Reduction of Hematologic Toxicity in Locally Advanced Cervical Cancers

Inclusion criteria

• Signed informed consent specific to the study.
• Age ≥ 18 years. Patients aged over 70 must be screened using the G-8 geriatric assessment tool; if required (G-8 score ≤ 14), an onco-geriatric consultation is mandatory to confirm eligibility.
• Histologically confirmed cervical cancer: squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
• Locally advanced cervical cancer according to the FIGO 2018 classification, confirmed by clinical staging and/or imaging.
• FIGO stage IB3 to IVA, for which definitive chemoradiotherapy with curative intent is planned.
• No evidence of metastatic disease outside the para-aortic region at initial staging (clinical exam, pelvic MRI, FDG-PET, and/or para-aortic lymph node staging by laparoscopy if applicable).
• Adequate hematologic and organ function, defined as laboratory results within 15 days prior to first study treatment:

Absolute neutrophil count (ANC) ≥ 1,500/mm³ without G-CSF support Total white blood cells > 2,000/mm³ Lymphocytes ≥ 500/mm³ Platelet count ≥ 100,000/mm³ without transfusion Hemoglobin ≥ 9.0 g/dL (transfusion allowed to meet this criterion)

• Patients eligible to receive cisplatin or carboplatin-based concurrent chemotherapy, with or without prior carbo-taxol neoadjuvant chemotherapy (as discussed in the protocol comments).
• Women of childbearing potential must have a negative pregnancy test (β-HCG) within 7 days before treatment and commit to highly effective contraception until 6 months after chemotherapy.

Exclusion criteria

• Histologic types of cervical cancer other than those listed in the inclusion criteria.
• FIGO IB1, IB2, or IIA stages without regional lymph node metastasis (N0).
• FIGO IVB cervical cancer with distant metastases beyond para-aortic lymph nodes.
• Previous surgery for cervical cancer, except conization or para-aortic lymphadenectomy.
• Previous pelvic radiotherapy, other radiotherapy, or immunotherapy, except allowed neoadjuvant chemotherapy.
• Any malignancy other than the study disease within the past 5 years, except non-melanoma skin cancers (BCC, SCC).
• Pregnant or breastfeeding women, or women planning pregnancy during the study.
• For patients ≥70 with G-8 ≤14: non-confirmation of eligibility by the onco-geriatrician.
• Contraindication to cisplatin and/or carboplatin.
• Peripheral neuropathy ≥ grade 2.
• Systemic corticosteroids or systemic immunosuppressive drugs within 2 weeks before randomization (inhaled corticosteroids and mineralocorticoids such as fludrocortisone are allowed).
• Untreated osteoporosis (T-score ≤ -3) diagnosed on bone densitometry performed within 6 months prior to inclusion.