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

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 chemotherapy and local excision for colorectal cancer safe for humans?

Chemotherapy for colorectal cancer has been studied for safety, with attention to managing side effects like nausea and fatigue. Safety measures include monitoring kidney and liver function, and adjusting treatment for elderly patients or those with other health issues. ^{1 2 3 4 5}

How does the chemotherapy and local excision treatment for colorectal cancer differ from other treatments?

This treatment combines standard chemotherapy with local excision, which is a surgical removal of the tumor, offering a more targeted approach compared to systemic chemotherapy alone. It may provide an option for patients who have not responded to other standard treatments, potentially improving outcomes by directly addressing the tumor site. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment for colorectal cancer?

Research shows that chemotherapy, especially when combined with surgery, can improve survival rates for colorectal cancer patients. Chemotherapy regimens that include drugs like fluorouracil and oxaliplatin have been effective in increasing survival and reducing recurrence in colorectal cancer. ^{7 11 12 13 14}

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]

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]

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]

Citations

1. Japan pubmed.ncbi.nlm.nih.gov

Recent advances in multidisciplinary approach for rectal cancer. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Adjuvant treatment of colorectal cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Evolution of nonsurgical therapy for colorectal cancer. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Epidemiology, treatment and chemoprevention in colorectal cancer. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Update on chemotherapy for advanced colorectal cancer. [2005]

6. England 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. [2020]

7. France pubmed.ncbi.nlm.nih.gov

[Prerequisites to the administration and prevention of adverse effects of chemotherapy in colorectal cancer]. [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Management pattern and medication-related harms and its predictors in colorectal cancer patients: an institutional-based retrospective study. [2023]

9. Greece pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Adjuvant Chemotherapy for Resected Colorectal Cancer in Patients With Renal Insufficiency: A Pooled Analysis of Individual Patient Data from Five Japanese Large-scale Clinical Trials. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Managing the side effects of chemotherapy for colorectal cancer. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Mitomycin C and high-dose 5-fluorouracil with folinic acid as a therapeutic option for heavily pretreated patients with metastatic colorectal cancer: prospective phase II trial. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Chemotherapy for colorectal cancer in the metastatic and adjuvant setting: past, present and future. [2007]

14. England pubmed.ncbi.nlm.nih.gov

Current chemotherapeutic possibilities in the treatment of colorectal cancer. [2019]