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

NCT04643366 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: MCC-18-14260HM20020384NCI-2020-13796
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Rectal Cancer

Keywords

Resectable; Rectal

Outcome Measures

Primary Outcomes (1)

• Three-year disease free survival (DFS)

  The three-year disease free survival (DFS) defined as the number of patients alive without recurrence of disease at 3 years measured from the date of clinical complete response (cCR) or date of total mesorectal excision (TME) at surgery (whichever is earlier).

  3 years after end of treatment

Secondary Outcomes (6)

• Pathologic complete response (pCR) rate

  3 Years after end of treatment

• Clinical complete response (cCR) following total neoadjuvant therapy (TNT) based on tumor response

  3 Years after end of treatment

• The number of Adverse events (AEs) per participant

  39 Months

• Progression (PFS) Rate

  3 Years after end of treatment

• Overall Survival (OS) Rate

  3 Years after end of treatment

Study Arms (1)

Concurrent Chemotherapy/ Radiation Therapy

EXPERIMENTAL

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.

Drug: Chemotherapy; Radiation: Radiation Therapy

Interventions

Chemotherapy DRUG

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

Concurrent Chemotherapy/ Radiation Therapy

Radiation Therapy RADIATION

Pelvic Intensity-modulated radiation therapy (IMRT)

Concurrent Chemotherapy/ Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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)

You may not qualify 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 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (3)

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

RECRUITING

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

VCU Community Memorial Healthcenter

South Hill, Virginia, 23970, United States

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Khalid Matin, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massey IIT Research Operations, RN

CONTACT

804-628-6430; masseyepd@vcu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 25, 2020
• Study Start: January 28, 2021
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2033
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)