Cervical CancerPhase 1HPV-RXNCT02515877
Modulation of the Expression of Papillomavirus (HPV) Oncoproteins to Major the Radiosensitivity: Trial Combining an Antiviral Agent VISTIDE and Radiochemotherapy in Cervical Cancers
A Phase 1 study testing External radiotherapy + curietherapy, Vistide and Carboplatin in people with Cervical Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
The treatment of cervical tumors depends on the stage of the disease. In advanced forms (nodal and / or local extension to the vagina and / or parameters) , radiotherapy associated with curietherapy , plays a major role. Until recently this association was the standard treatment for advanced stage uterine cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- External radiotherapy + curietherapy, Vistide and Carboplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Detection of the virus genome of HPV positive on the primary tumor.
- General state ECOG performance status 0-1.
- 18 </ = age </ = 70 years.
- PN> 2000 / mm3
- hemoglobin> 9 g/l after transfusion if necessary .
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- platelets > 100 000 / mm3
- Serum creatinine <1.5 upper limit of normal.
- Liver function tests (SGOT, SGPT, alkaline phosphatase and bilirubin) <1.5 upper limit of normal.
- Life expectancy> 3 months.
- Systematic Beta HCG Dosage for premenopausal women.
- Informed consent signed after informing the patient.
- Proteinuria <2g / L (200mg / dL) and creatinine clearance of> / = 55 ml / min.
Who cannot join
- Other histological types of cervix tumor than those mentioned in the inclusion criteria.
- Search of viral sequences on the negative HPV tumor diagnosis.
- History of cancer other than basal cell carcinoma.
- Pre-treatment with radiotherapy or chemotherapy.
- Ongoing pregnancy.
- History or active psychiatric illness.
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- Nephropathy whatever the grade.
- Infection scalable.
- Active infection or other serious underlying pathology may prevent the patient receiving the treatment (in particular hepatic or cardiac).
- Inclusion in another clinical trial protocol with an experimental molecule (during the study or within one month before inclusion).
- Inability to submit to medical monitoring study for geographical, social or psychological.
Trial locations and contacts
1 site in 1 country.
France1 site
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805
About this study
Official title: Modulation of the Expression of Papillomavirus (HPV) Oncoproteins to Major the Radiosensitivity: Phase I Trial Combining an Antiviral Agent VISTIDE and Radiochemotherapy in Cervical Cancers
The treatment of cervical tumors depends on the stage of the disease. In advanced forms (nodal and / or local extension to the vagina and / or parameters) , radiotherapy associated with curietherapy , plays a major role. Until recently this association was the standard treatment for advanced stage uterine cancer. With this combination, rates of local failures (evolutionary prosecution and local recurrences) were 20 to 50% in stages IIb and 50-75 % for stage III. More than 50% for patients with a cervical cancer locally advanced (FIGO stages II / IV) . The standard treatment, external radiotherapy followed by curietherapy allows expect survival rates at 5 years for approximately 30-45 %. For ten years, numerous studies have evaluated the addition of concurrent chemotherapy to radiotherapy in cancer of the cervix. More than 19 randomized trials have been published. A meta-analysis of these trials was undertaken to assess the role of radiochemotherapy in cancers of the cervix. The first meta-analysis published by the Cochrane Collaborative Group, taking into account 4580 patient, shows an improvement in survival, both in terms of progression free survival and overall survival for patients treated with radio chemotherapy respectively 16% and 12 % (p < 0.0001). The rate of metastasis is also decreased (p < 0.0001). Survival rates were significantly better when platinum salt was used ( p < 0.0001 ) . However, no clinical benefit of chemoradiotherapy has been demonstrated for tumors stages [1, 2] locally advanced, possibly due to small number of patients. The investigators have previously shown that antiviral agents used in preclinical models, Cidofovir® causes the selective radiosensitization of cells infected by the papillomavirus (HPV). This trial proposes to study a new concept to increase radiochemotherapy efficiency: the modulation of the expression of viral oncoproteins HPV virus by an antiviral agent.
- Conditions
- Cervical Cancer
- Being tested
- External radiotherapy + curietherapy, Vistide, Carboplatin
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External radiotherapy + curietherapyRadiation
External radiotherapy: 45 Gy in 5 weeks Curietherapy: 15Gy
VistideDrug
VISTIDE® (mg/kg) Level 1: 1mg/kg Level 2: 2,5 mg/kg Level 3: 5 mg/kg Level 4: 6,5 mg/kg
CarboplatinDrug
AUC= 2,5 (Calvert formula)
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy + Vistide + Chemoterapy | Experimental | Not described Receives: Radiation: External radiotherapy + curietherapy; Drug: Vistide; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
Measured: Assessed every week after inclusion up to 10 weeks
Secondary outcomes (1)
Efficacy Using RECIST criteria
Using RECIST criteria
Measured: Assessed 14 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startJan 2008
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515877
- Sponsor's protocol ID
- 2007-005505-21
- Other IDs
- 2007/1297
- Acronym
- HPV-RX
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2015
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Deutsch E, Haie-Meder C, Bayar MA, Mondini M, Laporte M, Mazeron R, Adam J, Varga A, Vassal G, Magne N, Chargari C, Lanoy E, Pautier P, Levy A, Soria JC. Phase I trial evaluating the antiviral agent Cidofovir in combination with chemoradiation in cervical cancer patients. Oncotarget. 2016 May 3;7(18):25549-57. doi: 10.18632/oncotarget.8224.
PubMed 27016411
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of the Expression of Papillomavirus (HPV) Oncoproteins to Major the Radiosensitivity: Phase I Trial Combining an Antiviral Agent VISTIDE and Radiochemotherapy in Cervical Cancers
- ClinicalTrials.gov ID
- NCT02515877
- Acronym / sponsor ID
- HPV-RX / 2007-005505-21
- Conditions
- Cervical Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- Jan 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Aug 2015 (estimated)
- 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.
The treatment of cervical tumors depends on the stage of the disease. In advanced forms (nodal and / or local extension to the vagina and / or parameters) , radiotherapy associated with curietherapy , plays a major role. Until recently this association was the standard treatment for advanced stage uterine cancer. With this combination, rates of local failures (evolutionary prosecution and local recurrences) were 20 to 50% in stages IIb and 50-75 % for stage III. More than 50% for patients with a cervical cancer locally advanced (FIGO stages II / IV) . The standard treatment, external radiotherapy followed by curietherapy allows expect survival rates at 5 years for approximately 30-45 %. For ten years, numerous studies have evaluated the addition of concurrent chemotherapy to radiotherapy in cancer of the cervix. More than 19 randomized trials have been published. A meta-analysis of these trials was undertaken to assess the role of radiochemotherapy in cancers of the cervix. The first meta-analysis published by the Cochrane Collaborative Group, taking into account 4580 patient, shows an improvement in survival, both in terms of progression free survival and overall survival for patients treated with radio chemotherapy respectively 16% and 12 % (p < 0.0001). The rate of metastasis is also decreased (p < 0.0001). Survival rates were significantly better when platinum salt was used ( p < 0.0001 ) . However, no clinical benefit of chemoradiotherapy has been demonstrated for tumors stages [1, 2] locally advanced, possibly due to small number of patients. The investigators have previously shown that antiviral agents used in preclinical models, Cidofovir® causes the selective radiosensitization of cells infected by the papillomavirus (HPV). This trial proposes to study a new concept to increase radiochemotherapy efficiency: the modulation of the expression of viral oncoproteins HPV virus by an antiviral agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy + Vistide + Chemoterapy | Experimental | Radiation: External radiotherapy + curietherapy, Drug: Vistide, Drug: Carboplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Detection of the virus genome of HPV positive on the primary tumor.
- General state ECOG performance status 0-1.
- 18 </ = age </ = 70 years.
- PN> 2000 / mm3
Key exclusion criteria (11 listed)
- Other histological types of cervix tumor than those mentioned in the inclusion criteria.
- Search of viral sequences on the negative HPV tumor diagnosis.
- History of cancer other than basal cell carcinoma.
- Pre-treatment with radiotherapy or chemotherapy.
- Ongoing pregnancy.
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 |
|---|---|---|
| External radiotherapy + curietherapyExternal radiotherapy: 45 Gy in 5 weeks Curietherapy: 15Gy | Radiation | Radiotherapy + Vistide + Chemoterapy |
| VistideVISTIDE® (mg/kg) Level 1: 1mg/kg Level 2: 2,5 mg/kg Level 3: 5 mg/kg Level 4: 6,5 mg/kg | Drug | Radiotherapy + Vistide + Chemoterapy |
| CarboplatinAUC= 2,5 (Calvert formula) | Drug | Radiotherapy + Vistide + Chemoterapy |
Primary outcome
Dose limiting toxicity
Time frame: Assessed every week after inclusion up to 10 weeks
1 secondary outcome
Efficacy Using RECIST criteria
Time frame: Assessed 14 weeks after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Results publication: PubMed 27016411Deutsch E, Haie-Meder C, Bayar MA, Mondini M, Laporte M, Mazeron R, Adam J, Varga A, Vassal G, Magne N, Chargari C, Lanoy E, Pautier P, Levy A, Soria JC. Phase I trial evaluating the antiviral agent Cidofovir in combination with chemoradiation in cervical cancer patients. Oncotarget. 2016 May 3;7(18):25549-57. doi: 10.18632/oncotarget.8224.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing External radiotherapy + curietherapy, Vistide and Carboplatin in people with Cervical Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 13 inclusion and 11 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: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (time frame: Assessed every week after inclusion up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02515877, which also lists 1 linked publication.
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 13 Aug 2026.