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

NCT02540499 | Completed

• 1 other identifier: H-15000617
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lung cancer; breath hold; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Feasibility (more than 70% of advanced stage NSCLC patients can perform stable DIBH (4 to 6 sequential breath holds of ≥ 15 sec)

  1 month afte inclusion of last patient

Secondary Outcomes (3)

• Lung tissue density changes assessed from CT scans will be correlated to radiation-induced lung damage registered clinically

  1 year after inclusion of the last patient

• Number of patients with dosimetrically superior treatment plan in DIBH

  3 months after inclusion of the last patient

• Mean lung dose reduction in DIBH assessed from the radiotherapy treatment plan

  3 months after inclusion of the last patient

Study Arms (1)

DIBH VMAT

EXPERIMENTAL

Volumetric modulated arc radiotherapy in visually guided voluntary -deep inspiration breath-hold for patients with locally advanced NSCLC referred for concomitant radiotherapy 2 Gy x 33, 5 F/W and 3 courses of platinum based combination chemotherapy. Will be compared to a historic cohort of patients treated with VMAT in free breathing

Radiation: DIBH VMAT

Interventions

DIBH VMAT RADIATION

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

DIBH VMAT

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed non-small cell lung cancer (NSCLC)
• Referral and eligibility for concomitant or sequential radiotherapy
• Performance status ≤ 2
• Signed informed consent

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gitte F Persson, MD PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Staff specialist

Study Record Dates

• First Submitted: May 10, 2015
• First Posted: September 4, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

DK (1)