Status:
TERMINATED
Assessment Study to Evaluate Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Perspectives: * To set-up another clinical trial with this specific phenotype as the main stratification factor. Therefore a more aggressive or a more specific systemic treatment (with or without an ...
Detailed Description
Cervical cancer is a real worldwide health care issue. High-risk human papillomavirus (HR-HPV) chronic infection is a co-factor in the development of the cervical cancer. The HR-HPV genome encodes tw...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- HPV-positive cervical cancer proven\* by biopsy.
- All FIGO stages cervical cancers which are the matter for radio-chemotherapy and exclusive brachytherapy indications.
- ECOG performance status ≤2.
- Ability to give informed consent.
- Patients must be affiliated to a Social Security System.
- Patient information and written informed consent form signed.
Exclusion
- Adenocarcinoma of cervix.
- Known autoimmune disorder.
- History of HIV and/ or hepatitis infection.
- History of pelvic radiation or radio-chemotherapy.
- Recurrent or metastatic cervical cancer.
- Contra-indication for cisplatin.
- Patient pregnant and/or breastfeeding.
- History of other malignancy within the previous 5 years (except for appropriately treated melanoma skin carcinoma).
- Patients with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Key Trial Info
Start Date :
July 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03255252
Start Date
July 15 2017
End Date
November 23 2023
Last Update
May 18 2025
Active Locations (3)
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1
Clinique Beausoleil
Montpellier, France, 34070
2
CHRU Montpellier
Montpellier, France, 34295
3
Moussin Aurore
Montpellier, France, 34298