Clinical trials: sponsored by UNICANCER
Pancreatic Cancer, Carcinoma
A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma
French national multicentric phase III trial evaluating chemotherapy with Folfirinox or gemcitabine in locally advanced pancreatic carcinoma.
- Trial name
- NEOPAN (NCT02539537)
- Testing
- Gemcitabine, Folinic Acid, 5-Fluoro-uracil
- Where
- 45 sites in France
- Volunteers
- 171 people
- Sponsor
- UNICANCER
Breast Cancer
Phase I Evaluating the Combination of Ribociclib+Capecitabine in Locally Advanced/Metastatic Breast Cancer HER2 Negative
The proposed study is a multicenter, open-label phase I trial, conducted in locally advanced or metastatic breast cancer HER2 negative patients and divided into 2 parts: STEP 1: a dose escalation part (n= up to 30) to evaluate…
- Trial name
- GEP14-LEECAP (NCT02754011)
- Testing
- Combination of ribociclib + capecitabine
- Where
- 2 sites in France
- Volunteers
- 18 people
- Sponsor
- UNICANCER
Breast Neoplasm Female
Concordance of the IHC4 Score Performed in Local or Central Laboratory to Endopredict in ER+/HER2- Breast Cancer
Retrospective observational, multicentric study assessing the immunohistochemistry (IHC) based test IHC4 score in infiltrating early breast cancer: comparison of the score performed in local laboratory vs in a central laboratory…
- Trial name
- GEFPICS IHC4 (NCT04246606)
- Testing
- IHC4 score
- Where
- France
- Volunteers
- 155 people
- Sponsor
- UNICANCER
Adenocarcinoma of the Stomach, Adenocarcinoma of the Gastroesophageal Junction
Regorafenib Combined With Irinotecan as Second-line in Patients With Metastatic Gastro-oesophageal Adenocarcinomas
Trial evaluating the efficacy of regorafenib combined with irinotecan compared to irinotecan alone in second-line treatment of patients with metastatic gastro-oesophageal adenocarcinomas.
- Trial name
- REGIRI (NCT03722108)
- Testing
- Regorafenib and Irinotecan, Irinotecan
- Where
- 27 sites in France
- Volunteers
- 89 people
- Sponsor
- UNICANCER
Rectal Carcinoma
Neoadjuvant Treatment for Advanced Rectal Carcinoma
The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine) to a short course RT associated with a delayed surgery, with two primary objectives: the efficacy evaluation (rate of R0 resection) and…
- Trial name
- NACRE (NCT02551237)
- Testing
- 50 Gy, Capecitabine, 25 Gy
- Where
- 37 sites in France
- Volunteers
- 103 people
- Sponsor
- UNICANCER
Breast Cancer
Prospective Study Assessing EndoPredict® Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer
The trial population of this study is composed of women aged more than 18, who have developed a newly node-negative (or pN1mi), Estrogen Receptor (ER)-positive, Her2-negative invasive breast cancer with uncertainty on the…
- Trial name
- ADENDOM (NCT02773004)
- Testing
- EPClin genomic test
- Volunteers
- 203 people
- Sponsor
- UNICANCER
Metastatic, Breast Cancer
Cohort Study of Prospective Validation of Predictive Factors and Biological Imaging of Response to Bevacizumab and Paclitaxel in Patients With Metastatic Breast Cancer
Bevacizumab plus chemotherapy improves response rates and prolongs PFS when used as first- and second-line therapy for advanced breast cancer. However, bevacizumab has not improved OS in the individual studies currently reported.
- Trial name
- COMET (NCT01745757)
- Testing
- Bevacizumab, paclitaxel
- Where
- 19 sites in France
- Volunteers
- 510 people
- Sponsor
- UNICANCER
Prostate Cancer
Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens.
- Trial name
- NCT00055731
- Testing
- bicalutamide, Goserelin Acetate, docetaxel
- Where
- 38 sites in France
- Volunteers
- 413 people
- Sponsor
- UNICANCER
Recurrent and/or Metastatic Platinum-refractory SCCHN
Nivolumab in Recurrent and/or Metastatic SCCHN
Recurrent and/or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) are a common clinical situation and although this group of patients has very heterogeneous disease characteristics, they share a dismal prognosis…
- Trial name
- TopNIVO (NCT03226756)
- Testing
- Nivolumab Injection
- Where
- 18 sites in France
- Volunteers
- 351 people
- Sponsor
- UNICANCER
Breast Cancer, PI3K, Alpelisib
SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer
SAFIR PI3K is an open-label multicenter phase II randomized trial, comparing alpelisib plus fulvestrant to maintenance chemotherapy in patient PIK3CA mutated with HR+/Her2- metastatic breast cancer who do not present progressive…
- Trial name
- SAFIR-PI3K (NCT03386162)
- Testing
- Alpelisib, Chemotherapy
- Where
- 14 sites in France
- Volunteers
- 31 people
- Sponsor
- UNICANCER
Breast Cancer Female, Triple Negative and Androgen Receptor Positive
Study on Androgen Receptor and Triple Negative Breast Cancer
This is a multicenter uncontrolled, open-label, prospective, non-comparative randomized, phase II study. Patients will be randomized between darolutamide in Arm n°1 (two-stage Simon's design) and capecitabine in Arm n°2 with two…
- Trial name
- START (NCT03383679)
- Testing
- Darolutamide, Capecitabine
- Where
- France
- Volunteers
- 94 people
- Sponsor
- UNICANCER
Metastatic Breast Cancer
Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor
This is a prospective biomarker study to show that p4EBP1 staining predicts clinical benefit from treatment with everolimus in patients who are eligible for everolimus+exemestane treatment.
- Trial name
- SAFIR-TOR (NCT02444390)
- Testing
- Biopsy
- Where
- 12 sites in France
- Volunteers
- 150 people
- Sponsor
- UNICANCER
Metastatic Cancers
EXPRESS: EXcePtional RESponSe - Exceptional and Unexpected Response to Targeted Therapies
Adult patients with metastatic or locally advanced solid malignancies (including but not limited to breast, cancer, lung adenocarcinoma or squamous cell carcinoma, colorectal cancer, ovarian cancer, renal clear cell cancer, skin…
- Trial name
- EXPRESS (NCT02701907)
- Testing
- Blood sampling
- Where
- 36 sites in France
- Volunteers
- 182 people
- Sponsor
- UNICANCER
Oncology
COVID-19 Detection Test in Oncology
EVIDENCE is a non interventional, French, multicenter study. Patients will be screened by local severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoassay in their oncology department (rapid diagnostic test (RDT) or…
- Trial name
- EVIDENCE (NCT04367870)
- Where
- 7 sites in France
- Volunteers
- 441 people
- Sponsor
- UNICANCER
Biochemically-relapsing Prostate Adenocarcinoma Following Radical Prostatectomy
Radiotherapy Plus Hormone Therapy in Biochemically-relapsing Prostate Cancer Patients Following Surgery
As there is no prospective data on the combination of abiraterone and salvage radiotherapy, the aim of this study is to further evaluate the safety profile of abiraterone acetate plus prednisone in patients with prostate cancer…
- Trial name
- CARLHA (NCT01780220)
- Testing
- Abiraterone
- Where
- 5 sites in France
- Volunteers
- 47 people
- Sponsor
- UNICANCER
Squamous Cell Carcinoma of Head and Neck
Evaluation of Bintrafusp Alfa in Operable and Untreated Head and Neck Squamous Cell Carcinoma
This study is a prospective open label, multicenter, phase II, window-of-opportunity preoperative, single-agent trial. This study aims to evaluate the efficacy, the safety and tolerability profile of bintrafusp alfa in patients…
- Trial name
- ICING (NCT04428047)
- Testing
- bintrafusp alfa
- Where
- 8 sites in France
- Volunteers
- 7 people
- Sponsor
- UNICANCER
Metastatic Colorectal Cancer
Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)
National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed…
- Trial name
- TIME (NCT02404935)
- Testing
- Cetuximab, FOLFIRI and cetuximab
- Where
- 47 sites in France
- Volunteers
- 139 people
- Sponsor
- UNICANCER
Neoadjuvant Operable Breast Cancer
Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women
The investigators propose in the present study an innovative approach, combining the most recent therapeutic opportunities in high risk ER+ breast cancer with the most recent and innovative diagnostic approaches such as the PAM50…
- Trial name
- NeoPAL (NCT02400567)
- Testing
- Fluorouracile, Epirubicin, Cyclophosphamide
- Where
- 2 sites in France
- Volunteers
- 125 people
- Sponsor
- UNICANCER
Prostate Carcinoma, Castration-resistant Prostate Cancer
Treatment of Metastatic Castrate Resistant Prostate Cancer Patients According to Circulating Tumor Cells Kinetic
This study compares the biological activity of cabazitaxel (6 cycles) to that of docetaxel (6 cycles) in metastatic castrate-resistant prostate cancer (mCRPC) patients with docetaxel resistant mCRPC defined as ≥5 circulating…
- Conditions
- Prostate Carcinoma, Castration-resistant Prostate Cancer, Circulating Tumor Cells, Chemotherapy
- Trial name
- TACTIK (NCT03101046)
- Testing
- Cabazitaxel, Docetaxel
- Where
- 5 sites in France
- Volunteers
- 40 people
- Sponsor
- UNICANCER
Carcinoma, Squamous Cell of Head and Neck
Research of Biomarkers of Activity and Efficacy of BIBW2992 in Untreated Non-metastatic HNSCC Patients
The purpose of this study is to identify predictive and pharmacodynamic biomarkers of activity and efficacy of pre-operative Afatinib (BIBW2992) in untreated non-metastatic head and neck squamous cell carcinoma patients
- Trial name
- PREDICTOR (NCT01415674)
- Testing
- Afatinib
- Where
- 11 sites in France
- Volunteers
- 61 people
- Sponsor
- UNICANCER