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Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC

NCT03742687 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2023-09-11

No results posted yet for this study

Summary

The options for patients with locally advanced non-small cell lung cancer (NSCLC) who are not candidates for a standard definitive chemoradiotherapy regime are meagre. These are patients who are not fit for a chemoradiotherapy schedule of 66 Gy in 2 Gy fractions due to either tumour extent, resulting in excessive dose to the healthy tissue in the thorax, or with performance status not supporting seven weeks of intensive treatment.

The aim is to study the efficiency as well as the safety of a new treatment option of heterogeneously hypofractionated radiotherapy for patients with locally advanced NSCLC who are not candidates for standard, high-dose chemoradiotherapy, either due to excessive irradiation of normal tissue (defined as category A patients) or due to fragility of the patient (category B patients).

Conditions

  • Stage III Non-small-cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Radiotherapy Side Effect

Interventions

RADIATION

Heterogeneously Hypofractionated Radiotherapy

A heterogeneous hypofractionated schedule for the treatment of high-risk locally advanced NSCLC patients in which the central idea is to decrease dose to normal tissue by ascribing a heterogeneous dose to the PTV. The dose to the periphery of the PTV as well as to the majority of lymph node targets is decreased compared to a standard treatment. The gross volume of the primary tumour and bulky lymph nodes receive mean doses of up to 66 Gy in 24 fractions, and thus receive a hypofractionated higher biological effective dose than standard 66 Gy in 33 fractions.

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Vejle Hospital

    collaborator OTHER

  • Herlev Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Danish Lung Cancer Group

    lead OTHER

Principal Investigators

  • Azza A Khalil, MD, PhD · Aarhus University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-22
Primary Completion
2023-12-30
Completion
2026-12-30

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 NCT03742687 on ClinicalTrials.gov