Can a higher radiation dose beat cervical cancer without more harm?
NCT ID NCT02880007
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests whether giving a higher radiation dose during brachytherapy, a type of internal radiation, can improve local control in patients with locally advanced cervical cancer. Participants receive standard external beam radiation and chemotherapy, plus a boosted brachytherapy dose aimed at the tumor. The goal is to increase the two-year local control rate from about 71% to nearly 87% while keeping severe complications below 6.5%. The study includes adults with stage IB2, II, or III cervical cancer who are eligible for curative treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- External beam radiation therapy, pulsed dose rate brachytherapy, and cisplatin chemotherapy
- What this could lead to
- If successful, this could improve local tumor control for cervical cancer patients, potentially increasing the chance of keeping the disease in check without raising serious side effects.
- What could go wrong
- This is a phase II trial with a modest number of participants, so results may not hold in larger groups. Higher radiation doses also carry a risk of increased complications, which the trial aims to keep below a set threshold.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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48 people
The number who actually took part.
- Started
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Jun 2011
- Finished
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Jul 2019
- 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * primitive cervical cancer * adenocarcinoma histologically advanced * IB2, II and III stage * curative treatment * indication of utero-vaginal brachytherapy with external radiotherapy * non-metastatic tumor and life expectancy \> 6 months * patient informed and follow possible * performance status ≤ 2 * unplanned surgery * age ≥ 18 years old * ability to provide written informed consent before the start of any study specific procedures Exclusion Criteria: * primitive endometrial cancer * other diseases * carcinoma in situ and stages ≤ B * distant metastases * history of pelvic irradiation or a first pelvic cancer * contraindication to MRI * history of subtotal or total hysterectomy * pregnant or breast feeding females * inability to support low dose rate continuous brachytherapy or pulsed flow * person in emergencies * person unable to give personally consent * patient participating in another clinical research except in case of local recurrence or observational research
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHRU Tours - Hôpital Bretonneau
Tours, 37044, France
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CHU de Besançon
Besançon, 25030, France
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Centre Claudius Regaud
Toulouse, 31052, France
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Centre Georges-François Leclerc
Dijon, 21079, France
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Centre Léon Bérard
Lyon, 69373, France
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Centre Paul Strauss
Strasbourg, 67065, France
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Centre Val d'Aurelle
Montpellier, 34298, France
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Institut Bergonié
Bordeaux, 33076, France
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Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
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Other studies related to the condition(s) this trial covers.
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- Can adding radiation boost the power of immunotherapy in advanced cervical cancer?
- New smart chemo targets tumors, spares healthy tissue
- Prehabilitation boosts pelvic floor recovery in cervical cancer patients
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- Study aims to find best surgery to preserve fertility in cervical cancer patients