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Deep Inspiration Breath Hold as Primary Strategy for Locally Advanced Lung Cancer Radiotherapy

NCT02540499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-02-24

No results posted yet for this study

Summary

Despite considerable advances in cancer treatment, patients with locally advanced lung cancer still face a poor chance of survival and a high risk of experiencing serious, life threatening treatment-related side-effects. These side-effects are poorly understood and difficult to measure: it is therefore challenging to design new treatment strategies aiming to decrease treatment toxicity and yet increase survival. At present, many patients present with tumours so large that only a low palliative dose of radiation therapy can be offered in order to keep the risk of side-effects to an acceptable level. In this project, named INHALE, the possibility of irradiating lung cancer patients while they hold their breath in deep inspiration (so called: Deep inspiration breath hold, or DIBH) will be investigated. In DIBH, the healthy lung tissue is pushed away from the tumour, and even when a large tumour is present, a high curative dose of radiation therapy can be offered. This technique is simple and is widely used to treat breast cancer patients in our institution as well as in other centres in the world. If positive, results from INHALE can be transferred easily and with minimal costs throughout Denmark and the rest of the world.

DIBH has only sporadically been used in lung cancer patients to date, because of the assumption that this patient group, often having a poor performance status, could not comply with DIBH procedure. However, the investigators' experience has shown that the majority of lung cancer patients can comfortably hold short repeated DIBHs during treatment sessions throughout the eight weeks of their treatment course, even if they have a relatively poor lung function.

The differences in side-effects between patients treated with the INHALE regimen and a large group of patients previously treated at our institution will be thoroughly investigated, using both follow-up CT images and a range of clinical parameters. INHALE is a unique study because of combining use of the highest level of technology to ensure high-quality treatment in DIBH and a thorough scientific investigation of follow-up data. INHALE will provide an improved understanding of how to assess and decrease treatment side-effects: consequently the investigators aim to test the hypothesis in a large clinical trial in order to improve survival of lung cancer patients.

Conditions

  • Lung Neoplasms

Interventions

RADIATION

DIBH VMAT

Radiotherapy delivered in deep inspiration breath-hold with volumetric modulated arc therapy technique.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Gitte F Persson, MD PhD · Rigshospitalet, Denmark

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-12-31
Completion
2020-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02540499 on ClinicalTrials.gov