State of the Art Photon Therapy Versus Particle Therapy for Small Lung Tumors; a Planning Study Based on a Reference Dataset of Patients

NCT02038413 | Completed

• 1 other identifier: ROCOCO Lung stage I
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Compared to conventional radiotherapy with photons (CRT), particle therapy (PT) has the potential to inflict maximum damage on tumors with minimum collateral damage to neighboring healthy tissue. Given that the cost of particle therapy (PT) is considerably higher than that of conventional radiotherapy (RT) with photons, it is necessary to establish whether these higher costs are worthwhile in light of the expected advantages. Thus, clear evidence of the situations in which PT outperforms conventional photon treatment is needed. In a previous ROCOCO study (lung stage I-IIIB) an inhomogeneous group of patients with regard to tumor stage and size was included1. Conformal radiotherapy and Intensity Modulated Radiotherapy were used in the comparison. In this study patients with smaller tumors are included (stage I). A stereotactic treatment schedule and more advanced treatment techniques, such as CyberKnife, RapidArc, IMRT and Tomotherapy, are eligible for these kind of lesions. As a result the comparison as demonstrated in our previous study maybe invalid. We propose to investigate to what extend proton and 12C-ion therapy decrease the amount of irradiated normal tissue compared to state of the art photon modalities in stage I lung cancer patients.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; cT1/cT2aN0M0; Stereotactic lung treatment; MAASTRO; age >18 years

Outcome Measures

Primary Outcomes (1)

• Radiation exposure for organs at risk (OAR) in a stereotactic lung radiotherapy treatment.

  A wide range of organs is included, to be able to document doses to organs that are further away from the target volume, and also to quantify low doses to organs. Included OAR's are; left lung, right lung, (part of the) ribs if less then 2 cm from the CTV, for non-apical tumors: liver, spinal canal resembling the spinal cord, esophagus (full length), trachea, and main bronchi up to the first bifurcation, skin (with a thickness of standardized 4 mm), thyroid area, heart, mediastinal great vessels (aorta, vena cava, main lung arteries, ...), portacath, pacemaker (or any other implanted device to be avoided), brachial plexus and stomach.

  1 year

Secondary Outcomes (1)

• The risk of side effects in the irradiated normal tissue

  1 year

Study Arms (1)

NSCLC stage I

Consecutive patients were identified from October 2009 onwards in MAASTRO clinic, Maastricht. All patients received respiratory gated CT (4DCT) scans. All were patients referred for primary radiotherapy or chemo radiation.

Eligibility Criteria

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

Study Population

The study population consists of 25 NSCLC patients; stages I (cT1/cT2aN0M0). Consecutive patients were identified from October 2009 onwards in MAASTRO clinic, Maastricht. All patients received respiratory gated CT (4DCT) scans. All were patients referred for primary radiotherapy or chemo radiation.

You may qualify if:

• \>18 years of age
• referred for primary radiotherapy or chemo radiation
• NSCLC stage I
• received respiratory gated CT (4DCT) scans

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• University of Pennsylvania: collaborator

Study Sites (1)

MAASTRO clinic

Maastricht, Limburg, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Philippe Lambin, MD, PhD

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

• Esther Troost, PhD

  Maastro Clinic, The Netherlands

  STUDY DIRECTOR

• Erik Roelofs

  Maastro Clinic, The Netherlands

  STUDY DIRECTOR

• Esther Bloemen

  Maastro Clinic, The Netherlands

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 16, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2016
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

NL (1)