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Chemotherapy

Radiation + Chemotherapy for Rectal Cancer (NOM-ERA Trial)

N/A

Recruiting

Led By Hyun Kim, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

At least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

NOM-ERA Trial Summary

This trial is testing a new treatment for rectal cancer that involves a short course of radiation therapy followed by chemotherapy. So far, the treatment has shown a promising response rate of 74%.

Who is the study for?

This trial is for adults with stage I-IIIB non-metastatic rectal adenocarcinoma, confirmed by biopsy and MRI. Participants must have an ECOG performance status of 0-2, adequate blood cell counts, a detectable tumor not more than 12 cm from the anal verge, and agree to use contraception if applicable. Exclusions include prior treatments for rectal cancer, other recent malignancies (except certain skin cancers), uncontrolled illnesses like heart failure or infection, HIV with low CD4+ count or recent opportunistic infections.Check my eligibility

What is being tested?

The study tests short course radiation therapy followed by FOLFOX chemotherapy in patients with rectal cancer who are not undergoing surgery. The goal is to validate the complete clinical response rate observed in earlier research. Patients' responses will be monitored using biopsies, blood tests for circulating tumor DNA (ctDNA), and quality-of-life assessments through the FACT-C questionnaire.See study design

What are the potential side effects?

Potential side effects may include those common to radiation therapy such as fatigue, skin changes at the treatment site, gastrointestinal discomfort; and those related to FOLFOX chemotherapy including nausea, neuropathy (nerve issues), low blood cell counts increasing infection risk and bleeding tendency.

NOM-ERA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

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My rectal cancer is in an early to mid-stage, confirmed by a biopsy and MRI.

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My tumor can be seen or felt through medical exams.

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My tumor is within 12 cm of the anal opening, confirmed by MRI or endoscopy.

NOM-ERA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Clinical complete response rate

Secondary outcome measures

Incidence of grade 3 or higher toxicity during treatment

Incidence of post chemoradiotherapy grade 3 or higher toxicity

Organ preservation rate

+2 more

Side effects data

From 2013 Phase 3 trial • 397 Patients • NCT00004054

78%

Menopausal symptoms

60%

Urinary frequency

52%

Impotence

47%

Late RT Toxicity: Bladder: NOS

39%

Diarrhea NOS

27%

Late RT Toxicity: Bowel: NOS

26%

Fatigue

26%

Late RT Toxicity: Other GU: NOS

21%

Proctitis NOS

21%

Dysuria

14%

Libido decreased

14%

Dermatitis radiation NOS

12%

Late RT Toxicity: Other GI: NOS

12%

Late RT Toxicity: Other: NOS

12%

Hemoglobin decreased

12%

Alanine aminotransferase increased

Gynaecomastia

Urinary retention

Pain-other

Aspartate aminotransferase increased

Rectal bleeding

Constipation

Leukopenia NOS

Edema NOS

Hematuria present

Renal/GU-Other

Arthralgia

Blood creatinine increased

Dyspnea NOS

Dermatitis exfoliative NOS

Nausea

Hyperglycemia NOS

Depression NEC

Lymphopenia

Myalgia

Peripheral sensory neuropathy

Stomatitis

Platelet count decreased

Blood albumin decreased

Weight decreased

Anorexia

Hypocalcemia

Hyponatremia

Hematologic-Other

Neutropenia

Alopecia

100%

80%

60%

40%

20%

Study treatment Arm

Hormones and RT

Hormones and RT Plus Chemotherapy

NOM-ERA Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiation + FOLFOXExperimental Treatment5 Interventions

Pelvic radiotherapy 5GY x 5 fractions once daily Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). Oxaliplatin day 1 every 14 days Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. 5-FU bolus day 1 every 14 days 5-FU infusion day 1 every 14 days over 46 hours Alternatively CAPOX (capecitabine and oxaliplatin) may be given for 5 cycles over 15 weeks. An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation therapy

2013

Completed Phase 3

~2850

FOLFOX regimen

2009

Completed Phase 3

~2440

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,930 Previous Clinical Trials

2,298,922 Total Patients Enrolled

Hyun Kim, M.D.Principal InvestigatorWashington University School of Medicine

7 Previous Clinical Trials

178 Total Patients Enrolled

Media Library

Colorectal Cancer Research Study Groups: Radiation + FOLFOX

Frequently Asked Questions

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

In what quantity of medical facilities is this clinical experiment being conducted?

"Currently, there are 4 trial sites actively recruiting patients for this study: University of Vermont Medical Center in Burlington, Mayo Clinic in Rochester, University of Colorado in Aurora and other locations."

Answered by AI

What is the enrollment size of this research endeavor?

"In order to complete the trial, 68 participants who meet the pre-established criteria must enroll. Patients have the option of participating at either University of Vermont Medical Center in Burlington or Mayo Clinic in Rochester."

Answered by AI

Is this research program currently enrolling participants?

"Affirmative. According to clinicaltrials.gov, this medical trial is presently searching for 68 participants at 4 distinct sites and has been on the website since July 1st 2020 with its most recent update occurring September 8th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Non-Operative Management and Early Response Assessment in Rectal Cancer

2020. "Non-Operative Management and Early Response Assessment in Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03904043.

All > Vermont