Radiotherapy After Primary Chemotherapy for Breastcancer (RAPCHEM)

This study is currently recruiting participants.
Verified February 2014 by Maastricht Radiation Oncology
Sponsor:
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: February 27, 2014
Last verified: February 2014
  Purpose

The primary aim of the study is to evaluate the 5 yr locoregional recurrence rate (LRR) in cT1-2cN0-1(cytology/histology and/or positive SN, excluding patients with > 3 pathologic axillary nodes on imaging) breast cancer patients, treated with neoadjuvant chemotherapy, breast surgery, and radiotherapy that is protocolized based on the pathology findings after chemotherapy and definitive surgery (ypTNM stage).


Condition Intervention
Breast Cancer
Radiation: radiation - no radiation see intervention description
Radiation: radiation: see intervention description

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 year locoregional recurrence rate (LRR) in cT1-2cN0-1(cytology/histology and/or positive SN, excluding patients with > 3 pathologic axillary nodes on imaging) 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 relapse free survival rate [ Time Frame: 5 Yr ] [ Designated as safety issue: No ]
    5 year relapse free survival rate (all events except lost to follow-up, invasive contralateral cancer, and secondary primary (non-breast) invasive cancer).

  • 10 yr relapse free survival rate [ Time Frame: 10 Yr ] [ Designated as safety issue: No ]
    10 year relapse free survival rate (all events except lost to follow-up, invasive contralateral cancer, and secondary primary (non-breast) invasive cancer).

  • 15 Yr relapse free survival rate (all events except lost to follow-up, invasive contralateral cancer, and secondary primary (non-breast) invasive cancer). [ Time Frame: 15 Yr ] [ Designated as safety issue: No ]
    and 15 year relapse free survival rate (all events except lost to follow-up, invasive contralateral cancer, and secondary primary (non-breast) invasive cancer).

  • 5 Yr overall survival rate [ Time Frame: 5 Yr ] [ Designated as safety issue: No ]
    5 year overall survival rate

  • 10 Yr overall survival rate [ Time Frame: 10 yr ] [ Designated as safety issue: No ]
    10 year overall survival rate

  • 15 Yr overall survival rate [ Time Frame: 15 Yr ] [ Designated as safety issue: No ]
    15 year overall survival rate


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. Low risk
  1. Surgical strategy is full axillary lymph node dissection after primary systemic treatment and in case of:

    a. all nodes negative: ycN0

    or

  2. Surgical strategy is sentinel node procedure only performed prior to primary systemic treatment and in case of:

    a. only micrometastases in the SN, and no risk factors (grade 3, LVI, tumour size > 3 cm)

    or

  3. Surgical strategy is sentinel node procedure only performed after primary systemic treatment and in case of:

    1. no metastases in the post chemo SN
Radiation: radiation - no radiation see intervention description
after MRM in group 1 (low risk): no radiotherapy after BCT in group 1 (low risk): radiation treatment of the breast with boost (optional)
Group 2: Intermediate risk
  1. Surgical strategy is full axillary lymph node dissection after primary systemic treatment and in case of:

    a. 1-3 nodes positive: ypN1

    or

  2. Surgical strategy is sentinel node procedure only performed prior to primary systemic treatment and in case of:

    1. micrometastases in the SN and at least 1 risk factor; or
    2. ≤ 2 macrometastases and no risk factor

    or

  3. Surgical strategy is sentinel node procedure only performed after primary systemic treatment and in case of:

    1. micrometastases in the post chemo SN and no risk factors (grade 3, LVI, tumour size > 3 cm)
Radiation: radiation: see intervention description
after BCT in group 2 (intermediate risk): radiation treatment of the breast with boost (optional) after MRM in group 2 (intermediate risk): radiation treatment of the thoracic wall If no full ALND is performed in group 2 (intermediate risk) add radiation treatment of level 1 and 2 of the axilla.
Group 3. High risk
  1. Surgical strategy is full axillary lymph node dissection after primary systemic treatment and in case of:

    a. 4 or more nodes positive: ypN2

    or

  2. Surgical strategy is sentinel node procedure only performed prior to primary systemic treatment and in case of:

    1. ≤ 2 macrometastases in the sentinel node prior to primary systemic treatment in the presence of risk factors like Grade 3, lymphangioinvasion, tumour size > 3 cm; or
    2. 3 macrometastases, 2 macrometastases and 1 micrometastase, 1 macrometastase and 2 micrometastases.

    or

  3. Surgical strategy is sentinel node procedure only performed after primary systemic treatment and in case of:

    1. Micrometastases in the post chemo SN, and at least one risk factor
    2. ≤ 3 macrometastases in the post chemo SN; or
    3. 2 macrometastases and 1 micrometastase, 1 macrometastase and 2 micrometastases
Radiation: radiation: see intervention description
after MRM in group 3 (high risk): radiation treatment of the thoracic wall and supraclavicular nodes after BCT in group 3 (high risk): radiation treatment of the breast with boost (optional) and supraclavicular nodes If no full ALND is performed group 3 (high risk) add radiation treatment of level 1 and 2 of the axilla.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with cT1-2cN0-1(cytology/histology and/or positive SN, excluding patients with > 3 pathologic axillary nodes on imaging) breast cancer, treated with at least three cycles of chemotherapy followed by breast surgery are eligible for the study.

Criteria

Inclusion criteria:

  • cT1-2 invasive breast cancer, without or 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 primary systemic treatment have been given (irrespective of the regimen)
  • No standard axillary lymph node dissection is performed prior to chemotherapy

Exclusion criteria:

  • cT3-T4 invasive breast cancer prior to any treatment
  • Patients with > 3 suspicious axillary nodes on imaging
  • cN2-3 prior to any treatment
  • More than focally irradical surgery and breast conserving therapy

To investigate whether a patient is eligible for the RAPCHEM study, a meticulous examination of the axilla is necessary. Therefore each patient should undergo an ultrasound of the axilla and if possible an ultrasound guided needle biopsy UNB (FNA or core). The US/UNB can be performed instantly or as second look in case of enlarged nodes on MRI. The criteria for performing an UNB are:

  • Cortex >2.3 mm not measured at the poles of the node; or
  • Disappearance of the fatty hilum; or
  • Asymmetric bulging of the cortex of a lymph node;

If a PET-CT is performed the worst outcome of the two studies is accepted as the real clinical stage of the axilla (i.e. 1 PA proven positive lymph node on ultrasound and 3 on PET-CT; means 3 positive lymph nodes)

The N status of the axilla prior to chemotherapy is based upon:

  • Positive PET-CT of more than one but less than 4 axillary nodes; since the specificity of PET positive nodes in a proven breast cancer patient is very high, pathology confirmation is not absolutely required
  • Positive US of axillary nodes; at least one should be pathology proven tumour positive
  • The worst outcome of 1 and 2 represents the most reliable clinical axillary staging.
  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         
UMC St Radboud Nijmegen Recruiting
Nijmegen, Gelderland, Netherlands
Contact: L. Strobbe         
Principal Investigator: L. Strobbe         
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         
UMC Utrecht Recruiting
Utrecht, Netherlands
Contact: R. Pijnappel         
Principal Investigator: R. Pijnappel         
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: February 27, 2014
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
relapse free survival
cT1-2cN0-1 breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014