Informations générales (source: ClinicalTrials.gov)
Multicenter Randomized Phase III Trial Comparing Hypofractionated Versus Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation in Terms of Lymphedema Occurrence (HYPOG-01)
Interventional
N/A
UNICANCER (Voir sur ClinicalTrials)
septembre 2016
septembre 2030
29 juin 2024
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Emmanuelle MALAURIE | 29/03/2024 01:27:11 | Contacter | ||
| CLCC INSTITUT CURIE | 04/09/2024 13:49:51 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Sofia RIVERA | 05/04/2024 09:57:10 | Contacter | ||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:35 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| INSTITUT DE RADIOTHERAPIE HARTMANN | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Eugene Marquis - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Galilée - Hôpital Privé La Louvière - 59800 - Lille - France | Contact (sur clinicalTrials) | ||||
| Centre Georges Francois Leclerc - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Guillaume Le Conquerant - Le Havre - France | Contact (sur clinicalTrials) | ||||
| Centre Henri Becquerel - Rouen - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Paul Strauss - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| CHU Bretonneau - 37044 - Tours - France | Contact (sur clinicalTrials) | ||||
| Clinique Chenieux - 87039 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Hôpital du Scorff - 56100 - Lorient - France | Contact (sur clinicalTrials) | ||||
| Hôpital Jean Minjoz - 25030 - Besancon - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint-Louis - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de L'Ouest-Paul Papin - Angers - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de L'Ouest-Rene Gauducheau - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - Lyon - France | Contact (sur clinicalTrials) | ||||
| ICM Val d'Aurelle - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Institut Curie- Rene Huguenin - Saint-Cloud - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de Lorraine - Nancy - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13273 - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
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
- 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
- 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.