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New treatment option for Rectal Cancer
Official title Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer
ClinicalTrials.gov ID: NCT04643366
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, being studied as a potential treatment for rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologic diagnosis of adenocarcinoma of the rectum (diagnosis by tissue biopsy) within 90 days prior to registration. At least a portion of the...
- 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 before initiating MFOLFOX6 treatment:
- History/physical examination
You likely can't join if
- Prior RT that would result in unsafe overlap of RT fields with the planned study treatment, per the treating radiation oncologist
- Clinically significant cardiac disease, including major cardiac dysfunction, that in the opinion of the treating medical oncologist would preclude...
- 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...
- 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...
See the full eligibility 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...
- 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 before initiating MFOLFOX6 treatment:
- 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 Note: Patients may have initiated standard mFOLFOX6 treatment before study registration provided that they met the above criteria before initiating...
- ECOG Performance Status ≤2
- 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 unsafe overlap of RT fields with the planned study treatment, per the treating radiation oncologist
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
- South Hill, Virginia, United States
- Tappahannock, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States; South Hill, Virginia, United States; Tappahannock, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.