What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as oxaliplatin-based chemotherapy regimens (FOLFOX and CAPOX) and radiation therapy, are associated with several side effects. Chemotherapy can cause neurotoxicity, leading to peripheral neuropathy, as well as gastrointestinal issues like nausea, vomiting, diarrhea, and mucositis. Radiation therapy often results in bowel toxicity, including diarrhea, proctitis, and enteritis, and can also cause fatigue and skin reactions. These side effects can significantly impact the patient's quality of life, necessitating careful management and supportive care.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer that align with the approach of modified chemotherapy and radiation timing and administration. Key approvals include fluoropyrimidine-based therapies such as 5-fluorouracil (5-FU) and capecitabine, often used in combination with oxaliplatin (as in the FOLFOX regimen). Additionally, irinotecan is approved for use in combination with fluoropyrimidines. Radiation therapy is also a standard component of treatment, particularly in rectal cancer, where it is used preoperatively or postoperatively to reduce local recurrence. These treatments aim to enhance survival rates and improve quality of life by optimizing the timing and administration of chemotherapy and radiation.

What other types of research exist?

Promising novel alternatives for colorectal cancer treatment in 2024 include: 1) Total neoadjuvant therapy (TNT) combining induction chemotherapy with chemoradiotherapy to improve tumor downsizing and increase the likelihood of complete resection. 2) Immunotherapy combinations, particularly for patients with microsatellite instability-high (MSI-H) tumors. 3) Targeted therapies such as anti-EGFR agents (e.g., cetuximab) and anti-VEGF agents (e.g., bevacizumab) in combination with chemotherapy. 4) Personalized treatment plans based on genetic profiling to tailor therapy to individual tumor characteristics. 5) Less invasive surgical techniques, such as transanal local excision, for patients with a complete clinical response to neoadjuvant therapy.

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Chemotherapy and Local Excision for Colorectal Cancer

N/A

Recruiting

Led By Amr Aref, MD

Research Sponsored by Ascension South East Michigan

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Tumor in the low or mid rectum (up to 11 cm from the anal verge)

Must not have

Less than 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Summary

This trial is testing if giving rectal cancer patients a specific chemotherapy before surgery can improve their quality of life and reduce cancer recurrence. The goal is to see if this approach can help patients avoid more invasive surgeries and achieve better overall results.

Who is the study for?

This trial is for adults over 18 with a specific type of rectal cancer (adenocarcinoma) located in the low or mid rectum. Candidates must not be pregnant, should have completed informed consent, and have a clinical stage T3/N0-N1M0 or some T2 cases requiring surgery.

What is being tested?

The study tests if changing the timing and method of chemotherapy and radiation can reduce distant recurrence rates in rectal cancer patients while also using less invasive surgery when needed to improve quality of life.

What are the potential side effects?

Potential side effects may include those commonly associated with chemotherapy such as nausea, fatigue, hair loss, increased risk of infection; radiation-related skin changes; and complications from less invasive surgical procedures.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My tumor is located in the lower or middle part of my rectum.

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I have been diagnosed with rectal cancer.

Exclusion Criteria

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

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Complete remission

Disease progression

Local resection

+1 more

Secondary study objectives

Patient health status

Patient quality of life

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant Chemotherapy and Follow-up SurgeryExperimental Treatment1 Intervention

All patients will receive standard of care therapy and based upon their response will either receive transanal local resection or full resection, based on pathologic response.

0 / 4Eligibility 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

Common treatments for colorectal cancer include chemotherapy and radiation therapy. Chemotherapy agents like fluoropyrimidines (e.g., 5-FU) and oxaliplatin disrupt DNA synthesis and function, leading to cancer cell death. Radiation therapy damages the DNA of cancer cells, preventing their growth and division. Combining these treatments can enhance their effectiveness, reduce tumor size, and improve surgical outcomes. Optimizing the timing and administration of these therapies can reduce distant recurrence rates and improve quality of life by minimizing side effects and enhancing overall treatment efficacy.