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Anti-metabolites

FOLFOX Chemotherapy for Rectal Cancer

Phase 2
Waitlist Available
Led By Richard Dunne
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No active infections requiring intravenous antibiotics
Women of childbearing potential (WCBP) will be defined as those biologically capable of becoming pregnant. WCBP must be negative for pregnancy testing (urine or blood) and agree to use effective contraception. Viable contraception should be used after trial screening, before initiation of chemotherapy, and throughout the duration of active treatment in the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing whether patients with locally advanced rectal cancer can be treated with chemotherapy alone, without radiation or surgery.

Who is the study for?
Adults diagnosed with locally advanced rectal cancer who haven't had previous treatments or radiation, and have no history of other cancers in the last 3 years. They must meet specific blood work criteria, not be pregnant or planning to conceive, and agree to use contraception. Those with certain heart conditions, active infections, or peripheral neuropathy are excluded.Check my eligibility
What is being tested?
The trial is testing FOLFOX chemotherapy without radiation and surgery for complete response in treating locally advanced rectal cancer. It aims to see if patients can achieve remission with this approach alone.See study design
What are the potential side effects?
FOLFOX may cause side effects like fatigue, nausea, diarrhea, low blood cell counts increasing infection risk; nerve damage that could lead to tingling or numbness; allergic reactions; and liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any infections needing IV antibiotics.
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I can become pregnant and agree to use effective birth control during the study.
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My cancer has not spread to other parts of my body.
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My rectal cancer likely needs a specific type of surgery.
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I do not have any other active cancer.
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I have lower rectal cancer and cannot have surgery to save the sphincter.
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My cancer is a type of rectal cancer confirmed by a biopsy.
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I have never been treated with platinum-based chemotherapy.
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My cancer is at a specific stage, not the most advanced.
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I have not received any treatment for my rectal cancer.
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I haven't been treated for any cancer in the last 3 years.
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I have never received radiation therapy to my pelvic area.
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I was over 18 when I was diagnosed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Patients With a Complete Clinical Response.
Secondary outcome measures
Proportion of Patients With Survival

Side effects data

From 2020 Phase 3 trial • 567 Patients • NCT02923921
45%
Nausea
38%
Anaemia
38%
Fatigue
36%
Thrombocytopenia
35%
Decreased appetite
29%
Abdominal pain
29%
Vomiting
28%
Constipation
27%
Asthenia
25%
Diarrhoea
21%
Neutropenia
21%
Platelet count decreased
20%
Pyrexia
17%
Neutrophil count decreased
15%
Oedema peripheral
14%
Neuropathy peripheral
13%
Back pain
11%
Dyspnoea
11%
Peripheral sensory neuropathy
10%
Ascites
10%
Stomatitis
9%
Paraesthesia
8%
Rash
8%
Hypokalaemia
8%
Dyspepsia
8%
Blood alkaline phosphatase increased
7%
Dizziness
7%
Hypoalbuminaemia
7%
Abdominal pain upper
7%
Blood bilirubin increased
7%
Dysgeusia
6%
Cough
6%
Injection site erythema
6%
Abdominal distension
6%
Headache
5%
Hyperglycaemia
5%
Weight decreased
5%
Pruritus
5%
Flatulence
5%
Neurotoxicity
5%
Insomnia
4%
Dehydration
4%
Hyponatraemia
4%
Sepsis
4%
Aspartate aminotransferase increased
3%
Pneumonia
3%
Polyneuropathy
2%
Cholangitis
1%
General physical health deterioration
1%
Angina pectoris
1%
Cholangitis acute
1%
Colitis
1%
Small intestinal obstruction
1%
Jaundice cholestatic
1%
Bacteraemia
1%
Septic shock
1%
Acute kidney injury
1%
Prostatic obstruction
1%
Pleural effusion
1%
Device occlusion
1%
Biliary tract infection
1%
Clostridium difficile colitis
1%
Device related infection
1%
Hip fracture
1%
Pneumonitis
1%
Pulmonary embolism
1%
Gastrointestinal haemorrhage
1%
Febrile neutropenia
1%
Embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pegilodecakin + FOLFOX
FOLFOX

Trial Design

1Treatment groups
Experimental Treatment
Group I: mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin)Experimental Treatment1 Intervention
Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle. Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFOX
2009
Completed Phase 3
~4560

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
833 Previous Clinical Trials
518,132 Total Patients Enrolled
Richard Dunne5.01 ReviewsPrincipal Investigator - University of Rochester
University of Rochester
3 Previous Clinical Trials
93 Total Patients Enrolled

Media Library

FOLFOX (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03781323 — Phase 2
Rectal Cancer Research Study Groups: mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin)
Rectal Cancer Clinical Trial 2023: FOLFOX Highlights & Side Effects. Trial Name: NCT03781323 — Phase 2
FOLFOX (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03781323 — Phase 2

Frequently Asked Questions

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

Has the FOLFOX regimen been cleared by the FDA?

"FOLFOX's safety is supported by some data, but not to the same extent as a Phase 3 trial. Therefore, it received a score of 2."

Answered by AI

Can new patients still join this clinical trial?

"Unfortunately, this trial is no longer seeking patients. The listing for this study was first posted on May 3rd 2019 but was edited most recently on June 9th, 2022. However, there are 321 other trials recruiting cancer of the rectum patients and 564 FOLFOX trials that still need participants."

Answered by AI

To what medical conditions is FOLFOX most often given as a treatment?

"FOLFOX is a standard treatment for advanced esophageal cancers, but it has also been used to ameliorate other conditions like stage iii colon cancer and advanced gastric cancer."

Answered by AI

How many people have been recruited for this research project?

"This research project is not looking for participants at the moment. The trial was initially posted on May 3rd, 2019 and updated last on June 9th, 2022. If you are interested in other studies, 321 trials related to cancer of the rectum are currently admitting patients and 564 studies involving FOLFOX are actively searching for candidates."

Answered by AI

What other steps have been taken to study FOLFOX?

"At this moment, there are 564 active clinical trials investigating FOLFOX with 194 in Phase 3. While a portion of these research studies are based in Woolloongabba, Queensland, 25836 other sites around the world are also studying FOLFOX."

Answered by AI
~2 spots leftby Mar 2025