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

NCT05358704 | Suspended Phase 2 DMC FDA Drug

• 2 other identifiers: 072202Pro2022000098
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Cancer of Rectum

Keywords

Cancer of Rectum

Outcome Measures

Primary Outcomes (1)

• Positron emission tomography (PET)

  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).

  Four Years

Secondary Outcomes (1)

• Magnetic resonance imaging (MRI)

  Four Years

Other Outcomes (3)

• Computed tomography (CT) Scan of Chest, Abdomen and Pelvis (CT C/A/P)

  Four Years

• Computed tomography (CT)

  Four Years

• Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

  Four Years

Study Arms (1)

Combination of drugs prior to surgery

EXPERIMENTAL

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.

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

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.

Also known as: prior to surgery

Combination of drugs prior to surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent for the trial
• Age 18 years or greater
• Be fully active, able to carry on all pre-disease performance without restriction or Restricted in physically strenuous activity but able to carry out work of a light or sedentary nature (e.g., light house work, office work)
• Pathologically proven diagnosis of adenocarcinoma of the rectum (located up to 15 cm from the anal verge). Diagnosis of rectal adenocarcinoma must be obtained by biopsy technique that does not completely excise the lesion (e.g., fine needle aspiration, core needle biopsy)
• Clinically determined to be stage T3 or T4, N0-N2, and M0
• Contrast-enhanced imaging of the abdomen by CT; MRI rectal protocol; Chest x-ray (or CT) of the chest All within 56 days prior to registration to exclude distant metastases and provide local tumor stage
• Adequate bone marrow function
• Adequate renal and liver function
• No active second cancers
• Be willing and able to comply with all aspects of the protocol
• Female patients of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication
• Female patients of childbearing potential should be willing to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
• Male patients should agree to abstinence or use of an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
• Zubrod Performance Status 0-2
• CBC/differential obtained within 28 days prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,200 cells/mm3 Platelets ≥ 100,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable)

You may not qualify if:

• Age less than 18 years
• Pregnant or breastfeeding women
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of three years
• Prior systemic chemotherapy for colorectal cancer; note that prior chemotherapy for a different cancer is allowed.
• Prior radiotherapy to the region of your present study cancer that would result in overlap of radiation therapy fields
• Severe, active comorbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last twelve months Transmural myocardial infarction within the last six months Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake Known, existing uncontrolled coagulopathy. Patients on therapeutic anticoagulation may be enrolled provided that they have been clinically stable on anti-coagulation for at least two weeks
• Evidence of grade two or greater peripheral neuropathy
• Major surgery within 28 days of study enrollment
• Prior allergic reaction to oxaliplatin or capecitabine
• Any evidence of distant metastases
• A synchronous primary colon carcinoma
• Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn's disease that results in malabsorption; significant bowel resection that would make one concerned about the absorption of capecitabine) or malabsorption syndrome that would preclude feasibility of oral chemotherapy (capecitabine)
• Participation in any investigational drug study within 28 days of study enrollment

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (5)

RWJBarnabas Health - Monmouth Medical Center

Lakewood, New Jersey, 08701, United States

Location

RWJBarnabas Health - Saint Barnabas Medical Center, Livingston

Livingston, New Jersey, 07039, United States

Location

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset

Somerset, New Jersey, 08873, United States

Location

RWJBarnabas Health - Community Medical Center

Toms River, New Jersey, 08755, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Chemoradiotherapy; Capecitabine; Radiation; Oxaliplatin; Leucovorin; Irinotecan; Fluorouracil

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Physical Phenomena; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids

Study Officials

• Salma Jabbour, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

• Patrick M Boland, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiation Oncology and Vice Chair

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 3, 2022
• Study Start: May 13, 2022
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)