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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.

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.

combination of drugs (chemoradiation (capecitabine and radiation) + FOLFOXIRI (Oxaliplatin, leucovorin, irinotecan, and fluorouracil)

Salma Jabbour, MD

Patrick M Boland, MD

.Salma Jabbour, MD

Patrick M Boland,, MD

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.

Treatment will continue until participants experiences disease progression, unacceptable toxicity or withdraws consent and will include chemoradiation (28 days) followed by FOLFOXIRI x 8 cycles (16 weeks). A cycle is defined as an interval of fourteen days, except for Cycle 1 spanning fourteen days which includes eight cycles of FOLFOXIRI treatment prior to surgery. For participants experiencing unacceptable FOLFOXIRI or chemoradiation related toxicity, yet obtaining therapeutic benefit, participants will be allowed to continue treatment, if well tolerated at the discretion of the investigator.

Upon discontinuation of study treatment, participants will receive safety follow-up assessments approximately 30 and 90 days later. Once the 90-day safety follow-up is complete, participants will enter the survival follow-up period where they will continue to be followed approximately every three months until death, withdrawal of consent, or overall study completion. Patients will be followed for survival for 36 months from enrollment.

A single arm, open label, multi-institutional, Phase II trial of chemoradiation (CRT) followed by FOLFOXIRI for T3/T4 or lymph node positive rectal adenocarcinoma using a total neoadjuvant therapy (TNT) approach.

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

Preoperative ChemoRadiation And FOLFOXIRI To Escalate Complete Response for Rectal Cancer (CRAFTER)

Measurable lesions are defined as those that can be accurately measured in at least one dimension. This guideline has defined measurability of lesions on Computed tomography (CT) scan based on the assumption that Computed tomography (CT) slice thickness is 5 mm or less. If Computed tomography (CT) scans have slice thickness greater than 5 mm, the minimum size for a measurable lesion should be twice the slice thickness each restaging time point.

Measurable lesions are defined as those that can be accurately measured in at least one dimension. Malignant lymph nodes to be considered pathologically enlarged and measurable, a lymph node must be \>15 mm in short axis when assessed by Computed tomography (CT) scan (CT scan slice thickness recommended to be no greater than 5 mm). At baseline and in follow-up, only the short axis will be measured and followed.

Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used for tumor measurements. Imaging for response assessment will be obtained before the initiation of conditioning (no more than four weeks prior to apheresis) and at the six-week follow up time point.

Standard tumor measurements using various scan studies. Scans are to be completed at each restaging time point. Participants will have cancer scan assessments every twelve weeks. Positron emission tomography (PET); Computed tomography (CT)can be used on this trial for response evaluation criteria in solid tumors (RECIST) measurements and can be used interchangeably with conventional Computed tomography (CT).

Standard tumor measurements using various scan studies. Scans are to be completed at each restaging time point.

Rutgers, The State University of New Jersey

Professor of Radiation Oncology and Vice Chair

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative ChemoRadiation And FOLFOXIRI for Rectal Cancer (CRAFTER) for Rectal Cancer	NCT05358704	Cancer of Rectu...	combination of ...	18 Years -	Rutgers, The State University of New Jersey
Preoperative ChemoRadiation And FOLFOXIRI for Rectal Cancer (CRAFTER) for Rectal Cancer	NCT05358704	Cancer of Rectu...	combination of ...	18 Years -	Rutgers, The State University of New Jersey
Preoperative ChemoRadiation And FOLFOXIRI for Rectal Cancer (CRAFTER) for Rectal Cancer	NCT05358704	Cancer of Rectu...	combination of ...	18 Years -	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for combination of drugs (chemoradiation (capecitabine and radiation) + folfoxiri (oxaliplatin, leucovorin, irinotecan, and fluorouracil)