drugset / Trial / NCT05358704

Preoperative ChemoRadiation And FOLFOXIRI for Rectal Cancer (CRAFTER) for Rectal Cancer

NCT05358704 ↗

Phase 2 Suspended 38 enrolled Rutgers, The State University of New Jersey
NaSingle-groupOpen-labelTreatment

Summary

To evaluate the safety and preliminary efficacy of Preoperative ChemoRadiation and FOLFOXIRI and to Escalate Complete Response for Rectal Cancer patients.Go through laboratory and medical tests to verify eligibility to enter the study, receive the experimental combination of drugs (chemoradiation (capecitabine and radiation) + FOLFOXIRI (Oxaliplatin, leucovorin, irinotecan, and fluorouracil) prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three to four years. The time in the study will take approximately four to six hours during pre-study, study and end of study visits.

Timeline

Start
2022-05-13
Primary completion
2027-12-30
Completion
2028-01-30

Outcome

Outcome not reported

Stopped: “no slots available”

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule — —
Subject Irinotecan Small molecule — —
Subject Leucovorin Small molecule — —
Subject Oxaliplatin Small molecule — —
Subject fluorouracil Small molecule — —

Indications