A Phase 2 interventional study of WT_vDIBH and VMAT_FB in Breast Cancer, sponsored by Royal Marsden NHS Foundation Trust. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-19.
Sponsored by Royal Marsden NHS Foundation Trust · Phase 2, Interventional, and Treatment
This study aims to compare the resource impact, acute toxicity and feasibility of different pan-lymph node radiotherapy techniques. Radiotherapy using wide tangents with the patient in breath hold will be compared against volumetric modulated arc therapy (VMAT) in free breathing in the main trial. A parallel study will asses the accuracy of VMAT treatments using voluntary deep inspiratory breath hold compared to an active breathing controlled breath hold device.
Following publication of results of two large randomised clinical trials, pan-lymph node radiotherapy (pan-LN RT) (including treatment of the internal mammary chain) is set to become standard treatment in patients with lymph-node positive breast cancer. Traditional pan-LN RT techniques deliver high radiation doses to the heart and lungs which can cause long-term side-effects in women many years after their treatment. Modern techniques including breath-holding and volumetric-modulated arc therapy (VMAT) can reduce doses to heart and lungs but the investigators do not yet know which technique(s) are best in terms of resource costs, short to medium-term side-effects, and day to day accuracy. This study will compare the time taken to deliver pan-LN RT using breath-holding versus VMAT and will collect side-effect data up to one year following treatment as well as modelling long-term cardiac risks based on heart doses delivered. The results of the main study will help guide clinicians and departments in selecting the best pan-LN RT techniques for their patients. A parallel study will evaluate the combination of breath-hold and VMAT using a machine-based technique called the active-breathing controlled (ABC) device against a more simple voluntary breath-hold technique were patients simply take a breath in and hold it for up to 20 seconds at a time. These techniques will be compared in terms of their day-to-day accuracy. If the simpler technique proves as accurate as the ABC-technique, this will establish the simpler technique as a less resource-intensive standard of care adoptable by other radiotherapy departments.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 39 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Royal Marsden NHS Foundation Trust is the lead sponsor of 272 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
Wide tangent radiotherapy in voluntary deep inspiratory breath hold
Radiation: WT_vDIBH
Volumetric modulated arc therapy in free breathing.
Radiation: VMAT_FB
Linear Accelerator time
Patient mounting couch to linear accelerator being turned off
Time frame: 3 weeks
Acute toxicity - Skin
CTCAE grading
Time frame: 5 weeks
Acute toxicity - lung (pneumonitis)
CTCAE grading
Time frame: 5 weeks
Acute toxicity - oesophagitis
CTCAE grading
Time frame: 5 weeks
Acute toxicity - fatigue
EORTC QLQ-C30 + FA13
Time frame: 5 weeks
Acute toxicity - quality of life
EORTC QLQ-C30 + BR23
Time frame: 5 weeks
Intermediate toxicity - lung (pneumonitis)
CTCAE pneumonitis assesment
Time frame: up to 1 year
Intermediate toxicity - fatigue
EORTC QLQ-C30 + FA13
Time frame: up to 1 year
Intermediate toxicity - quality of life
EORTC QLQ-C30
Time frame: up to 1 year
Intermediate toxicity - lymphoedema/ shoulder dysfunction
EORTC BR23
Time frame: up to 1 year
Organ at risk dose - ipsilateral lung
mean dose to the ipsilateral lung (Gy) measured using DVH
Time frame: Immediate
Organ at risk dose - contralateral lung
mean dose to the contralateral lung (Gy) measured using DVH
Time frame: Immediate
Organ at risk dose - heart
mean dose to the heart (Gy) measured using DVH
Time frame: Immediate
Organ at risk dose - contralateral breast
mean dose to the contralateral breast (Gy) measured using DVH
Time frame: Immediate
Organ at risk dose - thyroid
mean dose to the thyroid (Gy) measured using DVH
Time frame: Immediate
Organ at risk dose - humeral head
mean dose to the humeral head (Gy) measured using DVH
Time frame: Immediate
Organ at risk dose - brachial plexus
maximum dose to the brachial plexus (Gy) measured using DVH
Time frame: Immediate
Organ at risk dose - Left anterior descending coronary artery
maximum dose to the Left anterior descending coronary artery (Gy) measured using DVH
Time frame: Immediate
Organ at risk dose - oesophagus
maximum dose to the oesophagus (Gy) measured using DVH
Time frame: Immediate
Time taken to plan and check radiotherapy
Time frame: Immediate
Inter-fraction reproducibility
Distance - shift from planning CT on CBCT (mm)
Time frame: 3 weeks
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
Ran from Dec 2016 to primary completion in Jan 2019, 25 months.
Of 983 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 85. This study's 25 months is below that.
Counting every sponsor, half of 1,201 studies reached it within 49 months; a quarter within 31 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Royal Marsden NHS Foundation Trust →