Cervix CancerANOXICOLNCT01641484
Study of a Predictor for Cervix Cancer
A study of Cervix Cancer and Oncology, run by Centre Oscar Lambret at 1 site in France.
Trial summary
Non operated cervix cancer are usually treated by radio-chemotherapy. Non control local rate is inexplicably close to 30%. However, important volume of those tumors and their hypoxia degree induce phenomenon of pathologic angiogenesis, explaining these therapeutic failures. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervix Cancer, Oncology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Feb 2015
- Phase
- Interventional
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cervix epidermoid cancer or adenocarcinoma : I to IIIB
- treatment by radiochemotherapy
- ECOG ≤ 1
- social and psychological compliance for standard treatment of radiochemotherapy for cervix carcinoma
- patient affiliated to health insurance system
- signed informed consent
Who cannot join
- contraindication to chemoradiotherapy
- resequable cervical cancer
- para-aortic metastases histologically proven
- inability to perform an abdominal MRI or a PET Scan
- contraindications related to MRI: pacemaker, vascular clip, and all devices incompatible with the electromagnetic field generated by MRI
- unbalanced diabete
Show all 12Show fewer
- administration of EPO
- transfusion within 3 days before the first biopsy
- creatinine clearance under 60 mL / min;
- ANC <1500 / mm3 and Platelets <120,000 / mm3
- neuropathy, diabetes (fasting glucose greater than 140 mg / l) or any other condition that strongly contraindicates concomitant chemotherapy with radiotherapy
- sigmoid diverticulitis, Crohn's disease or systemic disease, collagenose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Evaluating Predictive Value of Local Control at 19.8 (MRI and TEP Scan) for Patient With Stade I to IIIB Cervix Carcinoma Treated by Radiotherapy
Non operated cervix cancer are usually treated by radio-chemotherapy. Non control local rate is inexplicably close to 30%. However, important volume of those tumors and their hypoxia degree induce phenomenon of pathologic angiogenesis, explaining these therapeutic failures.
Persistence of tumor hypoxia could be a predictive factor of local control
Read the detailed description
HPV linked cervix cancer is the second most prevalent form of female cancer. It's also the leading cause of death by cancer in Asia, South America and Africa. Hopefully, screening program lead to a 50 % of mortality reduction during the past 40 years. Classic therapeutic strategy consists of external pelvic radiation therapy associated with chemotherapy and followed by brachytherapy. Curative surgical removal is realized 4 to 6 weeks after radiation therapy. However relapse rate is frequent (20 to 30%). Biological mechanisms involved in this high relapse rate are not understood.
Nevertheless, it is suggest that initial hypoxia of cervix tumor during 20 Gy radiation therapy is a pejorative prognostic factor. At the opposite, the amelioration of tumor vascularisation during 20 Gy radiation therapy is a positive prognostic factor. It's possible that an amelioration of hypoxia lead to lesser tumor resistance to radiotherapy. However such possibility has to be test during clinical trial.
Thus, the objective of ANOXICOL study is to evaluate the predictive value of persistent hypoxia, during 20 Gy radiation therapy associated with chemotherapy, for local control of cervix cancer.
- Conditions
- Cervix Cancer, Oncology
- Being tested
- local control at 19.8Gy
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local control at 19.8GyProcedure or surgery
Day 14, full body TEP and pelvis MRI
| Study group | Role | What they receive |
|---|---|---|
| local control 19.8Gy | Experimental | local control at 19.8 Gy, at Day 14 Receives: Procedure: local control at 19.8Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline of value of persisting hypoxia at day 14
dynamic MRI : tumor volume, intensity of contrast enhancement (Ktrans and SI10 measurement) TEP scan : metabolic intensity, SUV measurement comparison of biopsie negativity
Measured: Baseline, Day 14
Secondary outcomes (4)
safety
NCI CTCAE v 4.0
Measured: baseline, Day 14, Day 45, Day 120
MRI and TEP local control evaluation
Measured: 4 months
impact of tumor hypoxia on necrosis appearance
necrosis quantification from biopsies
Measured: Day 45 and Day 120
correlation between biomarkers of tumor hypoxia evolution and local control
evaluate necrosis appearance as a proxy to local control
Measured: baseline, Day 14, Day 45 and Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionFeb 2015
Why it stopped: unreached recruitment objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nickers Philippe, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641484
- Sponsor's protocol ID
- ANOXICOL-1102
- Other IDs
- 2011-A00237-34
- Acronym
- ANOXICOL
- Status last verified
- Mar 2026
- First submitted
- 6 Jul 2012
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating Predictive Value of Local Control at 19.8 (MRI and TEP Scan) for Patient With Stade I to IIIB Cervix Carcinoma Treated by Radiotherapy
- ClinicalTrials.gov ID
- NCT01641484
- Acronym / sponsor ID
- ANOXICOL / ANOXICOL-1102
- Conditions
- Cervix Cancer, Oncology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unreached recruitment objectives
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Jul 2012 (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.
Non operated cervix cancer are usually treated by radio-chemotherapy. Non control local rate is inexplicably close to 30%. However, important volume of those tumors and their hypoxia degree induce phenomenon of pathologic angiogenesis, explaining these therapeutic failures.
Persistence of tumor hypoxia could be a predictive factor of local control
Detailed description
HPV linked cervix cancer is the second most prevalent form of female cancer. It's also the leading cause of death by cancer in Asia, South America and Africa. Hopefully, screening program lead to a 50 % of mortality reduction during the past 40 years. Classic therapeutic strategy consists of external pelvic radiation therapy associated with chemotherapy and followed by brachytherapy. Curative surgical removal is realized 4 to 6 weeks after radiation therapy. However relapse rate is frequent (20 to 30%). Biological mechanisms involved in this high relapse rate are not understood.
Nevertheless, it is suggest that initial hypoxia of cervix tumor during 20 Gy radiation therapy is a pejorative prognostic factor. At the opposite, the amelioration of tumor vascularisation during 20 Gy radiation therapy is a positive prognostic factor. It's possible that an amelioration of hypoxia lead to lesser tumor resistance to radiotherapy. However such possibility has to be test during clinical trial.
Thus, the objective of ANOXICOL study is to evaluate the predictive value of persistent hypoxia, during 20 Gy radiation therapy associated with chemotherapy, for local control of cervix cancer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| local control 19.8Gy | Experimental | Procedure: local control at 19.8Gylocal control at 19.8 Gy, at Day 14 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- cervix epidermoid cancer or adenocarcinoma : I to IIIB
- treatment by radiochemotherapy
- ECOG ≤ 1
- social and psychological compliance for standard treatment of radiochemotherapy for cervix carcinoma
- patient affiliated to health insurance system
Key exclusion criteria (12 listed)
- contraindication to chemoradiotherapy
- resequable cervical cancer
- para-aortic metastases histologically proven
- inability to perform an abdominal MRI or a PET Scan
- contraindications related to MRI: pacemaker, vascular clip, and all devices incompatible with the electromagnetic field generated by MRI
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 |
|---|---|---|
| local control at 19.8GyDay 14, full body TEP and pelvis MRI | Procedure or surgery | local control 19.8Gy |
Primary outcome
change from baseline of value of persisting hypoxia at day 14
Time frame: Baseline, Day 14
dynamic MRI : tumor volume, intensity of contrast enhancement (Ktrans and SI10 measurement) TEP scan : metabolic intensity, SUV measurement comparison of biopsie negativity
4 secondary outcomes
safety
Time frame: baseline, Day 14, Day 45, Day 120
MRI and TEP local control evaluation
Time frame: 4 months
impact of tumor hypoxia on necrosis appearance
Time frame: Day 45 and Day 120
correlation between biomarkers of tumor hypoxia evolution and local control
Time frame: baseline, Day 14, Day 45 and Day 120
Results and safety
The study was stopped early (reason given: unreached recruitment objectives). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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. This study is not recruiting at the moment.
Nickers Philippe, MD principal investigator
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cervix Cancer and Oncology, run by Centre Oscar Lambret 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 6 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: stopped early, as of the sponsor's last update on 13 Mar 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.
Are results available for this study?
The study was stopped early (reason given: unreached recruitment objectives). Results are not available in the source record.
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?
change from baseline of value of persisting hypoxia at day 14 (time frame: Baseline, Day 14). 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 13 Mar 2026.