Surgery + Chemotherapy for Colorectal Cancer

Overseen By Yun Shin Chun, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, High bilirubin, Low platelets, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Variable, based on treatment response

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining liver surgery and chemotherapy is more effective than chemotherapy alone for treating colorectal cancer that has spread to the liver and lungs. Researchers aim to determine if removing liver metastases and using chemotherapy (cytotoxic therapy) offers more benefits than chemotherapy alone for cancer that has also spread to the lungs (lung metastases). Suitable candidates for this trial have colorectal cancer with liver tumors that can be surgically removed, while lung tumors cannot be operated on due to their location or other health reasons. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since patients previously treated with chemotherapy and biologic agents are eligible, it seems you may not need to stop those treatments.

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

Research has shown that liver surgery for colorectal cancer is generally safe. Studies indicate that removing part of the liver, known as liver resection, can be effective and has a well-documented safety record. Specifically, laparoscopic liver surgery, which involves smaller incisions, carries a lower risk of major complications and results in shorter surgery times.

Chemotherapy is a common treatment for colorectal cancer and is usually well-tolerated. Different drugs can cause different side effects, but doctors select treatments based on what is best for each patient. While side effects like nausea or fatigue can occur, doctors have methods to help manage them.

Overall, both liver surgery and chemotherapy are established treatments. They are generally safe, but like any medical procedure, there can be risks. Discussing potential side effects and benefits with a healthcare provider is always important when considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for colorectal cancer because they combine surgery and chemotherapy in a potentially more effective way. Unlike standard treatments that often rely on just chemotherapy or separate surgeries, this approach integrates liver surgery directly with chemotherapy. This could make it possible to remove tumors more effectively, especially if they spread to the lungs. Additionally, this method allows doctors to tailor chemotherapy schedules based on individual patient needs, potentially increasing the chances of successful treatment outcomes.

What evidence suggests that this trial's treatments could be effective for colorectal cancer with liver and lung metastases?

Research has shown that liver surgery can be highly effective for patients with colorectal cancer that has spread to the liver. Studies indicate that 5-year survival rates for these patients range from 47% to 60%, meaning nearly half of the patients are still alive five years after surgery. In this trial, some participants will undergo both liver surgery and chemotherapy, which might yield better results than chemotherapy alone. Chemotherapy, a common treatment, helps stop cancer cells from growing and spreading. Participants in the chemotherapy-only group will receive treatment at the discretion of the treating oncologist. ^{6 7 8 9 10}

Who Is on the Research Team?

Yun S Chun

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for colorectal cancer patients with liver metastases that can be surgically removed and lung metastases that cannot. Eligible participants may have had previous chemotherapy, have a limited number of small lung nodules, and must be able to undergo imaging tests. Those with additional disease sites, high bilirubin levels, low platelets, poor performance status or who are pregnant cannot join.

Inclusion Criteria

I have liver metastases that can be surgically removed, confirmed by CT or MRI.

My lung scans show 14 or fewer small, smooth nodules under 2 cm without benign features.

My lung cancer cannot be removed surgically due to its location, spread, or my other health issues.

Exclusion Criteria

I am mostly bedridden due to my health condition.

Platelet count < 50,000/uL

My scans show cancer outside the liver and lungs, except for small mediastinal lymph nodes and specific lymph node swelling.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo hepatectomy and receive chemotherapy, or receive chemotherapy alone. Lung metastasectomy may be performed if lung tumors become resectable.

Variable, based on treatment response

Follow-up

Participants are monitored for survival, adverse events, and metastases development every 3-6 months

Up to 3 years

Follow-up visits every 3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Chemotherapy
• Liver Surgery
• Metastasectomy

Trial Overview The study compares the effectiveness of liver surgery combined with chemotherapy versus chemotherapy alone in treating colorectal cancer that has spread to the liver and lungs. It aims to determine if adding surgery improves outcomes for these patients.

How Is the Trial Designed?

Group I: Group I (surgery, chemotherapy) Experimental Treatment 5 Interventions

Patients undergo hepatectomy and receive chemotherapy at the discretion of treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.

Group II: Group II (chemotherapy) Active Control 4 Interventions

Patients receive chemotherapy at the discretion of the treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in United States as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Canada as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Japan as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in China as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Switzerland as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Hepatic resection is currently the only treatment with curative potential for colorectal liver metastasis, but many patients experience recurrences, often in the remnant liver.

Combining surgery with adjuvant chemotherapy may improve survival rates, but further clinical trials are needed to determine the optimal treatment protocols and drug combinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chemotherapy and hepatectomy for liver metastasis from colorectal cancer]. Ohkubo, T., Takayama, T.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3496330/

Survival after liver resection in metastatic colorectal cancer Of the 93 studies we identified that reported survival, only 20 (22%) reported 10-year survival rates, whereas the majority reported 3- or 5-year survival.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2049080120300108

Oncological outcomes of repeat metastasectomy for ... Liver resection is the standard and only curative treatment for colorectal liver metastases, and the 5-year survival rate after complete resection for patients ...

3. jgo.amegroups.org jgo.amegroups.org/article/view/32297/html

Hepatic metastasis from colorectal cancer - Kow Several studies have shown 5-year OS rates of 47–60% after hepatectomy for colorectal metastases (10-12). However, recurrence occurs in 40–75% of patients after ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1421269/

Hepatic Resection for Colorectal Liver Metastases: A Cost ... The efficacy of hepatic resection for metastases from colorectal cancer has been debated, despite reported 5-year survival rates of 20% to 40%. Resection is ...

5. ar.iiarjournals.org ar.iiarjournals.org/content/42/11/5497

Efficacy of Adjuvant Chemotherapy Following Curative ... Conclusion: Adjuvant chemotherapy after curative CRLM resection may improve the prognosis of patients with three or more risk factors including preoperative CEA ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4911703/

Long-term Oncological Outcomes for Simultaneous Resection ... Twenty-five percent of patients with colorectal cancer present with simultaneous liver metastasis. Complete resection is the only potential curative treatment.

7. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-022-00937-z

Safety and long-term prognosis of simultaneous versus staged ... Simultaneous resection is safe and effective for SCLM patients. The long-term prognosis is equivalent to that of the traditional staged resection.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11120322/

Surgical Resection in Colorectal Liver Metastasis The effectiveness of surgical treatment of liver metastases from colorectal cancer is well-supported by evidence in the literature, with liver ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1091255X24000209

The oncologic outcome and prognostic factors for solitary ... This study aimed to analyze significant prognostic factors associated with tumor recurrence and long-term survival after liver resection for solitary ...

10. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)00414-3/fulltext

P-216 Surgical safety and oncological outcomes of ... Laparoscopic liver surgery is a safe and effective method of CRLM treatment. LLR was associated with decrease in major morbidity, shorted surgery duration, and ...