Evaluer l’aptitude/capacité de la radiothérapie moderne de diminuer l'incidence de la toxicité hématologique sévère due à l'irradiation de la moelle osseuse et à la chimiothérapie concomitante.
Les objectifs secondaires seront :
1/ D’évaluer la dosimétrie des facteurs prédictifs de toxicité médullaire
2/ Déterminer la nécessité d’une administration de facteur de stimulation des colonies de granulocytes (G-CSF) ou transfusions sanguines
3/ Evaluation de la durée totale du traitement (radiochimiothérapie et curiethérapie)
4/Evaluer la toxicité aiguë
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D’inclusion :
3- Histologically confirmed cancer of the uterine cervix: squamous cell carcinoma (SCC), adenocarcinoma, or adenosquamous carcinoma.
4-Locally advanced cervical cancer staged by the International Federation of Gynecology and Obstetrics classification (FIGO 2018) (confirmed by clinical staging and/or imaging)
5-Stage FIGO IB3-IVA in whom definitive radio-chemotherapy with curative intent is planned
6-No evidence of metastatic disease outside the para-aortic area by primary staging (including clinical examination, pelvic MRI, 18-FDG PET, +/- laparoscopic para-aortic lymph node staging).
7- Adequate haematologic and end-organ function, defined by the following laboratory results obtained within 15 calendar days prior to the first study treatment:
a. Absolute neutrophil count (ANC) ≥1,500/mm3 (≥1.5 x 109/L) without granulocyte colony-stimulating factor (G-CSF) support.
b. Total white blood cells (WBC) >2,000/mm3 (>2.0 x 109/L) (including Polymorphonuclear neutrophils > 1,500/mm3 or 1.5 x 109/L)
c. Lymphocyte count ≥500/mm3 (≥ 0.5 x 109/L)
d. Platelet count ≥ 100,000/mm3 (≥ 100 x 109/L) without transfusion.
e. Haemoglobin ≥ 9.0 g/dL (90 g/L; patients may be transfused to meet this criterion).
De non inclusion :
1. Histological types of cervical cancer other than those listed in the inclusion criteria (based on FIGO 2018 classification), including:
a. Stage IB1, IB2 and IIA cervical cancer with no regional lymph node metastases (N0).
b. Stage IVB cervical cancer with presence of distant metastases other than para-aortic lymph node metastases.
2. Prior surgery for cervical cancer unless cone resection and paraaortic lymphadenectomy.
3. Prior pelvic radiotherapy, other radiotherapy, chemotherapy or immunotherapy.
4. Any malignancy other than the disease under study in the past 5 years excepting skin cancers such as BCC or SCC.
5. Pregnant or lactating women, or intending to become pregnant during the study.
6. For patient ≥ 70 years old with a G-8 score ≤ 14, unconfirmation of patient eligibility done by the onco-geriatrian at screening.
7. Any contraindication to the use of cisplatin and/or carboplatin.
8. Peripheral neuropathy ≥grade 2.
9. Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomisation. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed.
Traitement de données mené dans l'intérêt public dans le domaine de la santé publique (article 6.1e et 9.2.j du Règlement (UE) n°2016/679)
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Les données seront conservées pendant la durée légale en vigueur ou tant qu'elles présenteront un intérêt scientifique