Chemotherapy and Local Excision for Colorectal Cancer

Overseen By Susan M Szpunar, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: Under 18, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to treat rectal cancer to improve quality of life and reduce the risk of recurrence. Researchers are testing different timings and methods for administering standard chemotherapy and possibly using less invasive surgery, such as transanal local excision. Patients with specific types of rectal cancer, such as tumors in the lower or middle rectum, might be suitable candidates. The trial aims to determine if these changes can help patients live better and longer. As an unphased trial, this study offers patients the opportunity to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that transanal local excision, a component of the treatment in this study, is generally safe and well-tolerated. For patients with early-stage rectal cancer, this surgery yields good results. One study reported a 100% survival rate for patients with very early-stage cancer and 80.2% for those with early-stage cancer, suggesting the procedure's effectiveness and safety. Another review confirmed its safety and effectiveness for certain early cancer stages.

The chemotherapy component of the treatment uses standard drugs already approved for rectal cancer. These drugs have been widely used, and doctors are familiar with their safety and side effects. While side effects can occur, they are usually known and manageable. Overall, both the surgical and chemotherapy treatments have demonstrated safety with proper medical supervision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment approach for colorectal cancer because it combines chemotherapy with a tailored surgical procedure based on the tumor's response. Unlike the standard approach, which often involves a full surgical resection regardless of the tumor's characteristics, this method allows for a less invasive transanal local resection if the tumor responds well to chemotherapy. This personalized strategy means patients could potentially experience fewer complications and a quicker recovery while still effectively managing their cancer.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research has shown that transanal local excision, a less invasive surgery, can be effective for rectal cancer patients. In this trial, all participants will receive standard-of-care chemotherapy, and based on their response, they may undergo transanal local excision. For example, one study found that 92% of patients retained organ integrity after this treatment following chemotherapy and radiation. Another study reported that 82.1% of patients remained disease-free three years after the procedure, with results comparable to more invasive surgeries. Additionally, patients with early-stage cancer treated with this method had high survival rates, with some stages reaching up to 100%. These findings suggest that transanal local excision can be a promising option for treating rectal cancer while maintaining quality of life. ^{2 3 5 6 7}

Who Is on the Research Team?

Amr Aref, MD

Principal Investigator

Ascension SME

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have been diagnosed with rectal cancer.

My cancer stage was determined using a physical exam and various scans.

Exclusion Criteria

Do not complete informed consent

You are pregnant.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive neo-adjuvant FOLFOX chemotherapy to increase the percentage of patients with pathologic complete remission

8-12 weeks

Chemo-Radiotherapy

Participants undergo preoperative chemo-radiotherapy with 5FU/Capecitabine

5-6 weeks

Surgery

Based on pathologic response, participants receive either transanal local resection or full resection

1 week

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Standard of care chemotherapy
• Transanal Local Excision

Trial Overview 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.

How Is the Trial Designed?

Group I: Neoadjuvant Chemotherapy and Follow-up Surgery Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Ascension South East Michigan

Lead Sponsor

Trials

19

Recruited

32,400+

Published Research Related to This Trial

Chemotherapy combinations, such as fluoropyrimidine with oxaliplatin or irinotecan, are standard treatments for advanced colorectal cancer, achieving about a 50% tumor response rate and a median overall survival of 20 months.

While adding agents like bevacizumab and cetuximab can improve response rates and progression-free survival, the overall survival benefits are marginal, highlighting the need for biomarkers to better target therapies and manage costs and toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of nonsurgical therapy for colorectal cancer. Midgley, RS., Yanagisawa, Y., Kerr, DJ.[2021]

Colorectal cancer (CRC) is a major cause of cancer-related deaths, with only about 60% of patients surviving five years post-diagnosis, highlighting the need for effective treatments.

Adjuvant chemotherapy significantly benefits stage III CRC patients, and new agents like irinotecan improve survival rates in metastatic cases, suggesting advancements in treatment options and the potential for targeted screening based on familial risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology, treatment and chemoprevention in colorectal cancer. Rougier, P., Mitry, E.[2020]

In a study of 46,692 elderly colorectal cancer patients, those receiving intravenous chemotherapy experienced significantly higher rates of adverse events, particularly with oxaliplatin-based regimens, which caused more nausea, neutropenia, and neuropathy compared to fluorouracil alone.

Patients aged 70 and older were more likely to suffer from adverse effects such as infection, anemia, delirium, and heart disease, highlighting the need for careful patient selection and support when administering chemotherapy to older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of toxicity profiles of fluorouracil versus oxaliplatin regimens in a large population-based cohort of elderly patients with colorectal cancer. Cen, P., Liu, C., Du, XL.[2020]

Recent advancements in treatment for metastatic colorectal cancer, including the use of irinotecan and oxaliplatin alongside fluoropyrimidine therapy, have led to improved response rates and progression-free survival compared to older treatments.

The identification of biological markers for prognosis and treatment response is crucial for personalizing chemotherapy regimens, which could enhance outcomes for patients both with metastatic disease and in adjuvant settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on chemotherapy for advanced colorectal cancer. Haller, DG.[2005]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12444340/

Local excision in rectal cancer: When and for whom? - PMC A retrospective study by Chen et al[11] demonstrated a 92% organ preservation rate in patients who underwent LE after nCRT. However, critical ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2829541

Transanal vs Laparoscopic Total Mesorectal Excision and ... The transanal TME group exhibited 3-year disease-free survival of 82.1%, compared with 79.4% in the laparoscopic TME group.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0305737224000811

Oncological outcomes of local excision versus radical ... Total mesorectal excision (TME) remains the surgical gold standard for the treatment of rectal cancer, reducing local recurrence to less than 10 % and ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0294510

Long-term efficacy of transanal local excision versus total ... The purpose of this meta-analysis is to compare the long-term efficacy of transanal local excision (TLE) versus total mesorectal excision ...

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1545547/full

Efficacy and safety of transanal endoscopic microsurgery ... The results showed that the overall survival rate was 100% for T0 stage, 98.1% for Tis (carcinoma in situ) stage, and 80.2% for early stage ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39145821/

Transanal total mesorectal excision: short- and long-term ... Conclusion: TaTME proves effective in addressing the anatomical and technical challenges of low rectal surgery and is associated with pleasing ...

7. sages.org sages.org/publications/guidelines/clinical-spotlight-review-transanal-minimally-invasive-surgery-tamis/

Clinical Spotlight Review: TransAnal Minimally Invasive ... TAMIS is a safe and effective means of local resection for benign and favorable early stage (T1) cancers following adequate workup for rectal lesions.