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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00237-34 | Other Identifier | ANSM |
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unreached recruitment objectives
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local control 19.8Gy | Experimental | local control at 19.8 Gy, at Day 14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| local control at 19.8Gy | Procedure | Day 14, full body TEP and pelvis MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| safety | NCI CTCAE v 4.0 | baseline, Day 14, Day 45, Day 120 |
| MRI and TEP local control evaluation | 4 months | |
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Inclusion Criteria:
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Nickers Philippe, MD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oscar Lambret Center | Lille | 59020 | France |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| impact of tumor hypoxia on necrosis appearance |
necrosis quantification from biopsies |
| Day 45 and Day 120 |
| correlation between biomarkers of tumor hypoxia evolution and local control | evaluate necrosis appearance as a proxy to local control | baseline, Day 14, Day 45 and Day 120 |
| D002577 |
| Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |