Study of a Predictor for Cervix Cancer (ANOXICOL)
Primary Purpose
Cervix Cancer, Oncology
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
local control at 19.8Gy
Sponsored by
About this trial
This is an interventional other trial for Cervix Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria :
- 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
- 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
Sites / Locations
- Oscar Lambret Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
local control 19.8Gy
Arm Description
local control at 19.8 Gy, at Day 14
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
safety
NCI CTCAE v 4.0
MRI and TEP local control evaluation
impact of tumor hypoxia on necrosis appearance
necrosis quantification from biopsies
correlation between biomarkers of tumor hypoxia evolution and local control
evaluate necrosis appearance as a proxy to local control
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01641484
Brief Title
Study of a Predictor for Cervix Cancer
Acronym
ANOXICOL
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
unreached recruitment objectives
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Cancer, Oncology
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
local control 19.8Gy
Arm Type
Experimental
Arm Description
local control at 19.8 Gy, at Day 14
Intervention Type
Procedure
Intervention Name(s)
local control at 19.8Gy
Intervention Description
Day 14, full body TEP and pelvis MRI
Primary Outcome Measure Information:
Title
change from baseline of value of persisting hypoxia at day 14
Description
dynamic MRI : tumor volume, intensity of contrast enhancement (Ktrans and SI10 measurement) TEP scan : metabolic intensity, SUV measurement comparison of biopsie negativity
Time Frame
Baseline, Day 14
Secondary Outcome Measure Information:
Title
safety
Description
NCI CTCAE v 4.0
Time Frame
baseline, Day 14, Day 45, Day 120
Title
MRI and TEP local control evaluation
Time Frame
4 months
Title
impact of tumor hypoxia on necrosis appearance
Description
necrosis quantification from biopsies
Time Frame
Day 45 and Day 120
Title
correlation between biomarkers of tumor hypoxia evolution and local control
Description
evaluate necrosis appearance as a proxy to local control
Time Frame
baseline, Day 14, Day 45 and Day 120
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria :
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nickers Philippe, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oscar Lambret Center
City
Lille
ZIP/Postal Code
59020
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of a Predictor for Cervix Cancer
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