Condition category
Cancer
Date applied
11/07/2006
Date assigned
28/07/2006
Last edited
12/07/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Prof John Yarnold

ORCID ID

Contact details

Institute of Cancer Research
Academic Radiotherapy Department
Royal Marsden NHS Trust
Downs Road
Sutton
SM2 5PT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00814567

Protocol/serial number

CCR2690

Study information

Scientific title

Acronym

IMPORT LOW

Study hypothesis

To test partial breast radiotherapy delivered using intensity modulated techniques following complete local tumour excision of low risk early stage breast cancer.

A related study IMPORT HIGH is registered with ISRCTN47437448.

Ethics approval

Oxford Research Ethics Committee B on 12/10/2006 (ref: 06/Q1605/128)

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Breast cancer

Intervention

This is a randomised controlled trial for patients at low risk of local recurrence (less than 1% annual risk local recurrence after radiotherapy).

Control group: current standard radiotherapy to the whole breast
Test arm one: reduced radiotherapy to the whole breast with standard radiotherapy to the partial breast
Test arm two: standard radiotherapy to the partial breast only

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Local tumour control in the ipsilateral breast

Secondary outcome measures

1. Location of tumour relapse
2. Contralateral primary tumours
3. Regional and distant metastases
4. Late adverse effects in normal tissues
5. Quality of life (QL)
6. Economic evaluation

Overall trial start date

01/03/2007

Overall trial end date

01/10/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age greater than or equal to 50 years
2. Primary breast conservation surgery +/- adjuvant systemic therapy
3. Pathological tumour size less than or equal to 2.0 cm pT1a-c (maximum microscopic diameter of invasive component)
4. Invasive adenocarcinoma (excluding invasive carcinoma of classical lobular type)
5. Unifocal disease (Grade I or II)
6. Minimum microscopic margin of non-cancerous tissue greater than or equal to 2 mm (excluding deep margin if this is at deep fascia)
7. No lympho-vascular invasion
8. Axillary lymph nodes negative, PN0 (sentinel node biopsy & isolated tumour cells less than 0.2 mm allowed)
9. No blood borne metastases

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1,935

Participant exclusion criteria

1. Previous malignancy (other than non-melanomatous skin cancer)
2. Mastectomy
3. Invasive carcinoma of classical lobular type
4. Primary endocrine therapy or chemotherapy (neo-adjuvant endocrine therapy is permissible as long as the tumour is less than 2.0 cm and all other inclusion criteria are met. Primary endocrine therapy as a replacement for surgery is not permissible)
5. Concurrent chemo-radiotherapy

Recruitment start date

01/03/2007

Recruitment end date

01/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Cancer Research
Sutton
SM2 5PT
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research (UK)

Sponsor details

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Charity

Website

http://www.icr.ac.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Department of Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes