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

Part of paid clinical trials in Lakewood, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05358704
Phase
PHASE2
Status
Suspended

Conditions

  • Cancer of Rectum

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • combination of drugs (chemoradiation (capecitabine and radiation) + FOLFOXIRI (Oxaliplatin, leucovorin, irinotecan, and fluorouracil) — DRUG
    To evaluate the safety and preliminary efficacy of Preoperative ChemoRadiation and FOLFOXIRI To Escalate Complete Response for Rectal Cancer patients. receive the experimental combination of drugs (chemoradiation (capecitabine and radiation) + FOLFOXIRI (Oxaliplatin, leucovorin, irinotecan, and fluorouracil) 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.

Study Details

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.

Key Dates

Start date
May 13, 2022
Status verified
Nov 2025
Primary completion
Dec 30, 2027
Completion
Jan 30, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of drugs prior to surgery
    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 - six hours during pre-study, study and end of study visits.

Primary Outcome Measure

Positron emission tomography (PET) [ Time Frame: Four Years ]

Locations (5)

FacilityCityStateZIPSite coordinators
RWJBarnabas Health - Monmouth Medical CenterLakewoodNew Jersey08701-
RWJBarnabas Health - Saint Barnabas Medical Center, LivingstonLivingstonNew Jersey07039-
Rutgers, The State University of New JerseyNew BrunswickNew Jersey08901-
RWJBarnabas Health - Robert Wood Johnson University Hospital, SomersetSomersetNew Jersey08873-
RWJBarnabas Health - Community Medical CenterToms RiverNew Jersey08755-

Find similar trials in Lakewood, NJ

By research site
RWJBarnabas Health - Monmouth Medical Center· Lakewood, NJRWJBarnabas Health - Saint Barnabas Medical Center, Livingston· Livingston, NJRutgers, The State University of New Jersey· New Brunswick, NJRWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset· Somerset, NJRWJBarnabas Health - Community Medical Center· Toms River, NJ

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