Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC

NCT03742687 | Recruiting DMC

• 1 other identifier: HERAN
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Locally advanced NSCLC; Radiotherapy; Hypofractionation

Outcome Measures

Primary Outcomes (1)

• Overall survival

  One year overall survival rate calculated from raditherapy start day

  12 months

Secondary Outcomes (3)

• Time to locoregional failure

  60 months

• Incidence of acute toxicity

  6 months

• Incidence of late toxicity

  60 months

Study Arms (2)

A:Large target volume

EXPERIMENTAL

The target volume for radiotherapy treatment volume is considered too large for a standard treatment of 66Gy in 33 fractions, considering the expected normal tissue toxicity with a standard treatment plan. Heterogeneously Hypofractionated Radiotherapy plan ( 24 fractions )

Radiation: Heterogeneously Hypofractionated Radiotherapy

B:Fragile patient

EXPERIMENTAL

The patient is too fragile for standard long-course radiotherapy with 66 Gy. Heterogeneously Hypofractionated Radiotherapy plan ( 24 fractions )

Radiation: Heterogeneously Hypofractionated Radiotherapy

Interventions

Heterogeneously Hypofractionated Radiotherapy RADIATION

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.

A:Large target volume; B:Fragile patient

Eligibility Criteria

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

You may qualify if:

• Histologically or cytological confirmed locally advanced, inoperable NSCLC.
• Age ≥18 years.
• Signed informed consent.
• Performance status 0-2.
• Able to comply with study and follow-up procedures.
• Fertile women must have a negative pregnancy test. Fertile men and women must use effective contraception. Fertile women included in the study must use the pill, spiral, depot injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch for the duration of study treatment and one month thereafter.

You may not qualify if:

• Prior radiotherapy to the thorax, unless there is no significant overlap of current treatment volumes with previous treatment fields.
• Dose plan conforming to protocol planning criteria not possible.
• Uncontrolled metastatic disease.
• Other active malignant disease.

Sponsors & Collaborators

• Danish Lung Cancer Group: lead
• Odense University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Vejle Hospital: collaborator
• Herlev Hospital: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Radiation Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Azza A Khalil, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azza A Khalil, MD, PhD

CONTACT

+4578462556; azzakhal@rm.dk

Marianne M Knap, MD, PhD

CONTACT

+4578462556; mariknap@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Team leder, Consulant, MD, PhD

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: November 15, 2018
• Study Start: November 22, 2018
• Primary Completion: December 30, 2023
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

DK (1)