Study of a Predictor for Cervix Cancer

Oncology Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01641484
• Other study ID #: ANOXICOL-1102
• Status: Terminated
• Phase: N/A
• First received: July 6, 2012
• Last updated: July 19, 2017
• Start date: January 2012
• Est. completion date: February 2015

Study information

• Verified date: July 2017
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Persistence of tumor hypoxia could be a predictive factor of local control

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervix Cancer
• Oncology
• Uterine Cervical Neoplasms

Intervention

Procedure:
• local control at 19.8Gy
Day 14, full body TEP and pelvis MRI

Locations

Country	Name	City	State
France	Oscar Lambret Center	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	safety	NCI CTCAE v 4.0	baseline, Day 14, Day 45, Day 120
Secondary	MRI and TEP local control evaluation		4 months
Secondary	impact of tumor hypoxia on necrosis appearance	necrosis quantification from biopsies	Day 45 and Day 120
Secondary	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