SUSPENDED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-13

Study Completion:2028-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT05358704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * 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:	* 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: * 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

Inclusion Criteria

Exclusion 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:
* 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:

* 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:
* 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

Contacts and Locations

Principal Investigator

Salma Jabbour, MD

PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Patrick M Boland, MD

PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Study Locations (Sites)

RWJBarnabas Health - Monmouth Medical Center

Lakewood, New Jersey, 08701

United States

RWJBarnabas Health - Saint Barnabas Medical Center, Livingston

Livingston, New Jersey, 07039

United States

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, 08901

United States

RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset

Somerset, New Jersey, 08873

United States

RWJBarnabas Health - Community Medical Center

Toms River, New Jersey, 08755

United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Salma Jabbour, MD, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute of New Jersey
Patrick M Boland, MD, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-13

Study Completion Date2028-01-30

Study Record Updates

Study Start Date2022-05-13

Study Completion Date2028-01-30

Terms related to this study

Keywords Provided by Researchers

Cancer of Rectum

Additional Relevant MeSH Terms

Cancer of Rectum