Radiotherapy After Primary Chemotherapy for Breastcancer (RAPCHEM)
This study is currently recruiting participants.
Verified December 2012 by Maastricht Radiation Oncology
Sponsor:
Maastricht Radiation Oncology
Collaborators:
The Netherlands Cancer Institute
Diakonessen Hospital Utrecht
Information provided by (Responsible Party):
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01279304
First received: January 17, 2011
Last updated: December 27, 2012
Last verified: December 2012
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Purpose
The primary aim of the study is to evaluate the 5 yr locoregional recurrence rate (LRR) in cT1-2cN1(cytology/histology and/or positive SN, excluding patients with > 3 pathologic axillary nodes on ultrasound or MRI) breast cancer patients, treated with neo-adjuvant chemotherapy, breast surgery, and radiotherapy that is protocolised based on the pathology findings after chemotherapy and definitive surgery (ypTNM stage).
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Radiation: no radiotherapy Radiation: radiotherapy of the thoracic wall Radiation: radiotherapy of thoracic wall/breast AND supraclavicular nodes |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Radiotherapy After Primary CHEMotherapy for cT1-2cN1M0 Breast Cancer.: a Multicentre Prospective Registration Study. |
Resource links provided by NLM:
Further study details as provided by Maastricht Radiation Oncology:
Primary Outcome Measures:
- locoregional recurrence rate [ Time Frame: 5 Yr ] [ Designated as safety issue: No ]to evaluate the 5 yr locoregional recurrence rate (LRR) in cT1-2cN1(cytology/histology and/or positive SN, excluding patients with > 3 pathologic axillary nodes on ultrasound or MRI) breast cancer patients, treated with neo-adjuvant chemotherapy, breast surgery, and radiotherapy that is protocolised based on the pathology findings after chemotherapy and definitive surgery (ypTNM stage).
Secondary Outcome Measures:
- risk model based on rick factors [ Time Frame: 5 yr ] [ Designated as safety issue: No ]to develop a risk model based on risk factors, that can be used to predict which of the patients with a cT1-2cN1 breast carcinoma, treated with neoadjuvant chemotherapy and surgery, have a 5 yr LRR > 8 % if radiotherapy is withheld.
- 10 year LRR [ Time Frame: 10 Yr ] [ Designated as safety issue: No ]10 year Locoregional Recurrence Rate
- 5 Yr overall survival rate [ Time Frame: 5 yr ] [ Designated as safety issue: No ]and 5 yr overall survival rates.
- 10 Yr overall survival rate [ Time Frame: 10 yr ] [ Designated as safety issue: No ]and 10 yr overall survival rates.
- 15 Yr overall survival rate [ Time Frame: 15 yr ] [ Designated as safety issue: No ]and 15 yr overall survival rates.
| Estimated Enrollment: | 710 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Group 1: ypT0-2N0 |
Radiation: no radiotherapy
after MRM: no radiotherapy after BCT: radiation treatment of the breast with boost
|
| Group 2: ypT0-2N1 |
Radiation: radiotherapy of the thoracic wall
after MRM: radiation treatment of the thoracic wall after BCT: radiation treatment of the breast with boost
|
| Group 3:ypT0-2N2-3,ypT3-4N0-1,ypT3-4N0-3 |
Radiation: radiotherapy of thoracic wall/breast AND supraclavicular nodes
after MRM: radiation treatment of the thoracic wall and supraclavicular nodes after BCT: radiation treatment of the breast with boost, and supraclavicular nodes
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
patients with cT1-2cN1(cytology/histology and/or positive SN, excluding patients with > 3 pathologic axillary nodes on ultrasound or MRI) breast cancer, treated with at least three cycles of chemotherapy followed by breast and axillary surgery are eligible for the study.
Criteria
Inclusion Criteria:
- cT1-2 invasive breast cancer, with one or more pathologically proven tumour positive axillary lymph nodes (either by sentinel node biopsy, ultrasound/palpation guided biopsy or fine needle aspiration)
- At least 3 cycles of neoadjuvant chemotherapy have been given (irrespective of the regimen)
- No standard axillary lymph node dissection is performed prior to chemotherapy
- Axillary lymph node dissection performed after chemotherapy
Exclusion Criteria:
- cT3-T4 invasive breast cancer prior to any treatment
- cN2-3 prior to any treatment, or > 3 or less pathological nodes on ultrasound or MRI
- More than focally irradical surgery and breast conserving therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279304
Contacts
| Contact: L.J. Boersma | 0031884455666 | liesbeth.boersma@maastro.nl |
| Contact: R Houben | 0031884455666 | ruud.houben@maastro.nl |
Locations
| Netherlands | |
| Dr. B. Verbeeten Institute | Recruiting |
| Tilburg, Brabant, Netherlands | |
| Contact: Ph. Poortmans | |
| Principal Investigator: Ph Poortmans | |
| Maastro clinic | Recruiting |
| Maastricht, Limburg, Netherlands, 6229 ET | |
| Contact: Liesbeth Boersma, MD, Ph.D 0031 - (0)88 44 55 666 liesbeth.boersma@maastro.nl | |
| Principal Investigator: L.J Boersma | |
| The Netherlands Cancer Institute | Recruiting |
| Amsterdam, Noord-holland, Netherlands | |
| Contact: P. Elkhuizen | |
| Principal Investigator: P Elkhuizen | |
| Diakonessen Hospital Utrecht | Recruiting |
| Utrecht, Netherlands | |
| Contact: T van Dalen | |
| Principal Investigator: T van Dalen | |
Sponsors and Collaborators
Maastricht Radiation Oncology
The Netherlands Cancer Institute
Diakonessen Hospital Utrecht
Investigators
| Principal Investigator: | L.J Boersma | Maastricht University Medical Centre |
| Principal Investigator: | A Voogd | Maastricht University |
| Principal Investigator: | R Houben | Maastricht University Medical Centre |
More Information
No publications provided
| Responsible Party: | Maastricht Radiation Oncology |
| ClinicalTrials.gov Identifier: | NCT01279304 History of Changes |
| Other Study ID Numbers: | 10-04-10/02 |
| Study First Received: | January 17, 2011 |
| Last Updated: | December 27, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht Radiation Oncology:
|
breast cancer locoregional recurrence rate neoadjuvant chemotherapy and surgery radiotherapy |
risk model overall survival cT1-2cN1M0 breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013