Clinical trials: sponsored by UNICANCER
Breast Cancer
Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment
The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test.
- Trial name
- ASTER 70s (NCT01564056)
- Testing
- HORMONOTHERAPY, CHEMOTHERAPY then HORMONOTHERAPY
- Where
- 84 sites in Belgium, France
- Volunteers
- 1,989 people
- Sponsor
- UNICANCER
Lung Cancer Metastatic, Renal Cell Carcinoma
Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO
Immunotherapy (IO), such as treatment with anti-PD-1, PD-L1, or CTLA-4 inhibitors, is a rapidly expanding treatment for multiple metastatic cancers with improved survival for certain cancers.
- Conditions
- Lung Cancer Metastatic, Renal Cell Carcinoma, Head and Neck Cancer, Triple Negative Breast Cancer
- Trial name
- MOIO (NCT05078047)
- Testing
- Reduced dose intensity of IO
- Where
- 33 sites in France
- Volunteers
- 646 people
- Sponsor
- UNICANCER
Adenoid Cystic Carcinoma of the Salivary Gland, Recurrence
Study to Evaluate the Efficacy of Zanzalintinib in the Treatment of Relapsed or Metastatic Adenoid Cystic Carcinomas of the Head and Neck
Adenoid cystic carcinomas are rare cancers of the salivary glands. These cancers are treated with curative surgery, often followed by radiation therapy.
- Conditions
- Adenoid Cystic Carcinoma of the Salivary Gland, Recurrence, Metastatic Disease
- Trial name
- ZANACC (NCT07682675)
- Testing
- Zanzalintinib
- Where
- 2 sites in France
- Volunteers
- 51 people
- Sponsor
- UNICANCER
Malignant Melanoma, BRAF V600 Mutation
Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis
This study evaluates the addition of stereotactic radiosurgery (SRS) to the combination of binimetinib + encorafenib + pembrolizumab in the treatment of BRAFⱽ⁶⁰⁰ mutation-positive melanoma with brain metastases (MBM).
- Conditions
- Malignant Melanoma, BRAF V600 Mutation, Brain Metastases
- Trial name
- BEPCOME-MB (NCT04074096)
- Testing
- Stereotaxic radiosurgery (SRS), Binimetinib Oral Tablet, Encorafenib Oral Capsule
- Where
- 21 sites in France
- Volunteers
- 10 people
- Sponsor
- UNICANCER
Ovarian Cancer
Evolution of the Therapeutic Care in Ovarian Cancer From 2011
The ESME Ovarian Cancer database is a multi-center real life database using a retrospective data collection process in 18 French Comprehensive Cancer Center (FCCC) over 20 sites).
- Trial name
- ESME OC (NCT03275298)
- Where
- 20 sites in France
- Volunteers
- 13,331 people
- Sponsor
- UNICANCER
Lung Cancer
Evolution of the Therapeutic Care in Lung Cancer in France Since 2015 (ESME LC)
This database compiles data from existing data available from patient's electronic medical records (EMR) at the 38 participating hospitals (20 French comprehensive cancer centers and 18 public hospitals).
- Trial name
- NCT03848052
- Where
- 21 sites in France
- Volunteers
- 75,000 people
- Sponsor
- UNICANCER
Metastatic Breast Cancer
Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008
The Epidemiological Strategy and Medical Economic (ESME) Breast cancer Database is a multicenter real life database using a retrospective data collection process across 18 French comprehensive cancer centers (FCCC) spread over 20…
- Trial name
- ESME-MBC (NCT03275311)
- Where
- 20 sites in France
- Volunteers
- 42,000 people
- Sponsor
- UNICANCER
Colorectal Adenocarcinoma Metastatic in the Liver, Colorectal Cancer
Liver-directed Chemotherapy After Surgery of Liver Metastases of Colorectal Cancer in Patients With High Risk of Recurrence of Their Disease
At the time of diagnosis, 25% of patients with colorectal cancer present with liver metastasis (CRLM). Among patients with localized colorectal cancer (Stages I-III), 50% to 70% will develop liver metastases during the course of…
- Trial name
- PACHA-02 (NCT07284394)
- Testing
- Arterial catheter infusion chemotherapy, IV Chemotherapy (Regimen 1)
- Volunteers
- 272 people
- Sponsor
- UNICANCER
Head and Neck Squamous Cell Carcinoma, Anal Cancer
Blood Biomarkers Based Screening for HPV-driven OPC
The objective of our study is to demonstrate that it is possible to detect and treat human papilloma virus (HPV)-related oropharyngeal cancers (OPC) early using simple blood tests.
- Conditions
- Head and Neck Squamous Cell Carcinoma, Anal Cancer, Human Papilloma Virus
- Trial name
- SCREEN-HPV (NCT06528353)
- Testing
- HPV16-E6 serology and HPV ctDNA
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- UNICANCER
Breast Cancer
Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib
The advent of CDK4/6 inhibitors (drugs designed to block the action of CDK4/6 proteins, which play a key role in cell proliferation) has improved treatment prospects for patients with metastatic breast cancer whose tumour cells…
- Trial name
- NoLEEta (NCT07237256)
- Testing
- Chemotherapy followed by endocrine therapy and ribociclib treatment, De-escalation
- Where
- 138 sites in France, Germany and 3 more
- Volunteers
- 3,902 people
- Sponsor
- UNICANCER
Ovarian Epithelial Cancer Recurrent
Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment
CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median Overall Survival (OS) by 12 months.
- Trial name
- CHIPOR (NCT01376752)
- Testing
- Maximal cytoreductive surgery, HIPEC
- Where
- 33 sites in Belgium, France and 1 more
- Volunteers
- 415 people
- Sponsor
- UNICANCER
Oxaliplatin-induced Peripheral Neuropathy
Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy.
It is a phase II trial, randomized, parallel, double blind, multicenter, comparing riluzole versus placebo. The trial population is composed of patients ≥18 years old that have developed stage II/III colorectal cancer and are…
- Trial name
- RILUZOX-01 (NCT03722680)
- Testing
- Riluzole
- Where
- 16 sites in France
- Volunteers
- 80 people
- Sponsor
- UNICANCER
Breast Cancer Stage IV, Radiotherapy
Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases.
- Conditions
- Breast Cancer Stage IV, Radiotherapy, Surgery
- Trial name
- PALATINE (NCT03870919)
- Testing
- Palbociclib, locoregional treatment
- Where
- 26 sites in France
- Volunteers
- 200 people
- Sponsor
- UNICANCER
Unilateral Breast Neoplasms
Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk
Radiotherapy after breast cancer surgery can lead to side effects like arm lymphedema (arm swelling). Lymphedema can cause long-term discomfort and affect quality of life.
- Trial name
- PRE-ACT-01 (NCT07187726)
- Testing
- XAINET AI tool
- Where
- 27 sites in France, Netherlands
- Volunteers
- 724 people
- Sponsor
- UNICANCER
Metastatic Colorectal Cancer
Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases
The goal of this clinical trial is to evaluate the superiority of ivonescimab combined with FOLFIRI over FOLFIRI + bevacizumab as second-line treatment of non resectable pMMR/MSS BRAFwt mCRC patients without liver metastases in…
- Trial name
- COLIBRI-GI (NCT07359456)
- Testing
- Ivonescimab, Bevacizumab, FOLFIRI Protocol
- Where
- 22 sites in France
- Volunteers
- 130 people
- Sponsor
- UNICANCER
Osteosarcoma
Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients
Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as…
- Trial name
- SARCOME13 (NCT03643133)
- Testing
- Mifamurtide, EI or M-API regimen depending on patient age
- Where
- 31 sites in France
- Volunteers
- 60 people
- Sponsor
- UNICANCER
Biliary Tract Neoplasms
Personalized Medicine for Advanced Biliary Cancer Patients
The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment.
- Trial name
- SAFIR-ABC10 (NCT05615818)
- Testing
- Futibatinib, Ivosidenib, Zanidatamab
- Where
- 69 sites in Belgium, France and 1 more
- Volunteers
- 800 people
- Sponsor
- UNICANCER
Metastatic Esophageal Adenocarcinoma, Advanced Esophageal Adenocarcinoma
Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma
The goal of this clinical trial is to evaluate the addition of ivonescimab to standard chemotherapy in patients with advanced or metastatic gastric and gastroesophageal adenocarcinoma.
- Conditions
- Metastatic Esophageal Adenocarcinoma, Advanced Esophageal Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Advanced Gastric Adenocarcinoma
- Trial name
- GRACIE (NCT06846346)
- Testing
- Ivonescimab, FOLFOX regimen, Irinotecan
- Where
- 4 sites in France
- Volunteers
- 88 people
- Sponsor
- UNICANCER
Prostate Cancer Metastatic
ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)
This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with…
- Trial name
- GETUG-AFU 40 (NCT04916613)
- Testing
- Darolutamide 300 mg, Androgen deprivation therapy
- Where
- 95 sites in Belgium, France and 10 more
- Volunteers
- 300 people
- Sponsor
- UNICANCER
Digestive Cancer, Colorectal Cancer
Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme
The goal of this clinical trial is to establish guidelines for fluoropyrimidine dose reduction according to uracilemia in patients with DPD deficiency in the treatment of digestive cancers.
- Trial name
- FUDOSE (NCT06475352)
- Testing
- FOLFOX regimen, CAPOX regimen
- Where
- 41 sites in France
- Volunteers
- 400 people
- Sponsor
- UNICANCER