Clinical trial NCT02428842: Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
Official title: Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical cancer
Tumor biopsies
Standard treatment
Molecular profile
Next Generation Sequencing
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 419
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.


Eligibility criteria: Inclusion Criteria:

1. No prior treatment for cervical cancer.
2. FIGO Stage IB1 to IVB; all histological subtypes (excluding neuro-endocrine type).
3. Pelvic MRI available or planned before the start of treatment, , if FIGO ≥ IB2. and optional for IB1 stage
4. Possibility to communicate imaging data by CD-ROM (format DICOM 3.0 or more).
5. Disease amenable to biopsy (3 tumour samples are mandatory prior to treatment).
6. Age ≥ 18 years.
7. ECOG (Eastern Cooperative Oncology Group) 0-2.
8. Life expectancy \> 6 months.
9. Patient eligible for standard treatment (according to standards of each center).
10. Patient having health care insurance.
11. Informed and signed consent by patient.

(DICOM = Digital Imaging and Communications in Medicine)

Exclusion Criteria:

1. Patient enrolled in a clinical trial involving an investigative new agent.
2. Co morbidity, preventing patient to tolerate the proposed standard treatment.
3. Past history of invasive cancer over the 5 years preceding entry in the present trial (except basal cell carcinoma and carcinoma in situ of the cervix).
4. Impossibility to carry out evaluation by MRI (patient claustrophobic, pacemaker, metallic implant, non availability, other), ), if FIGO ≥ IB2 .
5. Patient deprived from ability to decide on her own.
6. Patient unable to have a regular follow up for geographical, social or psychological reasons.
7. Pregnancy or patient old enough to procreate and not using effective contraceptive method.

Primary outcomes:
measure: Correlation between tumor biological profile and treatment response.
timeFrame: up to 6 months
Secondary outcomes:
measure: Progression Free Survival evaluation
timeFrame: up to 18 months
measure: Standard treatment description (Description of primary treatment course regarding : - Initial FIGO ( International Federation of Gynecology and Obstetrics ) staging at baseline - Geographic location(country)
timeFrame: up to six months
measure: Standard treatment's side effects description (assessed by compiling grade 3 and 4 sides effects during and after treatment (according to NCI CTCAE v4.03 scale - National Cancer Institute Common Toxicity Criteria for Adverse Effects)
timeFrame: up to 6 months
measure: Molecular tumor alterations description (Description of molecular tumor alterations regarding geographic location (country)
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Bichat
state: Ile De France
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest - Paul Papin
city: Bordeaux
country: France
facility: Institut Bergonié
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil - CHI Créteil
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: Institut Régional du Cancer de Montpellier - Val D'Aurelle
city: Nancy
country: France
facility: Institut de Cancérologie de Lorraine - ICL
city: Nantes
country: France
facility: Institut de Cancérologie de l'Ouest - RENE GAUDUCHEAU
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Insitut Curie
city: Paris
country: France
facility: Hôpital Tenon
city: Saint-Cloud
country: France
facility: Institut René Huguenin
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine- ICL NANCY
city: Villejuif
country: France
facility: Institut de Cancerologie Gustave Roussy
city: Hannover
country: Germany
facility: Mhh Hanover - Hanover Medical School
city: Amsterdam
country: Netherlands
facility: Amsterdam Medical Center (AMC)
state: Meibergdreef
city: Amsterdam
country: Netherlands
facility: Netherland Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL)
city: Brasov
country: Romania
facility: Teo Health S.A. - Spitalul Sf. Constantin
city: Oradea
country: Romania
facility: Spitalul Clinic Municipal "Gavril Curteanu"
city: Timisoara
country: Romania
facility: Clinica de radioterapie
city: Sremska Kamenica
country: Serbia
facility: Clinic for operative oncology, Institute of oncology of Vojvodina
Study officials:
References:
citation: Ngo C, Samuels S, Bagrintseva K, Slocker A, Hupe P, Kenter G, Popovic M, Samet N, Tresca P, von der Leyen H, Deutsch E, Rouzier R, Belin L, Kamal M, Scholl S; RAIDs consortium http://www.raids-fp7.eu/. From prospective biobanking to precision medicine: BIO-RAIDs - an EU study protocol in cervical cancer. BMC Cancer. 2015 Nov 4;15:842. doi: 10.1186/s12885-015-1801-0.