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

Primary Purpose

Cancer of Rectum

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
combination of drugs (chemoradiation (capecitabine and radiation) + FOLFOXIRI (Oxaliplatin, leucovorin, irinotecan, and fluorouracil)
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Rectum focused on measuring Cancer of Rectum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)
  • Adequate hepatic function within within 28 days before registration on this study:

total bilirubin must be ≤ ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and AST and ALT must be ≤3 x ULN for the lab If AST and/or ALT is ≥ ULN but ≤ 3 x ULN, serologic testing for Hepatitis B and C must be performed and results for viral infection must be negative

  • Adequate renal function within 28 days before randomization defined as serum creatinine ≤ 1.5 x ULN for the lab or calculated creatinine clearance > 30 mL/min
  • International normalized ratio of prothrombin time (INR) within 28 days before randomization must be ≤ ULN for the lab. Patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history
  • Acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease must:

Have a CD4 count ≥ 200 cells/μL within 30 days before randomization Be on a stable regimen of antiretroviral therapy Have no evidence of opportunistic infection

Exclusion Criteria:

  • 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

Sites / Locations

  • RWJBarnabas Health - Monmouth Medical CenterRecruiting
  • RWJBarnabas Health - Saint Barnabas Medical Center, LivingstonRecruiting
  • Rutgers, The State University of New JerseyRecruiting
  • RWJBarnabas Health - Robert Wood Johnson University Hospital, SomersetRecruiting
  • RWJBarnabas Health - Community Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination of drugs prior to surgery

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Magnetic resonance imaging (MRI)
Standard tumor measurements using various scan studies. Scans are to be completed at each restaging time point.

Full Information

First Posted
April 28, 2022
Last Updated
September 17, 2023
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT05358704
Brief Title
Preoperative ChemoRadiation And FOLFOXIRI for Rectal Cancer (CRAFTER) for Rectal Cancer
Official Title
Preoperative ChemoRadiation And FOLFOXIRI To Escalate Complete Response for Rectal Cancer (CRAFTER)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Rectum
Keywords
Cancer of Rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination of drugs prior to surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
combination of drugs (chemoradiation (capecitabine and radiation) + FOLFOXIRI (Oxaliplatin, leucovorin, irinotecan, and fluorouracil)
Other Intervention Name(s)
prior to surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positron emission tomography (PET)
Description
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).
Time Frame
Four Years
Secondary Outcome Measure Information:
Title
Magnetic resonance imaging (MRI)
Description
Standard tumor measurements using various scan studies. Scans are to be completed at each restaging time point.
Time Frame
Four Years
Other Pre-specified Outcome Measures:
Title
Computed tomography (CT) Scan of Chest, Abdomen and Pelvis (CT C/A/P)
Description
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.
Time Frame
Four Years
Title
Computed tomography (CT)
Description
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.
Time Frame
Four Years
Title
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Description
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.
Time Frame
Four Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Adequate hepatic function within within 28 days before registration on this study: total bilirubin must be ≤ ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and AST and ALT must be ≤3 x ULN for the lab If AST and/or ALT is ≥ ULN but ≤ 3 x ULN, serologic testing for Hepatitis B and C must be performed and results for viral infection must be negative Adequate renal function within 28 days before randomization defined as serum creatinine ≤ 1.5 x ULN for the lab or calculated creatinine clearance > 30 mL/min International normalized ratio of prothrombin time (INR) within 28 days before randomization must be ≤ ULN for the lab. Patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history Acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease must: Have a CD4 count ≥ 200 cells/μL within 30 days before randomization Be on a stable regimen of antiretroviral therapy Have no evidence of opportunistic infection Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salma Jabbour, MD
Phone
(732) 253-3939
Email
jabbousk@cinj.rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick M Boland, MD
Phone
(732)235-2465
Email
pb564@cinj.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salma Jabbour, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick M Boland, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
RWJBarnabas Health - Monmouth Medical Center
City
Lakewood
State/Province
New Jersey
ZIP/Postal Code
08701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salma Jabbour, MD
Facility Name
RWJBarnabas Health - Saint Barnabas Medical Center, Livingston
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salma Jabbour, MD
Facility Name
Rutgers, The State University of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
.Salma Jabbour, MD
Phone
732-253-3939
Email
jabbousk@cinj.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Patrick M Boland,, MD
Phone
(732)235-2465
Email
pb564@cinj.rutgers.edu
Facility Name
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salma Jabbour, MD
Facility Name
RWJBarnabas Health - Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salma Jabbour, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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