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

NCT02488850 | Completed

• 1 other identifier: NL42081.078.12
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

immune monitoring; T cell activation; early stage

Outcome Measures

Primary Outcomes (5)

• Number of IFN-gamma/ Granzyme B producing CD8 T cells

  Number and activation status of peripheral CD8+ T cells

  Baseline (week 0)

• Number of IFN-gamma/ Granzyme B producing CD8 T cells

  Number and activation status of peripheral CD8+ T cells

  Week 1

• Number of IFN-gamma/ Granzyme B producing CD8 T cells

  Number and activation status of peripheral CD8+ T cells

  Week 2

• Number of IFN-gamma/ Granzyme B producing CD8 T cells

  Number and activation status of peripheral CD8+ T cells

  Week 3

• Number of IFN-gamma/ Granzyme B producing CD8 T cells

  Number and activation status of peripheral CD8+ T cells

  Week 6

Secondary Outcomes (15)

• CD4/CD8 ratio in peripheral blood

  Baseline

• CD4/CD8 ratio in peripheral blood

  Week 1

• CD4/CD8 ratio in peripheral blood

  Week 2

• CD4/CD8 ratio in peripheral blood

  Week 3

• CD4/CD8 ratio in peripheral blood

  Week 6

Study Arms (2)

Surgery

ACTIVE COMPARATOR

An anatomical surgical resection of primary tumor

Procedure: Surgery

Radiotherapy

ACTIVE COMPARATOR

Stereotactic Ablative Radiotherapy (SABR), outpatient treatment that is typically delivered in between 3-8 fractions

Radiation: SABR

Interventions

Surgery PROCEDURE

Surgery

SABR RADIATION

Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cytologically or histologically proven cT1-2aN0M0 NSCLC
• Patients ≥ 18 years old
• Patients should be fit to undergo both treatments in accordance with institutional protocols

You may not qualify if:

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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (3)

Erasmus MC Cancer Institute

Rotterdam, South Holland, 3015GD, Netherlands

Location

Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands

Location

VU Medical Center

Amsterdam, Netherlands

Location

Related Publications (1)

• de Goeje PL, Smit EF, Waasdorp C, Schram MTB, Kaijen-Lambers MEH, Bezemer K, de Mol M, Hartemink KJ, Nuyttens JJME, Maat APWM, Hegmans JPJJ, Hendriks RW, Senan S, Aerts JGJV. Stereotactic Ablative Radiotherapy Induces Peripheral T-Cell Activation in Patients with Early-Stage Lung Cancer. Am J Respir Crit Care Med. 2017 Nov 1;196(9):1224-1227. doi: 10.1164/rccm.201610-2178LE. No abstract available.

  PMID: 28345951 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 2, 2015
• Study Start: December 1, 2012
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

NL (3)