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Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer (SARON)

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ClinicalTrials.gov Identifier: NCT02417662
Recruitment Status : Recruiting
First Posted : April 16, 2015
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University College, London

Brief Summary:
The trial will assess the addition of stereotactic ablative radiotherapy (SABR) to standard chemotherapy in patients with oligometastatic non-small cell lung cancer. Patients will be randomised to receive either standard treatment alone (platinum-based doublet chemotherapy) or standard treatment with conventional radiotherapy (RT) and SABR.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Radiation: Radical Radiotherapy (Conventional RT and SABR) Other: Non-investigational platinum-based doublet chemotherapy Not Applicable

Detailed Description:

SARON is a confirmatory phase III study examining the efficacy and safety of stereotactic ablative radiotherapy (SABR) and conventional radiotherapy (RT) alongside standard chemotherapy in patients with oligometastatic non-small cell lung cancer.

Current treatment for this group of patients is platinum-based doublet chemotherapy alone. There is sufficient evidence regarding the safety of SABR, its effect on local control and a possible impact on overall survival. This trial will further examine overall survival, progression free survival and local control, as well as toxicity, feasibility, patient reported outcomes and health resource use.

There will be a feasibility analysis performed after 50 patients have been randomised. This will assess the practicality of achieving recruitment targets, logistics of delivering the experimental treatment and the potential for contamination (as patients may seek SABR outside of the trial if randomised to the non SABR arm). There will also be a parallel thoracic SABR safety and feasibility study after recruitment and treatment of 20 patients with thoracic metastases.

This is a multicentre randomised phase III study based on patients with oligometastatic NSCLC.

Trial arms:

Control Arm: standard treatment alone (platinum-based doublet chemotherapy) Experimental Arm: standard treatment plus radical RT to primary and SABR and/or SRS to metastases


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer. A Randomised Phase III Trial
Study Start Date : August 2016
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Chemotherapy alone
Standard platinum-based doublet chemotherapy
Other: Non-investigational platinum-based doublet chemotherapy
There is no intervention in the control group, patients will receive standard chemotherapy alone.

Experimental: Chemotherapy + Radical Radiotherapy (Conventional RT and SABR)
Standard platinum-based doublet chemotherapy followed by radical RT (conventional or SABR) to the primary and SABR to the metastatic sites
Radiation: Radical Radiotherapy (Conventional RT and SABR)
Radical radiotherapy (conventional or SABR) to primary and SABR to the metastases




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From date of first chemotherapy treatment to the date of death, up to 36 months ]
    The trial will investigate the impact of the addition of radical conventional and stereotactic radiotherapy to standard systemic therapy on overall survival


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Time from first chemotherapy until progression or death, up to 36 months. ]
    The trial will investigate the impact of the addition of radical conventional and stereotactic radiotherapy to standard systemic therapy on progression free survival

  2. Toxicity (radiotherapy related toxicity Adverse events) [ Time Frame: From registration to up to 36 months after the first patient is randomised ]
    Safety analyses will be performed on all patients who received at least one dose of chemotherapy or fraction of SRT post-randomisation. Radiotherapy-related toxicity and early and late toxicity will be investigated. Adverse events will be compared between the two groups, as well as dose delays, reductions and compliance to chemotherapy and radiotherapy.

  3. Local Tumour Control by assessment of tumours at baseline and at progression according to RECIST v1.1 [ Time Frame: From time of randomisation to time of progression or death, up to 36 months ]
    The trial will investigate the impact of the addition of radical conventional and stereotactic radiotherapy to standard systemic therapy on local tumour control

  4. Health Related Quality of Life using the EORTC-QLQ-C30 and EORTC-LC13 questionnaires [ Time Frame: From time of registration to time of death or up to 36 months ]
    The health related quality of life for each treatment arm will be assessed.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Histologically or cytologically confirmed NSCLC.
  2. Negative or unknown EGFR and ALK mutation (EGFR testing is mandatory and ALK testing to be performed if part of local policy).
  3. Staging with FDG PET-CT whole body scan and MRI brain or CT brain with IV contrast.
  4. Patient presenting with synchronous primary disease and oligometastatic disease.
  5. Patient is deemed fit to receive at least four cycles of platinum-based doublet chemotherapy, cisplatin or carboplatin, according to local guidelines and assessment.
  6. Patient is deemed fit to receive conventional RT and SABR/SRS according to local guidelines and assessment.
  7. Primary tumour suitable for radical RT (either conventional RT or SABR/SRS).
  8. Between one and three metastatic lesions, assessable according to RECIST v1.1 and suitable for SABR/SRS (only one site of metastases or primary tumour needs to be measurable according to RECIST v1.1). Note: If brain metastasis present, the largest lesion must be less than no more than 3cm in maximum diameter at the time of randomisation. The second lesion must be no more than 2cm.
  9. Acceptable lung function for radical lung radiotherapy.
  10. No relevant co-morbidities, including pulmonary fibrosis and connective tissue disorders.
  11. ECOG performance status 0 to 1 at time of registration (can be ECOG 0-2 at randomisation).

Exclusion criteria

  1. Patient has had palliative radiotherapy to any tumour site prior to registration and/or requires palliative radiotherapy prior to randomisation.
  2. Patient has received any previous treatment for this NSCLC malignancy.
  3. Patients who present with brain metastasis only and no sites of extra cranial metastatic disease i.e. the presence of more than 2 brain metastases is an exclusion criteria.
  4. Brain metastasis within the brainstem.
  5. Metastasis in sites where normal radiotherapy constraints cannot be met.
  6. Metastasis in a previously irradiated area
  7. Patients who had more than three sites of disease prior to trial registration.
  8. Primary tumour or metastases causing direct invasion or high clinical suspicion of direct invasion of the wall of any major blood vessel.
  9. Malignant pleural or pericardial effusion.
  10. Patients with bilateral adrenal metastases.
  11. Stage III disease even with extensive nodal disease.
  12. History of prior malignant tumour likely to interfere with the protocol treatment or comparisons, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer.
  13. Leptomeningeal disease.
  14. Women who are pregnant or breast feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417662


Contacts
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Contact: Kate Frost ctc.saron@ucl.ac.uk

Locations
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United Kingdom
Belfast City Hospital Recruiting
Belfast, United Kingdom
Principal Investigator: Gerry Dr Hanna         
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom
Contact: Qamar Dr Ghafoor         
Bristol Royal Infirmary Recruiting
Bristol, United Kingdom
Contact: Charles Dr Comins         
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom
Principal Investigator: Susan Dr Harden         
BEATSON Not yet recruiting
Glasgow, United Kingdom
Principal Investigator: Stephen Dr Harrow         
Royal Surrey County Hospital Recruiting
Guildford, United Kingdom
Principal Investigator: Veni Dr Erzhil         
St James's University Hospital Recruiting
Leeds, United Kingdom
Principal Investigator: Kevin Dr Frank         
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom
Principal Investigator: Thiagarajan Dr Sridhar         
Charing Cross Hospital Recruiting
London, United Kingdom
Principal Investigator: Danielle Dr Power         
Guy's and St Thomas's Hospital Recruiting
London, United Kingdom
Contact: Shahreen Dr Ahmad         
Mount Vernon Cancer Centre Recruiting
London, United Kingdom
Principal Investigator: Suzannah Dr Mawdsley         
St Bart's Hospital Recruiting
London, United Kingdom
Contact: John Dr Conibear         
The Royal Marsden Hospital Recruiting
London, United Kingdom
Principal Investigator: Merina Dr Ahmed         
Christie Hospital Recruiting
Manchester, United Kingdom
Principal Investigator: Corinne Dr Faivre-Finn         
The James Cook University Hospital Recruiting
Middlesbrough, United Kingdom
Contact: Clive Dr Peedell         
Freeman Hospital Recruiting
Newcastle, United Kingdom
Contact: Phillip Dr Atherton         
City Hospital Recruiting
Nottingham, United Kingdom
Principal Investigator: Karen Dr Foweraker         
Weston Park Hospital Recruiting
Sheffield, United Kingdom
Principal Investigator: Matthew Dr Hatton         
Southampton General Hospital Recruiting
Southampton, United Kingdom
Principal Investigator: Andrew Dr Bates         
Clatterbridge Cancer Centre Recruiting
Wirral, United Kingdom
Principal Investigator: Anthony Pope         
Sponsors and Collaborators
University College, London
Cancer Research UK
Investigators
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Principal Investigator: David Landau Guys & St Thomas NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02417662     History of Changes
Other Study ID Numbers: UCL/13/0594
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Keywords provided by University College, London:
NSCLC
Stereotactic Ablative Radiotherapy
Radiotherapy
Randomised
Controlled
Oligometastatic

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