RecruitingPhase 2NCT04643366

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

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


Sponsor

Virginia Commonwealth University

Enrollment

54 participants

Start Date

Jan 28, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a total neoadjuvant therapy (TNT) approach for rectal cancer — where patients receive both chemotherapy (mFOLFOX) and short-course radiation therapy before surgery, rather than splitting treatment before and after. The goal is to shrink the tumor as much as possible before surgery and potentially improve long-term outcomes. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of rectal adenocarcinoma (cancer confirmed by tissue biopsy) - Your cancer is Stage T3–T4 or involves lymph nodes (N1–N2) but has not spread to distant organs (M0) - Your tumor is in the lower part of the rectum (within 12 cm of the anal opening or below the peritoneal fold) - Your blood counts, liver, and kidney function are in acceptable ranges - Your general health is good enough for treatment (ECOG ≤ 2) **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have had prior radiation to the pelvis - Your blood counts or organ function are significantly impaired - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChemotherapy

Neoadjuvant chemotherapy with 2 months of combination oxaliplatin and 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX)

RADIATIONRadiation Therapy

Pelvic Intensity-modulated radiation therapy (IMRT)


Locations(4)

Virginia Cancer Institute

Richmond, Virginia, United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

VCU Community Memorial Healthcenter

South Hill, Virginia, United States

VCU Health Tappahannock Hospital

Tappahannock, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT04643366


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