Secondary	number of regulatory T cells		Week 3
Secondary	number of regulatory T cells		Week 6
Secondary	Activation marker expression on T cells		Baseline
Secondary	Activation marker expression on T cells		Week 1
Secondary	Activation marker expression on T cells		Week 2
Secondary	Activation marker expression on T cells		Week 3
Secondary	Activation marker expression on T cells		Week 6