RECRUITING

Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable 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

This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.

Official Title

Phase 2 Study of Total Neoadjuvant mFOLFOX and Short-Course Radiotherapy in Resectable Rectal Cancer

Quick Facts

Study Start:2021-01-28

Study Completion:2033-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04643366

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
* Pathologic diagnosis of adenocarcinoma of the rectum (diagnosis by tissue biopsy) within 90 days prior to registration. At least a portion of the tumor must be located below the peritoneal reflection or begin within 12 cm of the anal verge on flexible endoscopy * Clinically staged (AJCC 8th ed.) T3-4 N0 M0 or T any N1-2 M0 based upon the following minimum diagnostic workup: * Colonoscopy, unless patient presents with an obstructing lesion * Within 30 days prior to registration: * History/physical examination * Imaging to exclude distant metastases: either contrast-enhanced CT of the chest, abdomen, and pelvis or whole-body PET-CT or MRI * Pelvic MRI (preferred) or transrectal ultrasound (TRUS) for T staging * ECOG Performance Status ≤1 * Age ≥ 18 years * 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 liver and renal function defined as follows: * AST and alkaline phosphatase \< 2.5 x upper limit of normal (ULN) * Bilirubin ≤ 2.5 ULN * Calculated creatinine clearance (CrCl) \> 30 mL/min using Cockcroft-Gault formula as calculated by the standard Cockcroft-Gault equation using age, actual weight, creatinine, and gender * Must be deemed a candidate for curative resection by the surgical oncologist who will be performing the operation * Women of childbearing potential (WCBP) must have a negative serum pregnancy test performed within 7 days prior to the start of chemotherapy. * WCBP and men must agree to use a medically accepted form of birth control during the treatment and for 3 months following completion of chemotherapy. * Ability to understand and the willingness to sign a written informed consent document.	* Prior RT that would result in overlap of RT fields with the planned study treatment * Clinically significant cardiac disease, including major cardiac dysfunction, that in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin. * Serious (ie, ≥ grade 3) uncontrolled infection * Pulmonary or respiratory condition that, in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin. * Major surgery within 28 days of study enrollment (other than diverting colostomy) * History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis) requiring significant intervention (eg, hospitalization, surgery, immunosuppressive medications) that would, in the opinion of the investigator, preclude study therapy * Prior known allergic reaction to 5-fluorouracil, leucovorin, or oxaliplatin * Known dipyrimidine dehydrogenase deficiency (DPD) * Any evidence of distant metastases (M1) * Pregnant or breast feeding * Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Inclusion Criteria

Exclusion Criteria

* Pathologic diagnosis of adenocarcinoma of the rectum (diagnosis by tissue biopsy) within 90 days prior to registration. At least a portion of the tumor must be located below the peritoneal reflection or begin within 12 cm of the anal verge on flexible endoscopy
* Clinically staged (AJCC 8th ed.) T3-4 N0 M0 or T any N1-2 M0 based upon the following minimum diagnostic workup:
* Colonoscopy, unless patient presents with an obstructing lesion
* Within 30 days prior to registration:
* History/physical examination
* Imaging to exclude distant metastases: either contrast-enhanced CT of the chest, abdomen, and pelvis or whole-body PET-CT or MRI
* Pelvic MRI (preferred) or transrectal ultrasound (TRUS) for T staging
* ECOG Performance Status ≤1
* Age ≥ 18 years
* 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 liver and renal function defined as follows:
* AST and alkaline phosphatase \< 2.5 x upper limit of normal (ULN)
* Bilirubin ≤ 2.5 ULN
* Calculated creatinine clearance (CrCl) \> 30 mL/min using Cockcroft-Gault formula as calculated by the standard Cockcroft-Gault equation using age, actual weight, creatinine, and gender
* Must be deemed a candidate for curative resection by the surgical oncologist who will be performing the operation
* Women of childbearing potential (WCBP) must have a negative serum pregnancy test performed within 7 days prior to the start of chemotherapy.
* WCBP and men must agree to use a medically accepted form of birth control during the treatment and for 3 months following completion of chemotherapy.
* Ability to understand and the willingness to sign a written informed consent document.

* Prior RT that would result in overlap of RT fields with the planned study treatment
* Clinically significant cardiac disease, including major cardiac dysfunction, that in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.
* Serious (ie, ≥ grade 3) uncontrolled infection
* Pulmonary or respiratory condition that, in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.
* Major surgery within 28 days of study enrollment (other than diverting colostomy)
* History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis) requiring significant intervention (eg, hospitalization, surgery, immunosuppressive medications) that would, in the opinion of the investigator, preclude study therapy
* Prior known allergic reaction to 5-fluorouracil, leucovorin, or oxaliplatin
* Known dipyrimidine dehydrogenase deficiency (DPD)
* Any evidence of distant metastases (M1)
* Pregnant or breast feeding
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Contacts and Locations

Study Contact

Alison Ryan, NP

CONTACT

804-628-1936

ryanaa@vcu.edu

Massey CTO Operations Managers

CONTACT

ctoclinops@vcu.edu

Principal Investigator

Khalid Matin, MD

PRINCIPAL_INVESTIGATOR

Massey Cancer Center

Study Locations (Sites)

Virginia Cancer Institute

Richmond, Virginia, 23230

United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298

United States

VCU Community Memorial Healthcenter

South Hill, Virginia, 23970

United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

Khalid Matin, MD, PRINCIPAL_INVESTIGATOR, Massey Cancer Center

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 Date2021-01-28

Study Completion Date2033-01-31

Study Record Updates

Study Start Date2021-01-28

Study Completion Date2033-01-31

Terms related to this study

Keywords Provided by Researchers

Resectable
Rectal

Additional Relevant MeSH Terms

Rectal Cancer