Can an antiviral make radiation more effective against cervical cancer?
NCT ID NCT02515877
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This phase 1 trial is testing whether adding the antiviral drug Vistide (cidofovir) to the standard combination of radiation and chemotherapy can improve outcomes for people with HPV-positive cervical cancer. The idea is that Vistide may make cancer cells more sensitive to radiation by interfering with the viral proteins that help the cancer grow. The study includes about 15 adults with advanced cervical cancer and will focus on finding the safest dose and understanding side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vistide (cidofovir) combined with standard external radiotherapy, brachytherapy, and carboplatin chemotherapy
- What this could lead to
- If successful, this approach could enhance the effectiveness of standard radiochemotherapy for cervical cancer, potentially improving local control and survival rates.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the benefits are uncertain. The antiviral may not enhance treatment as hoped, and there is a risk of increased side effects from the combination.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
15 people
The number who actually took part.
- Start date
-
Jan 2008
- Finished
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Apr 2013
- 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 to 70 years
- 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: 1. Patients with cervix cancer : Squamous cell carcinoma or adenocarcinoma of stage IB2\> 4 cm, II, III or IVA (International Federation of Gynecology Obstetrics, regardless of pelvic lymph node status (optional surgical exploration) without paraaortic metastasis. 2. Detection of the virus genome of HPV positive on the primary tumor. 3. General state ECOG performance status 0-1. 4. 18 \</ = age \</ = 70 years. 5. PN\> 2000 / mm3 6. hemoglobin\> 9 g/l after transfusion if necessary . 7. platelets \> 100 000 / mm3 8. Serum creatinine \<1.5 upper limit of normal. 9. Liver function tests (SGOT, SGPT, alkaline phosphatase and bilirubin) \<1.5 upper limit of normal. 10. Life expectancy\> 3 months. 11. Systematic Beta HCG Dosage for premenopausal women. 12. Informed consent signed after informing the patient. 13. Proteinuria \<2g / L (200mg / dL) and creatinine clearance of\> / = 55 ml / min. Exclusion Criteria: 1. Other histological types of cervix tumor than those mentioned in the inclusion criteria. 2. Search of viral sequences on the negative HPV tumor diagnosis. 3. History of cancer other than basal cell carcinoma. 4. Pre-treatment with radiotherapy or chemotherapy. 5. Ongoing pregnancy. 6. History or active psychiatric illness. 7. Nephropathy whatever the grade. 8. Infection scalable. 9. Active infection or other serious underlying pathology may prevent the patient receiving the treatment (in particular hepatic or cardiac). 10. Inclusion in another clinical trial protocol with an experimental molecule (during the study or within one month before inclusion). 11. Inability to submit to medical monitoring study for geographical, social or psychological.
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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
-
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805, France
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Other studies related to the condition(s) this trial covers.
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