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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT04643366
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy — DRUG
    Neoadjuvant chemotherapy with 2 months of combination oxaliplatin and 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX)
  • Radiation Therapy — RADIATION
    Pelvic Intensity-modulated radiation therapy (IMRT)

Study Details

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

Key Dates

Start date
Jan 28, 2021
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2033

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Concurrent Chemotherapy/ Radiation Therapy
    5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) four 14-day cycles will be given before CRT starts. Pelvic Intensity-modulated radiation therapy (IMRT): 25 Gy in 5 fractions over 5 days + Continuous infusion 5-fluorouracil (5-FU) for 4 days (96 hours) followed by four 14-day cycles of (mFOLFOX6) to be given after CRT ends.

Primary Outcome Measure

Three-year disease free survival (DFS) [ Time Frame: 3 years after end of treatment ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Virginia Cancer InstituteRichmondVirginia23230
Sue Moore, MSN, RN
[email protected]
804-287-3000
Purvi Shah, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298
Massey CTO GI Team, RN
[email protected]
804-628-6430
Khalid Matin, MD (PRINCIPAL_INVESTIGATOR)
VCU Community Memorial HealthcenterSouth HillVirginia23970
Massey CTO GI Team
[email protected]
804-628-6430
Khalid Matin, MD (PRINCIPAL_INVESTIGATOR)
VCU Health Tappahannock HospitalTappahannockVirginia22560
Massey CTO GI Team
[email protected]
804-628-6430
Khalid Matin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Richmond, VA

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By research site
Virginia Cancer Institute· Richmond, VAVirginia Commonwealth University Massey Cancer Center· Richmond, VAVCU Community Memorial Healthcenter· South Hill, VAVCU Health Tappahannock Hospital· Tappahannock, VA

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