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

29 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well liver surgery and chemotherapy compared to chemotherapy alone work in treating patients with colorectal cancer that has spread to the liver (liver metastases) that can be removed by surgery and that has spread to the lungs (lung metastases) that cannot be removed by surgery. Liver surgery removes a portion of the liver affected by the tumor. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Liver surgery and chemotherapy may work better than chemotherapy alone in treating patients with colorectal cancer which has spread to the liver and lungs.

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.

What data supports the effectiveness of the treatment combining surgery and chemotherapy for colorectal cancer with liver metastases?

Research shows that combining surgery with chemotherapy can improve survival rates for patients with colorectal cancer that has spread to the liver. Studies indicate that patients who receive both treatments tend to live longer compared to those who only undergo surgery or chemotherapy alone. ^{1 2 3 4 5}

Is the combination of surgery and chemotherapy for colorectal cancer safe?

The combination of surgery and chemotherapy for colorectal cancer is generally considered safe, but it can cause liver-related side effects. Some chemotherapy drugs may lead to liver damage, which can affect liver function and recovery after surgery. It's important for a team of healthcare professionals to carefully plan and manage treatment to minimize these risks. ^{6 7 8 9 10}

How is the treatment of surgery combined with chemotherapy unique for colorectal cancer with liver metastases?

This treatment is unique because it combines surgery with chemotherapy to increase the chances of survival for patients with colorectal cancer that has spread to the liver. The chemotherapy can shrink tumors to make them operable, and new surgical techniques and targeted drugs improve the effectiveness of this approach. ^{4 11 12 13 14}

Research Team

Yun S Chun

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

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

Platelet count < 50,000/uL

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Is there a survival benefit to neoadjuvant versus adjuvant chemotherapy, combined with surgery for resectable colorectal liver metastases? [2021]

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

Managing colorectal cancer liver metastases. [2016]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[HEMIHEPATECTOMY FOR RESECTABLE HEPATIC METASTASIS FROM COLORECTAL CANCER WITH POOR PROGNOSIS]. [2018]

4. Romania pubmed.ncbi.nlm.nih.gov

Colorectal cancer with liver metastases -- is there a chance for cure? [2014]

5. Japan pubmed.ncbi.nlm.nih.gov

[Chemotherapy and hepatectomy for liver metastasis from colorectal cancer]. [2009]

6. England pubmed.ncbi.nlm.nih.gov

Chemotherapy-associated liver injury in colorectal cancer. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Hepatic toxicities associated with the use of preoperative systemic therapy in patients with metastatic colorectal adenocarcinoma to the liver. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Selective resection of colorectal liver metastases. [2022]

9. Japan pubmed.ncbi.nlm.nih.gov

[Idiopathic thrombocytopenic purpura during chemotherapy for liver metastasis of rectal cancer]. [2015]

10. Germany pubmed.ncbi.nlm.nih.gov

Impact of preoperative targeted therapy on postoperative complications after resection of colorectal liver metastases. [2021]

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

The role of chemotherapy in managing patients with resectable liver metastases. [2010]

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

Activation of the mTOR Pathway by Oxaliplatin in the Treatment of Colorectal Cancer Liver Metastasis. [2021]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Integration of neoadjuvant and adjuvant chemotherapy in patients with resectable liver metastases from colorectal cancer. [2018]

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

Management of liver metastases from colorectal cancer. [2022]