A clinical trial testing a one week schedule of whole breast radiotherapy a... | Recruiting
A clinical trial testing a one week... | Recruiting
A clinical trial testing a one week schedule of whole breast radiotherapy against a three week schedule
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Medical Conditions
  • Breast cancer
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN19906132
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-giving-1-week-radiotherapy-breast-cancer-fast-forward
Research Details
  • To identify a 5-fraction schedule of curative radiotherapy delivered in one week that is at least as effective and safe as the UK standard 15-fraction regimen after primary surgery for early breast cancer.
Phase
Phase III
Study Design
Phase III randomised controlled multi centre trial
Study Type
Interventional
Intervention

Patients will be randomised equally between a standard 3 week schedule and two 1 week test schedules of whole breast radiotherapy

Whole breast radiotherapy schedules:
Standard group - 40Gy in 15 fractions over 15 days (not weekends)
Test group 1 - 27Gy in 5 fractions over 5 days (not weekends)
Test group 2 - 26Gy in 5 fractions over 5 days (not weekends)

Patients will be followed up for a minimum of 10 years.

There are Quality of Life and a photographic sub-studies, each with 2196 patients. Quality of Life questionnaires will be completed at baseline, 6, months and 2, 5 and 10 years post randomisation. Photographs will be taken at baseline and 2, 5 and 10 years post randomisation.

Intervention Type
Other
Primary Outcome Measures
    Ipsilateral local tumour control: Will be reported at the annual follow up visits. The tests will be performed when the need arises i.e. when the patient feels unwell or reports another lump etc. The tests will be carried out as routine clinical examinations i.e. X rays, computerised tomography (CT) scans, magnetic resonance imaging (MRI), ultrasound.
Secondary Outcome Measures
    1. Early and late adverse effects in normal tissues
    2. Quality of life at baseline, 6, months and 2, 5 and 10 years post randomisation
    3. Contralateral primary tumours, regional and distant metastases
    4. Survival
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
4000
Participant Inclusion Criteria
    1. Age more than or equal to 18 years
    2. Female or male
    3. Invasive carcinoma of the breast
    4. Breast conservation surgery or mastectomy (reconstruction allowed but not with implant. Tissue expanders with distant metal ports are allowed)
    5. Axillary staging and/or dissection
    6. Complete microscopic excision of primary tumour
    7. Stage pT1-3 pN0-1 M0 disease
    8. Written informed consent
    9. Able to comply with follow up

    Concurrent trastuzumab and hormone therapy is allowed
Participant Exclusion Criteria
    1. Past history of malignancy except basal cell skin cancer and cervical intraepithelial neoplasia (CIN) or non-breast malignancy allowed if treated with curative intent and at least 5 years disease free
    2. Contralateral breast cancer, including ductal carcinoma in-situ (DCIS), irrespective of date of diagnosis
    3. Breast reconstruction using implants
    4. Concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed)
    5. Radiotherapy to any regional lymph node areas (excepting lower axilla included in standard tangential fields to breast/chest wall)
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Trial Contact(s)
Primary Trial Contact
Prof John Yarnold
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Randomised clinical trial testing a one week course of curative whole breast radiotherapy against a standard three week schedule in terms of local cancer control and late adverse effects in patients with early breast cancer
EudraCT Number
Sorry, this information is not available
Funder(s)
  • NIHR Health Technology Assessment Programme - HTA (UK) (09/01/47)
Other Study ID Numbers
HTA 09/01/47, ICR-CTSU/2010210026
Sponsor(s)
The Institute of Cancer Research (UK)
Key Dates

Recruitment Start Date

01 Sep 2011

Recruitment End Date

01 Sep 2025

Trial Start Date

01 Sep 2011

Trial End Date

01 Sep 2025

Date added to source

31 May 2011

Date updated in source

29 Jan 2013