Cervical Cancer by FIGO Stage 2018RETHEMCOLNCT07461142
Reduction of Hematologic Toxicity in Locally Advanced Cervical Cancers
A study testing radiotherapy with bone marrow contouring in people with Cervical Cancer by FIGO Stage 2018, run by Institut Paoli-Calmettes.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer by FIGO Stage 2018
- What is being tested?
- radiotherapy with bone marrow contouring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 30 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Cervical Cancer by FIGO Stage 2018
- Being tested
- radiotherapy with bone marrow contouring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapy with bone marrow contouringRadiation
radiotherapy delivered while contouring the bone marrow to reduce hematologic toxicity
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | patients treated according to the standard of care: chemotherapy + radiotherapy for 5 weeks + standard uterovaginal brachytherapy |
| B | Experimental | chemotherapy + radiotherapy with bone marrow contouring for 5 weeks + standard uterovaginal brachytherapy Receives: Radiation: radiotherapy with bone marrow contouring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At completion of concurrent chemoradiotherapy (Day 1 of brachytherapy planning visit).
Secondary outcomes (9)
Number of Participants With Grade ≥3 Hematologic Toxicity at Follow-up
Incidence of grade ≥3 hematologic toxicity assessed using CTCAE v5.0.
Measured: At 3 months and at 6 months after completion of concurrent chemoradiotherapy.
Mean Bone Marrow Dose (Gy)
Mean dose to pelvic bone marrow structures extracted from treatment planning DVH.
Measured: At radiotherapy treatment planning
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.
Measured: From Day 1 of chemoradiotherapy initiation up to 90 days after chemoradiotherapy completion.
Overall treatment duration
Number of days between start of radiotherapy and end of brachytherapy.
Measured: From date of first radiotherapy fraction until end of brachytherapy
Progression-free survival (PFS)
PFS is defined as the time from randomization to documented disease progression or death from any cause.
Measured: From randomization up to 3 years of follow-up.
Local control
To evaluate local disease control, defined as absence of local recurrence (complete response or stable disease without progression).
Measured: From end of treatment through all follow-up visits (up to 3 years).
Incidence of bone fractures
To estimate the incidence of bone fractures during follow-up.
Measured: During the entire follow-up period (up to 3 years).
EORTC QLQ-C30 Global Health Score
Change in QLQ-C30 global health status score (0-100 scale, higher = better).
Measured: Baseline (Day 1), end of chemoradiotherapy (Week 5), and follow-up at 3, 6, 9, 12, 16, 20, 24, 30, 36 months.
Bone marrow metabolic activity
Bone marrow SUVmax measured on PET-CT.
Measured: Baseline (before chemoradiotherapy) and post-chemoradiotherapy (Day of brachytherapy planning CT).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Jul 2028 (estimated)
- Study completion30 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer by FIGO Stage 2018Studies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- Programme Hospitalier de Recherche Clinique Inter-Régionale (PHRC-I)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461142
- Sponsor's protocol ID
- RETHEMCOL-IPC 2023-019
- Acronym
- RETHEMCOL
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Hematologic Toxicity in Locally Advanced Cervical Cancers
- ClinicalTrials.gov ID
- NCT07461142
- Acronym / sponsor ID
- RETHEMCOL / RETHEMCOL-IPC 2023-019
- Conditions
- Cervical Cancer by FIGO Stage 2018
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- Programme Hospitalier de Recherche Clinique Inter-Régionale (PHRC-I)
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 30 Aug 2031 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –patients treated according to the standard of care: chemotherapy + radiotherapy for 5 weeks + standard uterovaginal brachytherapy |
| B | Experimental | Radiation: radiotherapy with bone marrow contouringchemotherapy + radiotherapy with bone marrow contouring for 5 weeks + standard uterovaginal brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapy with bone marrow contouringradiotherapy delivered while contouring the bone marrow to reduce hematologic toxicity | Radiation | B |
Primary outcome
Number of Participants With Grade ≥3 Hematologic Toxicity (CTCAE v5.0)
Time frame: At completion of concurrent chemoradiotherapy (Day 1 of brachytherapy planning visit).
Incidence of grade ≥3 hematologic toxicity (anemia, neutropenia, thrombocytopenia) assessed using CTCAE v5.0.
9 secondary outcomes
Number of Participants With Grade ≥3 Hematologic Toxicity at Follow-up
Time frame: At 3 months and at 6 months after completion of concurrent chemoradiotherapy.
Mean Bone Marrow Dose (Gy)
Time frame: At radiotherapy treatment planning
Number of Participants Requiring Supportive Treatments
Time frame: From Day 1 of chemoradiotherapy initiation up to 90 days after chemoradiotherapy completion.
Overall treatment duration
Time frame: From date of first radiotherapy fraction until end of brachytherapy
Progression-free survival (PFS)
Time frame: From randomization up to 3 years of follow-up.
Local control
Time frame: From end of treatment through all follow-up visits (up to 3 years).
Incidence of bone fractures
Time frame: During the entire follow-up period (up to 3 years).
EORTC QLQ-C30 Global Health Score
Time frame: Baseline (Day 1), end of chemoradiotherapy (Week 5), and follow-up at 3, 6, 9, 12, 16, 20, 24, 30, 36 months.
Bone marrow metabolic activity
Time frame: Baseline (before chemoradiotherapy) and post-chemoradiotherapy (Day of brachytherapy planning CT).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing radiotherapy with bone marrow contouring in people with Cervical Cancer by FIGO Stage 2018, run by Institut Paoli-Calmettes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihane PAKRADOUNI, dr (+33 4 91 22 37 78, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Grade ≥3 Hematologic Toxicity (CTCAE v5.0) (time frame: At completion of concurrent chemoradiotherapy (Day 1 of brachytherapy planning visit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.