NCT02771353

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_2 breast-cancer

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 26, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

December 12, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

April 26, 2016

Last Update Submit

April 12, 2022

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Linear Accelerator time

    Patient mounting couch to linear accelerator being turned off

    3 weeks

Secondary Outcomes (20)

  • Acute toxicity - Skin

    5 weeks

  • Acute toxicity - lung (pneumonitis)

    5 weeks

  • Acute toxicity - oesophagitis

    5 weeks

  • Acute toxicity - fatigue

    5 weeks

  • Acute toxicity - quality of life

    5 weeks

  • +15 more secondary outcomes

Study Arms (2)

WT_vDIBH

ACTIVE COMPARATOR

Wide tangent radiotherapy in voluntary deep inspiratory breath hold

Radiation: WT_vDIBH

VMAT_FB

ACTIVE COMPARATOR

Volumetric modulated arc therapy in free breathing.

Radiation: VMAT_FB

Interventions

WT_vDIBHRADIATION
WT_vDIBH
VMAT_FBRADIATION
VMAT_FB

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • Female or male
  • Invasive carcinoma of the breast (left or right-sided)
  • Breast conservation surgery or mastectomy
  • Axillary staging and/or dissection
  • pT1-T4,N1-2,M0 disease
  • Histological involvement of axillary lymph nodes
  • Indication for radiotherapy to the IMC, axillary levels I-III and/or level IV
  • Patient able to tolerate breath hold
  • Performance status 0-1

You may not qualify if:

  • Contralateral and/or previous ipsilateral breast cancer, irrespective of date of diagnosis
  • Past medical history of malignancy except (i) basal cell skin carcinoma, (ii) CIN cervix uteri, (iii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free
  • Previous radiotherapy to any region above the diaphragm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2016

First Posted

May 13, 2016

Study Start

December 12, 2016

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share