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Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study


N/A
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study


Background:

Approximately 12,000 patients are diagnosed with stage III NSCLC in the UK each year and
their survival is ~15% at 5 years. As the majority of patients are not suitable for the gold
standard treatment (concurrent chemo-radiotherapy (CTRT), novel strategies integrating
radiotherapy (RT) technological advances and radiobiological knowledge need to be evaluated
in patients treated with the alternative treatment option, sequential CTRT. There is solid
evidence that improving local control in lung cancer leads to increased survival. Strategies
to improve local control in stage III NSCLC include dose escalation and individualisation
which are limited by the dose delivered to surrounding normal tissues. We hypothesise that
this will be facilitated by the use of IMRT.

Objectives:

To demonstrate the feasibility of delivering isotoxic RT using IMRT and hyperfractionated
accelerated RT in stage III NSCLC patients who are not suitable for concurrent CTRT.

Endpoints:

Primary endpoint: Delivery of isotoxic IMRT to dose >60 Gy EQD2 (total biologically
equivalent in 2 Gy fraction).

Secondary endpoints: Estimation of the suitability for lung isotoxic IMRT, estimation of
proportion of patients with acute grade 3+ non haematological toxicity, estimation of late
toxicity, estimation of local control/overall survival and development of a robust Quality
Assurance (QA) process for lung IMRT.

Design:

Prospective multicentre, non-randomised feasibility study with early stopping rules.

35 patients will be recruited in this prospective multicentre feasibility study. Stopping
rules are in place to ensure the safety of patients. We estimate that this regimen would be
of added value to a national randomised phase II trial if 80% of the patients can be planned
to a dose >60 Gy EQD2.

Intervention:

Patients with stage III NSCLC, PS 0-2, not suitable for concurrent CTRT, will be treated
with individualised doses of radiation based on pre-specified normal tissue doses (spinal
cord, brachial plexus, lung tissue, heart and great vessels/proximal bronchial tree).
Radiotherapy will be delivered twice-daily over a maximum period of 4.5 weeks using IMRT and
the dose of radiation will be increased until one or more of the organs at risk tolerance or
the maximum dose of 79.2 Gy is reached.


Inclusion Criteria:



- Histologically or cytologically confirmed NSCLC

- Inoperable Stage III disease (T3N1-3, any T4, any N2 -3) confirmed by PET scanning,
mediastinoscopy or thoracoscopy

- Patients treated with at least 2 cycles of platinum based induction chemotherapy and
able to start radiotherapy within 5 weeks of the last cycle of chemotherapy

- Tumour judged inoperable by a lung MDT

- Age 18+, no upper age limit

- Performance status (PS) - ECOG 0-2. Patients with PS 2 whose general condition is
explained by disease can be included at the discretion of the local investigator.
Patients with PS 2 as a result of co-morbid conditions will be excluded

- Patient considered suitable for radical RT

- Tumour that can be encompassed within a radical RT treatment volume (MLD expected to
be <20Gy)

Exclusion Criteria:

- Patients suitable for standard concurrent CTRT

- Patients only suitable for radical RT due to PS and co-morbidities

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The number of participants treated with isotoxic RT (to dose >60 Gy EQD2) using IMRT & hyperfractionated accelerated RT.

Outcome Description:

Radiotherapy treatment plans & OAR tolerance doses will be analysed to assess the feasibility of delivering the proposed treatment.

Outcome Time Frame:

Stage 1 (12 months) - after 19 patients have been treated with isotoxic IMRT

Safety Issue:

No

Principal Investigator

Corinne Faivre-Finn, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Christie Hospital NHS Foundation Trust

Authority:

United Kingdom: Research Ethics Committee

Study ID:

11_DOG07_136

NCT ID:

NCT01836692

Start Date:

October 2013

Completion Date:

October 2020

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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