NCT00212121

Brief Summary

hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_3 breast-cancer

Geographic Reach
2 countries

18 active sites

Status
unknown

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

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
20.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

21.4 years

First QC Date

September 13, 2005

Last Update Submit

January 20, 2022

Conditions

Breast Cancer

Keywords

breast cancerradiotherapymicroarrays

Outcome Measures

Primary Outcomes (1)

  • Local control at 10 yr

    at every follow up visit (< 2 months after last radiation treatment and thereafter yearly

Secondary Outcomes (1)

  • Cosmetic outcome

    prior to radiotherapy, 1 year after radiotherapy and thereafter every 3 years

Study Arms (2)

1

ACTIVE COMPARATOR

low dose boost (16 Gy)

Radiation: high dose boostProcedure: boost

2

EXPERIMENTAL

high boost (26 Gy)

Radiation: high dose boostProcedure: boost

Interventions

high dose boostRADIATION

high dose boost

12
boostPROCEDURE

low dose versus high dose

12

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 50 years or younger.
  • Histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma.
  • Tumor location and extension imaged prior to surgery using at least mammography and ultrasound.
  • Unicentric tumors and multifocal tumors removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as:
  • any DCIS or invasive carcinoma in 3 or fewer low-power fields (using a x 4 objective and a x 10 ocular lens, which has a diameter of 5 mm per low-power microscopic fields).
  • Sentinel lymph node biopsy and/or axillary lymph node dissection has been performed.
  • Breast cancer stage: pT1-2pN0-2a M0.
  • No treatment is allowed prior to surgery (no neoadjuvant chemotherapy, no neoadjuvant hormonal therapy, no pre-operative radiotherapy).
  • In cases where no adjuvant chemotherapy is given, wide local excision has been performed \< 10 weeks before the start of radiotherapy.
  • In cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed \< 6 months before the start of radiotherapy, and chemotherapy should be completed \< 6 weeks before the start of radiotherapy.
  • In cases where hormonal treatment is planned, this is given after completion of the radiotherapy.
  • No previous history or synchronous malignant tumor in the other breast, previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
  • ECOG performance scale 2 or less.

You may not qualify if:

  • Residual microcalcifications on mammogram.
  • All histological types of malignancies other than invasive adenocarcinoma.
  • In situ carcinoma of the breast, without invasive tumor.
  • Concurrent pregnancy.
  • Multicentric tumors, and multifocal. tumors excised using multiple excisions \* Invasive breast cancer in both breasts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Hôpital J-Minjoz

Besançon, 25030, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

CHU Henri Mondor

Créteil, 94000, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Institut Paoli Calmettes

Marseille, 13009, France

Location

Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie

Paris, 75005, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Eugène Marquis

Rennes, 35000, France

Location

Centre Henri Becquerel

Rouen, 76000, France

Location

Centre René Huguenin

Saint-Cloud, 92210, France

Location

Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Centre Paul Strauss

Strasbourg, 67085, France

Location

CHU de Tours

Tours, 37000, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

The Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Liesbeth Boersma, MD

    MAASTRO Clinic, Heerlen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

July 1, 2004

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

NL(1)FR(17)