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| Therapy Name | Fluorouracil + Leucovorin + Oxaliplatin |
| Synonyms | FOLFOX |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Fluorouracil | Adrucil | 5-FU|5-Fluorouracil | Chemotherapy - Antimetabolite 14 | Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent that interferes with DNA and RNA synthesis, thereby preventing cancer cell growth (PMID: 28520376). Adrucil (fluorouracil) is FDA-approved for use in patients with adenocarcinoma of the colon, rectum, breast, stomach, and pancreas (FDA.gov). |
| Leucovorin | Wellcovorin | Calcium folinate|Calcium citrovorum factor|folinic acid | Chemotherapy - Antimetabolite 14 | Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554). |
| Oxaliplatin | Eloxatin | Diaminocyclohexane Oxalatoplatinum | Chemotherapy - Platinum 7 | Eloxatin (oxaliplatin) is comprised of a platinum complex, which causes DNA-platinum cross-links, inhibition of DNA replication and transcription, and cell toxicity, and is FDA approved for colorectal cancer (FDA.gov). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ATM W1058* ATM S1993fs | gastroesophageal adenocarcinoma | predicted - sensitive | Fluorouracil + Leucovorin + Oxaliplatin | Case Reports/Case Series | Actionable | In a retrospective analysis, treatment with the combination of Adrucil (fluorouracil), Wellcovorin (leucovorin), and Eloxatin (oxaliplatin) resulted in a partial response and a progression-free survival of 7.2 months in a patient with gastroesophageal adenocarcinoma harboring ATM W1058* and S1993fs (PMID: 37129948). | 37129948 |
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03281369 | Phase Ib/II | Atezolizumab + Cobimetinib Atezolizumab + Cisplatin + Fluorouracil + Tiragolumab Atezolizumab + Cisplatin + Fluorouracil Atezolizumab + Cobimetinib + Fluorouracil + Leucovorin + Oxaliplatin Atezolizumab + Fluorouracil + Leucovorin + Oxaliplatin Atezolizumab + Linagliptin Atezolizumab + PEGPH20 Atezolizumab + BKT140 Paclitaxel + Ramucirumab Cisplatin + Fluorouracil Fluorouracil + Leucovorin + Oxaliplatin Atezolizumab + Tiragolumab | A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer) | Completed | USA | ISR | GBR | ESP | AUS | 2 |
| NCT05476796 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Nivolumab + Oxaliplatin + Trifluridine-tipiracil hydrochloride Oxaliplatin + Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin | Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer (LOGICAN) | Recruiting | FRA | 0 |
| NCT03844750 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Pembrolizumab | Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery | Terminated | USA | 0 |
| NCT06625320 | Phase III | Fluorouracil + Leucovorin + Liposomal irinotecan Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Gemcitabine + Nab-paclitaxel Daraxonrasib | Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 302) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | 2 |
| NCT03611556 | Phase Ib/II | Gemcitabine + Nab-paclitaxel + Oleclumab Durvalumab + Gemcitabine + Nab-paclitaxel + Oleclumab Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oleclumab + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Oleclumab + Oxaliplatin | MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study | Completed | USA | NOR | ESP | AUS | 0 |
| NCT04793958 | Phase III | Adagrasib + Cetuximab Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin | Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10) | Active, not recruiting | USA | ROU | POL | NLD | ITA | IRL | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 12 |
| NCT07318389 | Phase I | Tucatinib Fluorouracil + Irinotecan + Leucovorin Sotorasib Cetuximab Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Oxaliplatin Adagrasib Encorafenib Trastuzumab deruxtecan Bevacizumab Panitumumab | ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer | Not yet recruiting | USA | 0 |
| NCT05713838 | Phase II | Durvalumab + Fluorouracil + Leucovorin + Oxaliplatin Docetaxel + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Durvalumab | Organ Preservation With Durvalumab-based Immunotherapy in Combination With Chemoradiation as Definitive Therapy for Early Stage Esophageal Adenocarcinoma With Indication for Radical Surgery | Recruiting | DEU | 0 |
| NCT05870800 | Phase II | Atezolizumab + Capecitabine + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin | Phase II Open-label Trial of Neoadjuvant Immunochemotherapy for Resectable Non-metastatic Colon cancER: NICER (NICER) | Recruiting | USA | 0 |
| NCT03777813 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Oxaliplatin | Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer (ARION) | Completed | FRA | 0 |
| NCT04421820 | Phase Ib/II | BOLD-100 + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours | Recruiting | USA | IRL | CAN | 1 |
| NCT04210115 | Phase III | Cisplatin + Fluorouracil + Pembrolizumab Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Cisplatin + Fluorouracil | Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) | Active, not recruiting | USA | TUR | ROU | ITA | HUN | GBR | FRA | EST | DNK | DEU | CZE | CAN | BRA | BEL | ARG | 12 |
| NCT06490536 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin Ipilimumab + Nivolumab Irinotecan + Temozolomide Fluorouracil + Leucovorin Capecitabine Fluorouracil + Irinotecan + Leucovorin Fluorouracil Capecitabine + Oxaliplatin | The Sagittarius Trial | Recruiting | ITA | ESP | DEU | 0 |
| NCT02563002 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin Cetuximab + Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Pembrolizumab | Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177) | Completed | 0 | |
| NCT05564403 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin | Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial) | Active, not recruiting | USA | 0 |
| NCT06940388 | Phase II | Capecitabine Fluorouracil + Leucovorin + Oxaliplatin + Tislelizumab Fluorouracil + Leucovorin + Oxaliplatin | Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer. (TOTAL) | Recruiting | ISR | DEU | 0 |
| NCT05253651 | Phase III | Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin | A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03) | Recruiting | USA | SVK | POL | NOR | NLD | ITA | IRL | GRC | GBR | FRA | ESP | DEU | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 6 |
| NCT04145193 | Phase II | Durvalumab + Fluorouracil + Leucovorin + Oleclumab + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Monalizumab + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | Novel Oncology Therapies in Combination With Adjuvant Chemo in High-risk MSS-CRC | Withdrawn | 0 | |
| NCT05504252 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Nivolumab | METIMMOX-2: Metastatic pMMR/MSS Colorectal Cancer - Shaping Anti-Tumor Immunity by Oxaliplatin (METIMMOX-2) | Active, not recruiting | NOR | 0 |
| NCT03647969 | Phase II | Docetaxel + Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Ipilimumab + Leucovorin + Nivolumab + Oxaliplatin | Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Gastric Cancer | Completed | DEU | 0 |
| NCT01792934 | Capecitabine + Oxaliplatin Bevacizumab + Capecitabine + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin | Chemotherapy and Maximal Tumor Debulking of Multi-organ Colorectal Cancer Metastases (ORCHESTRA) | Active, not recruiting | NLD | GBR | 0 | |
| NCT05052801 | Phase III | Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (FORTITUDE-101) | Active, not recruiting | USA | TUR | SWE | ROU | POL | NOR | LVA | LTU | ITA | ISR | IRL | HUN | GRC | FRA | EST | ESP | DNK | CZE | CAN | BRA | BGR | BEL | AUS | ARG | 13 |
| NCT03504397 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab Fluorouracil + Leucovorin + Oxaliplatin | A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. (Spotlight) | Active, not recruiting | USA | POL | ITA | ISR | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | 8 |
| NCT02934464 | Phase III | Paclitaxel + Ramucirumab Fluorouracil + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin | Assessment of Ramucirumab Plus Paclitaxel as Switch MANteInance Versus Continuation of First-line Chemotherapy in Patients With Advanced HER-2 Negative Gastric or Gastroesophageal Junction Cancers (ARMANI) | Unknown status | ITA | 0 |
| NCT07265674 | Phase III | Fluorouracil + Irinotecan + Leucovorin JPH203 Fluorouracil + Leucovorin + Oxaliplatin | A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer (Beacon-BTC) | Recruiting | USA | 0 |
| NCT03329248 | Phase Ib/II | Fluorouracil + Leucovorin + Oxaliplatin Avelumab + Bevacizumab + ETBX-011 + GI-4000 + Nogapendekin alfa inbakicept Capecitabine + Cyclophosphamide + Nab-paclitaxel | QUILT-3.060: Combination Immunotherapy With High-affinity Natural Killer (haNK) in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy. | Terminated | USA | 0 |
| NCT06997497 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Cetuximab + Fluorouracil + Leucovorin + MK-1084 + Oxaliplatin | A Clinical Study of MK-1084 With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) | Recruiting | USA | ROU | POL | NLD | ISR | GBR | FRA | FIN | ESP | DEU | BRA | AUS | ARG | 8 |
| NCT05855200 | Phase III | Dostarlimab-gxly Capecitabine + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (AZUR-2) | Recruiting | USA | TUR | SWE | POL | NOR | NLD | ITA | GRC | GBR | FRA | FIN | EST | ESP | DEU | CZE | CAN | BRA | BEL | AUS | ARG | 8 |
| NCT02912559 | Phase III | Atezolizumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair | Active, not recruiting | USA | DEU | 1 |
| NCT03530267 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Aflibercept + Fluorouracil + Leucovorin | Aflibercept and 5-FU vs. FOLFOX as 1st Line Treatment for Elderly or Frail Elderly Patients With Met. Colorectal Cancer (ELDERLY) | Completed | DEU | 0 |
| NCT06333314 | Phase II | Dostarlimab-gxly Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Doxorubicin Gemcitabine Gemcitabine + Nab-paclitaxel Doxorubicin + Trabectedin Fluorouracil + Leucovorin + Oxaliplatin Cisplatin + Etoposide Cisplatin + Gemcitabine Cisplatin + Doxorubicin + Etoposide Capecitabine + Oxaliplatin Doxorubicin + Ifosfamide Carboplatin + Etoposide Carboplatin + Paclitaxel Docetaxel + Fluorouracil + Leucovorin + Oxaliplatin Mitotane | Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI (Pan-MSI-ACSE) | Recruiting | FRA | 0 |
| NCT05564377 | Phase II | Selumetinib Binimetinib + Fulvestrant Binimetinib + Palbociclib Nilotinib + Paclitaxel Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin Panitumumab + Sotorasib Binimetinib Fulvestrant Olaparib Olaparib + Selumetinib Alpelisib + Olaparib Neratinib Neratinib + Palbociclib Fluorouracil + Leucovorin + Oxaliplatin Ipatasertib + Paclitaxel | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial | Recruiting | USA | 1 |
| NCT06529718 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Ivonescimab | Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients (SEVILLA) | Recruiting | GBR | FRA | 0 |
| NCT05062317 | Phase II | Capecitabine Leucovorin Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin | Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases | Recruiting | USA | 0 |
| NCT05062889 | Phase II | Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib | Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients (ERASE-CRC) | Suspended | ITA | 0 |
| NCT02923921 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin + Pegilodecakin Fluorouracil + Leucovorin + Oxaliplatin | Study of AM0010 With FOLFOX Compared to FOLFOX Alone Second-line Tx in Pts With Metastatic Pancreatic Cancer | Completed | USA | POL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 2 |
| NCT03694522 | Phase II | Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT) | Completed | USA | TUR | ROU | POL | ITA | HUN | GBR | FRA | ESP | DEU | BEL | AUS | 6 |
| NCT06044311 | Phase II | Carboplatin + Paclitaxel Vactosertib Fluorouracil + Leucovorin + Oxaliplatin | Oral TGF-beta Receptor I Inhibitor Vactosertib in SOC Chemoradiotherapy for Esophageal Adenocarcinoma | Recruiting | USA | 0 |
| NCT04919226 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin 177Lu-edotreotide Everolimus Capecitabine + Temozolomide | Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE) | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | AUS | 2 |
| NCT04008030 | Phase III | Nivolumab Fluorouracil + Irinotecan + Leucovorin Cetuximab Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab Ipilimumab + Nivolumab | A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (CheckMate 8HW) | Active, not recruiting | USA | TUR | ROU | NOR | NLD | ITA | IRL | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 4 |