The standard treatment of localized breast cancers consists of surgical removal of the tumor at the breast or removal of the entire breast and lymph nodes (sentinel lymph node and / or axillary dissection) with or without chemotherapy followed by radiotherapy on the breast or thoracic wall and the lymph node areas from 5 to 6.5 weeks.
Shorter radiotherapy treatments over 3 weeks for breast cancer without lymph node involvement have been equally effective and have no more side effects in several clinical trials involving several thousand patients. This called hypofractionated radiotherapy has become a standard for breast cancers in the absence of lymph node involvement in postmenopausal women.
The objective of the HypoG01 trial is to evaluate hypofractionated radiotherapy in women who require radiotherapy in the breast or chest wall and lymph node areas by comparing standard over 5 to 6.5 weeks and hypofractionated irradiation over 3 weeks analyzing the possible side effects and in particular the risk of lymphedema (swelling of the arm on the side treated) and the effectiveness of these treatments
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* Woman ≥ 18 years who had radical surgery for invasive breast cancer pT1-3, pN0-N3, M0 with either mastectomy or breast conservation. The patient can be included no matter the status of oestrogen receptor, progesterone receptor, malignancy grade, HER2 status.
* ECOG 0-2
* Axillary lymph node dissection of the axilla where the findings give indication for regional nodes radiotherapy to levels +/-I, +/- II, +/-III, +/-IV, +/-interpectoral nodes (Rötter) and +/-the IMN.
* Sentinel node biopsy documenting limited nodal disease without an indication for axillary lymph node dissection according to institutional, national or other trial guidelines are accepted.
* The patient may be a candidate for a boost to the tumour bed.
* Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.
* Neoadjuvant chemotherapy for downstaging according to institutional or national guidelines is accepted if there is not an indication for a boost in the area of regional nodes after surgery.
* Primary systemic therapy of an operable breast cancer is accepted.
* If the patient is not treated with chemotherapy, the patient must be randomized within 8 weeks from last surgery. If the patient has received adjuvant chemotherapy, the patient must be randomized within 4 weeks after the last series of adjuvant chemotherapy or within 42 days from last surgery in case of surgery after neoadjuvant or adjuvant chemotherapy.Breast implants are accepted.
* Connective tissue disease is allowed if the treating radiation oncologist finds radiotherapy indicated
* Postoperative infection and/or seroma giving indication for drainage during RT is accepted
* Women of childbearing potential must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy
* Signed informed consent
* Affiliated to the Social Security system
Exclusion Criteria:
* Previous breast cancer or DCIS of the breast.
* Bilateral breast cancer
* Patient with previous non-breast malignancy with the exception of cancer in complete remission for over 5 years and low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ of the cervix, melanoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
* The patient has an indication for boost to 1 or more regional nodes
* Previous radiotherapy to the chest region
* Patient enrolled in another therapeutic trial. Observational cohorts are accepted if the collection of data does not interfere with the current trial
* Pregnant or lactating
* Conditions indicating that the patient cannot go through the radiation therapy or follow up, or a condition where the treating radiation oncologist thinks the patient should not participate in the trial for example due to language problems.
Primary outcome measure(s)
Arm Lymphedema — At 3 years Occurrence radiation-induced late morbidity measured as lymphedema of the arm on the treated side at 3 years after adjuvant radiotherapy as follows: At least≥ 10% increased arm circumference measured 15 cm proximal and/or 10 cm distal of the olecranon of the treated side relative to the baseline value, compared to the contralateral side circumference also relative to its baseline value.
Trial sites (28)
Facility
City
Region
Status
Clinique de l'Europe
Amiens
France
Institut de Cancerologie de L'Ouest-Paul Papin
Angers
France
Hôpital Jean Minjoz
Besançon
France
Institut Bergonie
Bordeaux
France
Centre Jean Perrin
Clermont-Ferrand
France
Hoptal Henri Mondor
Créteil
France
Centre Georges Francois Leclerc
Dijon
France
Centre Guillaume Le Conquerant
Le Havre
France
Centre de radiothérapie Hartmann
Levallois-Perret
France
Centre Galilée - Hôpital Privé La Louvière
Lille
France
Centre Oscar Lambret
Lille
France
Clinique Chenieux
Limoges
France
Hôpital du Scorff
Lorient
France
Centre Leon Berard
Lyon
France
Institut Paoli Calmettes
Marseille
France
ICM Val d'Aurelle
Montpellier
France
Institut de Cancerologie de Lorraine
Nancy
France
Centre Antoine Lacassagne
Nice
France
Hopital Saint-Louis
Paris
France
Institut Curie
Paris
France
Centre Eugene Marquis
Rennes
France
Centre Henri Becquerel
Rouen
France
Institut Curie- Rene Huguenin
Saint-Cloud
France
Institut de Cancerologie de L'Ouest-Rene Gauducheau
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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