Cervical cancer is the fourth most common cancer among women and is mainly linked to infection with high-risk human papillomaviruses (HPV). Although most HPV infections resolve spontaneously, 570,000 women were diagnosed with cervical cancer in 2018, and more than half of them died from the disease.
For locally advanced disease, concurrent chemoradiotherapy (RT-CT) followed by brachytherapy is considered the standard therapeutic treatment. Even though progress has been made in chemotherapy, external beam radiotherapy, and brachytherapy over the past decades-on the one hand by reducing the duration of chemotherapy-induced cytotoxicity, and on the other hand by decreasing radiation doses delivered to organs at risk-hematologic toxicity following concurrent chemoradiotherapy remains a frequent complication.
The indication and benefit of chemotherapy have been demonstrated in phase III clinical trials; however, grade 3 hematologic toxicity (anemia, leukopenia, and thrombocytopenia) remains between 18.7% and 21.3%. Since total treatment duration is a prognostic factor for local control, brachytherapy must be administered near the end of or immediately after RT-CT so that total treatment time is as short as possible (≤ 50 days). If grade 3 hematologic toxicity persists after RT-CT (prior to brachytherapy), brachytherapy will be delayed, leading to a loss of disease control (Tanderup et al., 2016).
Dose reduction to the bone marrow is possible, but to date no randomized trial has evaluated it. The objective of this multicenter French study is to assess whether bone-sparing-contouring of the pelvic and/or lumbosacral osseous structures as an organ at risk (OAR) during external radiotherapy planning-reduces the incidence of grade ≥ 3 hematologic toxicity and the use of leukocyte growth factors, platelet transfusions, and/or blood transfusions, while adhering to current recommendations and without compromising clinical outcomes in patients treated with RT-CT and brachytherapy for locally advanced cervical cancer.
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.
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.
Parallel
radiotherapy with bone marrow contouring
Radiationradiotherapy delivered while contouring the bone marrow to reduce hematologic toxicity
Number of Participants With Grade ≥3 Hematologic Toxicity (CTCAE v5.0)
Incidence of grade ≥3 hematologic toxicity (anemia, neutropenia, thrombocytopenia) assessed using CTCAE v5.0.
Number of Participants With Grade ≥3 Hematologic Toxicity at Follow-up
Incidence of grade ≥3 hematologic toxicity assessed using CTCAE v5.0.
Mean Bone Marrow Dose (Gy)
Mean dose to pelvic bone marrow structures extracted from treatment planning DVH.
Number of Participants Requiring Supportive Treatments
Number of participants requiring at least one of the following: G-CSF, platelet transfusion, or red blood cell transfusionons.
Overall treatment duration
Number of days between start of radiotherapy and end of brachytherapy.
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Institut Paoli-Calmettes
Lead sponsor
Programme Hospitalier de Recherche Clinique Inter-Régionale (PHRC-I)
Collaborator
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