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Clinical trialNCT05358704SuspendedPhase 2Interventional

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

SponsorRutgers, The State University of New JerseyEnrollment38Cancer of Rectum
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Rwjbarnabas Health - Monmouth Medical Center

    Lakewood, New Jersey, United States

  • Rwjbarnabas Health - Saint Barnabas Medical Center, Livingston

    Livingston, New Jersey, United States

  • Rutgers, the State University of New Jersey

    New Brunswick, New Jersey, United States

  • Rwjbarnabas Health - Robert Wood Johnson University Hospital, Somerset

    Somerset, New Jersey, United States

  • Rwjbarnabas Health - Community Medical Center

    Toms River, New Jersey, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Combination of drugs + FOLFOXIRI
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
13 May 2022
Primary completion
30 Dec 2027
Completion
30 Jan 2028
Last update posted
4 Dec 2025
Registered enrollment
38
Registry id
NCT05358704
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.