Etude : HYPOG01 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : HYPOG01

Nom :

Traitement : Adjuvant / Radiothérapie

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 08/10/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : 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

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 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 hypofractioned 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 hypofractioned 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.

Study Arms:
- Experimental: HYPOFRACTIONATED
40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions per week.
If the patient is candidate for a boost it will be provided as follows: sequential boost with 40 Gy to CTV breast in 15 fractions and 16 Gy to CTV boost in 8 fractions
or simultaneous integrated boost (SIB) with 42.3 Gy on CTV breast and 52.2 Gy on CTV boost in 18 fractions
- NORMOFRACTIONATED
50 Gy / 25 fractions, 2.0 Gy per fraction, 5 fractions per week.
If the patient is candidate for a boost it will be provided as follows: sequential boost with 50 Gy to CTV breast in 25 fractions and 16 Gy to CTV boost in 8 fractions
or simultaneous integrated boost (SIB) with 51.52 Gy on CTV breast and 63 Gy on CTV boost in 28 fractions.

Phase : III

Stade : Localisé à Localement avancé

NA
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - 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 neoajduvant 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

Critères de non-inclusion : - 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.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03127995
Promoteur :
UNICANCER
Type de sponsor : Institutionnel
75654 Paris Cedex 13 - 75654 Paris Cedex 13
75001 PARIS 01

Coordonnateur :
Docteur Sofia RIVERA
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Pierre Curie - 1 rue Delbecque - 62660 BEUVRY

Investigateur :
Docteur Jean-Briac PREVOST

TEC / ARC / IDE :
Laetitia GALLOIS
laetitia.gallois@
radiopole-artois.com
03 21 61 92 70 - Poste : 6654

Ouverture de l'essai : OUVERT

MAJ : 06/05/2019

Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur Raphaëlle Mouttet

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Ouverture de l'essai : OUVERT

MAJ : 07/05/2019

Centre investigateur :
Centre Hospitalier de Lens - 99 Route de la Bassée - 62300 LENS

Investigateur :
Dr Jacques FOURQUET

TEC / ARC / IDE :
Quentin DHALLUIN
quentin.dhalluin@
chru-lille.fr
06.03.64.80.47

Ouverture de l'essai : OUVERT

MAJ : 08/10/2019