Neoadjuvant therapy and radiation for rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial evaluates the effectiveness of a treatment regimen combining four cycles of systemic chemotherapy with short-course radiation therapy for patients with resectable rectal cancer. Participants will receive concurrent 5-FU neoadjuvant chemoradiotherapy followed by additional chemotherapy cycles before surgery. The study aims to assess three-year disease-free survival rates, focusing on patients who achieve a clinical complete response or undergo total mesorectal excision. The trial seeks to determine the optimal approach to improve outcomes for rectal cancer patients.

Why it matters

Who can join: the full rules

Inclusion 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 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 treatment and can feasibly continue to CRT according to the timeline described in Section
* 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.

Exclusion Criteria:

* 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 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

Where it's running

• Virginia Cancer Institute
  Richmond, Virginia, United States Recruiting
• Virginia Commonwealth University Massey Cancer Center
  Richmond, Virginia, United States Recruiting
• VCU Community Memorial Healthcenter
  South Hill, Virginia, United States Recruiting
• VCU Health Tappahannock Hospital
  Tappahannock, Virginia, United States Not yet recruiting

Study contacts

• Principal investigator: Khalid Matin, MD — Massey Cancer Center
• Study coordinator: Massey IIT Research Operations, RN
• Email: masseyepd@vcu.edu
• Phone: 804-628-6430

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Single vs. double stapling and purse-string techniques after rectal cancer surgery

  This trial tests whether using a single-stapling method to join the bowel after rectal cancer surgery results in fewer leaks compared with the double-stapling method.

  Recruiting Alexandria University · Alexandria · NCT07929415

• DEM301 in advanced colorectal cancer: a first-in-human test

  This first-in-human Phase 1 study tests DEM301 in adults with advanced metastatic colorectal cancer to see if it is safe, how it behaves in the body, and whether it shows any signs of activity.

  Recruiting at 2 sites Phase 1 DEM BioPharma, Inc. · Birtinya, Queensland and 1 other locations · NCT07805369

• Rectal cancer registry to track real-world treatments and outcomes

  This registry collects real-world data on how locally advanced rectal cancer is treated in Austria, to see how TNT and dMMR/MSI-H cases are managed and what outcomes occur.

  Recruiting at 2 sites Austrian Breast & Colorectal Cancer Study Group · Wiener Neustadt, Lower Austria and 5 other locations · NCT07780305

• Aerobic exercise and guided imagery for bowel problems after rectal cancer surgery

  This study tests whether a program of aerobic exercise plus guided imagery helps people with low anterior resection syndrome after rectal cancer surgery.

  Recruiting Biruni University · Istanbul · NCT07732894

• Active surveillance vs chemoradiotherapy after local removal of intermediate-risk T1 rectal cancer

  This study tests whether close follow-up alone after local removal of early rectal cancer can match the cancer control of adding chemoradiotherapy, while reducing treatment-related side effects.

  Recruiting at 2 sites Medical University of Gdansk · Limoges and 2 other locations · NCT07669298

• Different-Dose Short-Course Radiotherapy With CAPOX, PD-1 Blockade, and IL-2 in Locally Advanced Rectal Cancer

  This phase II trial tests whether a low-dose short-course radiotherapy combined with CAPOX, a PD-1 blocker, and IL-2 works as well as the standard-dose short-course approach in patients with locally advanced rectal cancer.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07646639

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.