| NCT#: | NCT05610163 |
| NCT QR Code |  |
| Title: | A022104 – Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation (JANUS) |
| Protocol: | A022104 |
| Cancer Type: | Rectal Cancer |
| Study Sponsor: | Alliance/NCI |
| Brief Summary: | This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer. |
| Study Type: | Interventional |
| Date Opened at SVH: | February 15, 2022 |
| Recruitment Status: | Recruiting |
| Study Population: | |
| Eligibility Criteria: | See SCHEMA |
| Principal Investigator: | Geetha N. Varma, MD, Oncology, Salinas Valley Health Cancer Care, (831) 755-1701 |
| Participating Institution: | Salinas Valley Health |
| Salinas Valley Health Clinical Research Program: | Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, [email protected] |
| Link to ClinicalTrials.gov: | https://clinicaltrials.gov/ct2/show/record/NCT05610163?term=A022104&draw=2&rank=1 |
| Schema | Schema |
(Tumor Board) & Other Clinical Trials at Salinas Valley Health
