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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Christie Hospital NHS Foundation Trust
Sponsor:
Collaborators:
Cancer Research UK
British Lung Foundation
Sheffield Teaching Hospitals NHS Foundation Trust
Belfast Health and Social Care Trust
The Leeds Teaching Hospitals NHS Trust
Cambridge University Hospitals NHS Foundation Trust
Royal Marsden NHS Foundation Trust
East and North Hertfordshire NHS Trust
Information provided by (Responsible Party):
Sally Falk, Christie Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01836692
First received: April 12, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

This study is for patients having a course of chest radiotherapy treatment after receiving chemotherapy for the treatment of non-small cell lung cancer. Patients with non-small cell lung cancer have a risk of the tumour in the lung recurring or progressing after treatment.

In this study, we will investigate:

  • whether giving a more targeted and individualised type of chest irradiation or radiotherapy to the lung tumour (known as Isotoxic IMRT), is practical and whether it causes side effects which can be tolerated
  • whether this new method of delivering the radiotherapy can reduce the risk of the tumour in the lung recurring or progressing
  • whether survival can be improved by using this new radiotherapy method

The dose of chest irradiation will be calculated specifically to suit patient's body shape, the position of the lung cancer, and how close healthy tissues are to the tumour. Radiotherapy will be delivered twice a day over a maximum period of 4.5 weeks. The duration of treatment will vary individually according to the delivered dose to the tumour area.


Condition Intervention
Non Small Cell Lung Cancer
Radiation: Intensity Modulated Radiotherapy treatment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study

Resource links provided by NLM:


Further study details as provided by Christie Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • The number of participants treated with isotoxic RT (to dose >60 Gy EQD2) using IMRT & hyperfractionated accelerated RT. [ Time Frame: Stage 1 (12 months) - after 19 patients have been treated with isotoxic IMRT ] [ Designated as safety issue: No ]
    Radiotherapy treatment plans & OAR tolerance doses will be analysed to assess the feasibility of delivering the proposed treatment.


Secondary Outcome Measures:
  • The number of participants from the study population who are suitable to receive isotoxic IMRT treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Stage 1 - if 13/19 patients can be planned to a dose of >60 Gy EQD2 the study will proceed to stage 2 and recruit a further 16 patients. Assessed via RT planning data.

  • The number of participants treated with isotoxic IMRT who experience grade 3+ pulmonary toxicity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Stage 1 - if <3/19 participants experience grade 3+ acute pulmonary toxicity the study will proceed to stage 2 and recruit a further 16 patients. Assessed via toxicity data.

  • The number of participants treated with isotoxic IMRT who experience acute grade 3+ non haematological toxicity & other late toxicities [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To assess via toxicity data, the number of patients who experience grade 3+ non haematological toxicities and other late toxicities

  • Number of participants whose disease is controlled locally & overall survival rates [ Time Frame: Follow up visits every 4 months for 2 years & then 6 monthly for up to 5 years ] [ Designated as safety issue: No ]
    After completion of radiotherapy treatment regular follow up will continue and data on long term toxicity, local control and survival will be collected.


Estimated Enrollment: 35
Study Start Date: April 2014
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thoracic radiotherapy
Intensity Modulated Radiotherapy treatment (delivered twice daily on consecutive weekdays over 4.5 weeks)
Radiation: Intensity Modulated Radiotherapy treatment
Intensity Modulated Radiotherapy treatment

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836692

Contacts
Contact: Corinne Faivre-Finn, MD PhD 0044 161 446 8200 corinne.finn@christie.nhs.uk
Contact: Sally Falk 0044 161 918 7101 sally.falk@christie.nhs.uk

Locations
United Kingdom
Belfast Health & Social Care NHS Trust - Northern Ireland Cancer Centre Not yet recruiting
Belfast, United Kingdom
Principal Investigator: Gerard Hanna         
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital Not yet recruiting
Cambridge, United Kingdom
Principal Investigator: Susan Harden         
Beatson West of Scotland Cancer Centre Not yet recruiting
Glasgow, United Kingdom
Principal Investigator: Stephen Harrow         
Leeds Teaching Hospitals NHS Trust - St James's University Hospital Not yet recruiting
Leeds, United Kingdom
Principal Investigator: Kevin Franks         
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom
Principal Investigator: Corinne Faivre-Finn, MD PhD         
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital Not yet recruiting
Sheffield, United Kingdom
Principal Investigator: Matthew Hatton         
The Royal Marsden NHS Foundation Trust Not yet recruiting
Surrey, United Kingdom
Principal Investigator: Fiona McDonald         
Sponsors and Collaborators
Sally Falk
Cancer Research UK
British Lung Foundation
Sheffield Teaching Hospitals NHS Foundation Trust
Belfast Health and Social Care Trust
The Leeds Teaching Hospitals NHS Trust
Cambridge University Hospitals NHS Foundation Trust
Royal Marsden NHS Foundation Trust
East and North Hertfordshire NHS Trust
Investigators
Principal Investigator: Corinne Faivre-Finn, MD PhD Christie Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Sally Falk, Dr Corinne Faivre-Finn, Consultant Clinical Oncologist, Christie Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01836692     History of Changes
Other Study ID Numbers: 11_DOG07_136
Study First Received: April 12, 2013
Last Updated: April 2, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014