Assessment Study to Evaluate Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy

NCT03255252 | Terminated Phase 2

• 1 other identifier: ICM-URC 2015/27
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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 immunomodulator) could be proposed to those selected patients in the field of personalized medicine.
• To evaluate the use of the smear as a surrogate non-invasive technique to biopsy for immunomonitoring.
• To use the CTC/PD-L1 assay as a liquid biopsy in future clinical trials for stratification and monitoring of cancer patients undergoing immune checkpoint treatments. This specific subset of CTCs might represent metastatic cells with a high potential to escape T cell-mediated lysis and might therefore be the actual targets of immunotherapy.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Expression of CD8+CD39+PD1+ lymphocytes infiltrate on cervix biopsies

  Cervix biopsies analysis

  through study completion, an average of 1 year disease free survival

Secondary Outcomes (1)

• Effect on 1-year DFS of other putative biomarkers (CD73, CD39, PD1 and Tim3) on the non-regulatory CD4+ and CD8+ lymphocytes

  through study completion, an average of 1 year disease free survival

Study Arms (1)

Cisplatin

EXPERIMENTAL

Weekly cisplatin (40 mg/m²) will be administered during radiotherapy. At least 3 cycles of cisplatin should be performed according to the hematological and renal functions but not mandatory.

Drug: Cisplatin injection; Combination Product: radiotherapy

Interventions

Cisplatin injection DRUG

Weekly cisplatin (40 mg/m²) will be administered during radiotherapy. At least 3 cycles of cisplatin should be performed according to the hematological and renal functions but not mandatory.

Cisplatin

radiotherapy COMBINATION_PRODUCT

A total dose of 45Gy in 25 fractions to the PTV is considered standard but simultaneous integrated boost or two steps boost to specific volumes (positive lymph nodes for example) are accepted and left to the investigator's discretion).

Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (3)

Clinique Beausoleil

Montpellier, 34070, France

Location

CHRU Montpellier

Montpellier, 34295, France

Location

Moussin Aurore

Montpellier, 34298, France

Location

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MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Officials

• Riou Olivier, MD

  ICM Val d'Aurelle

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: radiothérapy with concomittant chemotherapy

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 21, 2017
• Study Start: July 15, 2017
• Primary Completion: June 16, 2022
• Study Completion: November 23, 2023
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)