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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

There must be no evidence of metastatic disease any time prior to initiation of study

Must not have

Patients with cardiovascular, hepatic, or renal systemic diseases that would preclude use of chemotherapy

T1N0, T2N0, T4a, T4b, or N2b tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have heart, liver, or kidney diseases that would prevent me from receiving chemotherapy.

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My cancer is at a specific stage and size.

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I do not have severe numbness or pain in my hands or feet.

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My cancer is very close to the edge of the tissue removed during surgery.

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I plan to have children in the future.

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My cancer has spread to other parts of my body.

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My rectal cancer cannot be surgically removed due to its spread to nearby organs.

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My rectal cancer has come back or is not responding to treatment.

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I have had a heart attack, stroke, or similar event in the last 6 months.

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I am not currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Patients With a Complete Clinical Response.

Secondary study objectives

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%

Peripheral sensory neuropathy

11%

Dyspnoea

10%

Ascites

10%

Stomatitis

Paraesthesia

Hypokalaemia

Dyspepsia

Blood alkaline phosphatase increased

Rash

Hypoalbuminaemia

Abdominal pain upper

Blood bilirubin increased

Dizziness

Dysgeusia

Abdominal distension

Injection site erythema

Cough

Headache

Hyperglycaemia

Flatulence

Weight decreased

Neurotoxicity

Insomnia

Pruritus

Aspartate aminotransferase increased

Sepsis

Dehydration

Hyponatraemia

Pneumonia

Polyneuropathy

Cholangitis

Colitis

Device occlusion

Angina pectoris

Small intestinal obstruction

General physical health deterioration

Cholangitis acute

Jaundice cholestatic

Bacteraemia

Biliary tract infection

Clostridium difficile colitis

Device related infection

Septic shock

Hip fracture

Acute kidney injury

Prostatic obstruction

Pleural effusion

Pneumonitis

Pulmonary embolism

Gastrointestinal haemorrhage

Febrile neutropenia

Embolism

100%

80%

60%

40%

20%

Study treatment Arm

Pegilodecakin + FOLFOX

FOLFOX

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 22Eligibility criteria met