New radiation technique aims to prevent dangerous blood drops in cervical cancer patients
NCT ID NCT07461142
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new way of planning radiation—sparing the pelvic and lower spine bones—can lower the risk of severe blood-related side effects in women with advanced cervical cancer. About 72 participants will receive standard chemoradiotherapy, but half will have their radiation plan adjusted to protect bone marrow. The goal is to reduce severe anemia, low white blood cells, and low platelets, which can delay needed follow-up treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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