NCT01836692

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

2.5 years

First QC Date

April 12, 2013

Last Update Submit

October 29, 2018

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (4)

  • The number of participants from the study population who are suitable to receive isotoxic IMRT treatment.

    12 months

  • The number of participants treated with isotoxic IMRT who experience grade 3+ pulmonary toxicity

    12 months

  • The number of participants treated with isotoxic IMRT who experience acute grade 3+ non haematological toxicity & other late toxicities

    12 months

  • Number of participants whose disease is controlled locally & overall survival rates

    Follow up visits every 4 months for 2 years & then 6 monthly for up to 5 years

Study Arms (1)

Thoracic radiotherapy

EXPERIMENTAL

Intensity Modulated Radiotherapy treatment (delivered twice daily on consecutive weekdays over 4.5 weeks)

Radiation: Intensity Modulated Radiotherapy treatment

Interventions

Intensity Modulated Radiotherapy treatmentRADIATION

Intensity Modulated Radiotherapy treatment

Thoracic radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Patients suitable for standard concurrent CTRT
  • Patients only suitable for radical RT due to PS and co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Belfast Health & Social Care NHS Trust - Northern Ireland Cancer Centre

Belfast, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

Cambridge, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust - St James's University Hospital

Leeds, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

Sheffield, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

Surrey, United Kingdom

Location

Related Publications (1)

  • Haslett K, Franks K, Hanna GG, Harden S, Hatton M, Harrow S, McDonald F, Ashcroft L, Falk S, Groom N, Harris C, McCloskey P, Whitehurst P, Bayman N, Faivre-Finn C. Protocol for the isotoxic intensity modulated radiotherapy (IMRT) in stage III non-small cell lung cancer (NSCLC): a feasibility study. BMJ Open. 2016 Apr 15;6(4):e010457. doi: 10.1136/bmjopen-2015-010457.

    PMID: 27084277DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Corinne Faivre-Finn, MD PhD

    The Christie NHS Foundation Trust

    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
SPONSOR INVESTIGATOR
PI Title
Prof Corinne Faivre-Finn, Consultant Clinical Oncologist

Study Record Dates

First Submitted

April 12, 2013

First Posted

April 22, 2013

Study Start

April 1, 2014

Primary Completion

October 1, 2016

Study Completion

June 1, 2018

Last Updated

October 31, 2018

Record last verified: 2018-10

Locations

GB(7)