What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as short-course radiation therapy (SCRT) followed by chemotherapy, have several known side effects. Radiation therapy can cause acute issues like proctitis, enteritis, and diarrhea, which typically resolve within weeks, and long-term effects like chronic radiation enteritis, leading to frequent loose stools, rectal bleeding, and urgency. Chemotherapy can result in hand-foot syndrome, diarrhea, nausea, vomiting, stomatitis, fatigue, and neuropathy. These side effects can vary in severity and duration, affecting the patient's quality of life.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer that involve a combination of radiation therapy and chemotherapy. One such regimen includes the use of fluoropyrimidines like 5-fluorouracil (5-FU) or capecitabine, often in combination with radiation therapy to shrink the tumor before surgery. Oxaliplatin is another chemotherapy agent that has been approved for use in combination with 5-FU and leucovorin, known as the FOLFOX regimen, which can be used postoperatively to eliminate remaining cancer cells. These treatments aim to improve local control of the disease and reduce the risk of recurrence.

What other types of research exist?

Promising novel alternatives to SCRT followed by chemotherapy for colorectal cancer patients include: 1) Neoadjuvant chemoradiotherapy with immune checkpoint inhibitors, which are being investigated for their potential to enhance the immune response against cancer cells. 2) Targeted therapies such as anti-EGFR or anti-VEGF agents combined with chemoradiotherapy, which aim to improve treatment outcomes by targeting specific molecular pathways involved in tumor growth. 3) Personalized treatment approaches based on genomic profiling to tailor therapy according to the genetic makeup of the tumor, potentially improving efficacy and reducing toxicity.

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Chemotherapy

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

N/A

Waitlist Available

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

Must not have

No prior radiation therapy to the pelvis.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of radiation therapy and chemotherapy for patients with rectal cancer that hasn't spread. The goal is to see if this treatment can effectively shrink and eliminate the cancer without surgery. This approach has shown potential benefits in treatment compliance and outcomes.

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.

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.

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.

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.

Exclusion Criteria

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

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I have not had radiation therapy to my pelvic area.

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I do not have any serious illnesses like heart failure or uncontrolled infections.

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I have been treated with oxaliplatin or capecitabine for cancer.

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I am allergic to capecitabine, 5FU, oxaliplatin, or leucovorin.

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I have had surgery or treatment for rectal cancer before.

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

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

Primary study objectives

Clinical complete response rate

Secondary study objectives

Incidence of grade 3 or higher toxicity during treatment

Incidence of post chemoradiotherapy grade 3 or higher toxicity

Progression-free survival (PFS)

+1 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: NOS

12%

Late RT Toxicity: Other GI: 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

Depression NEC

Nausea

Hyperglycemia NOS

Lymphopenia

Myalgia

Peripheral sensory neuropathy

Platelet count decreased

Hypocalcemia

Hyponatremia

Blood albumin decreased

Stomatitis

Weight decreased

Anorexia

Hematologic-Other

Neutropenia

Alopecia

100%

80%

60%

40%

20%

Study treatment Arm

Hormones and RT

Hormones and RT Plus Chemotherapy

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: 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 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for colorectal cancer include radiation therapy and chemotherapy. Radiation therapy, such as Short Course Radiation Therapy (SCRT), uses high-energy radiation to shrink tumors by damaging the DNA of cancer cells, preventing them from growing and dividing. Chemotherapy involves drugs that target and kill rapidly dividing cells, including cancer cells, to eliminate any remaining cancer cells after surgery or radiation. This combination is crucial for colorectal cancer patients as it helps to reduce tumor size before surgery, making it easier to remove, and to destroy any residual cancer cells afterward, thereby lowering the risk of cancer recurrence.

Neoadjuvant Pelvic Radiotherapy in the Management of Rectal Cancer with Synchronous Liver Metastases: Is It Worth It?The role of chemotherapy in localized and locally advanced rectal cancer: A systematic revision.Multidisciplinary treatment of patients with rectal cancer: Development during the past decades and plans for the future.