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Anti-metabolites

Chemotherapy + Radiation for Rectal Cancer

Phase 2
Recruiting
Led By Khalid Matin, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG Performance Status ≤1
Clinically staged T3-4 N0 M0 or T any N1-2 M0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years after end of treatment
Awards & highlights

Study Summary

This trial is testing a new way to treat rectal cancer that may be less intense and have fewer side effects.

Who is the study for?
This trial is for adults with resectable rectal cancer, without distant metastases. Participants must have adequate organ function and no serious recent illnesses or surgeries. They should not be pregnant or breastfeeding and must agree to use birth control during the study.Check my eligibility
What is being tested?
The trial tests a combination of chemotherapy (mFOLFOX) and short-course radiation therapy as initial treatment before surgery in patients with rectal cancer. It's designed to see if this approach is effective in treating the disease.See study design
What are the potential side effects?
Possible side effects include reactions to chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk, liver issues, nerve damage from oxaliplatin, and skin irritation from radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all pre-disease activities without restriction.
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My cancer is in an advanced local stage but hasn't spread to distant parts.
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I was diagnosed with rectal cancer in the last 3 months.
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I am 18 years old or older.
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I've had a recent scan to check for cancer spread.
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I agree to use birth control during and for 3 months after treatment.
Select...
My surgeon believes surgery could potentially cure my cancer.
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My liver and kidney tests are within normal ranges.
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I've had a pelvic MRI or ultrasound for cancer staging within the last 28 days.
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My blood tests show enough white cells, platelets, and hemoglobin.
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Part of my tumor is located in the lower part of my abdomen or within 12 cm of my anus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years after end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years after end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Three-year disease free survival (DFS)
Secondary outcome measures
Neoplasms
Number of patients who do not require an ostomy at time of surgery
Overall Survival (OS) Rate
+3 more

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531
29%
Nausea
19%
Leukopenia
14%
Anaemia
14%
Neutropenia
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
14%
Vomiting
14%
White blood cell count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
10%
Neutrophil count decreased
5%
Diarrhea
5%
Musculoskeletal pain
5%
Dizziness
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Concurrent Chemotherapy/ Radiation TherapyExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
691 Previous Clinical Trials
22,884,699 Total Patients Enrolled
Khalid Matin, MDPrincipal InvestigatorMassey Cancer Center

Media Library

mFOLFOX (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04643366 — Phase 2
Colorectal Cancer Research Study Groups: Concurrent Chemotherapy/ Radiation Therapy
Colorectal Cancer Clinical Trial 2023: mFOLFOX Highlights & Side Effects. Trial Name: NCT04643366 — Phase 2
mFOLFOX (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04643366 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the risks associated with Chemotherapy?

"Chemotherapy's safety is estimated to be a 2. This drug is in Phase 2 of clinical trials, which suggests that while there is evidence of its safety, there is currently no data supporting Chemotherapy's efficacy."

Answered by AI

Are there any open spots for volunteers in this experiment?

"The trial, which can be found on clinicaltrials.gov, is actively recruiting patients at this time. This study was first posted on 1/28/2021 and has been edited most recently on 10/26/2022."

Answered by AI
~30 spots leftby Jan 2028