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Anti-tumor antibiotic, Anti-metabolites
Chemotherapy + Surgery for Colorectal Cancer
Phase 2
Waitlist Available
Led By Mara B. Antonoff, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of colorectal metastasis to lung made either histologically with trans-thoracic needle biopsy or clinically based on radiographic imaging
Histological confirmation of colorectal adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying if chemotherapy and/or removing tumors from the lungs works well to treat patients with colorectal adenocarcinoma that has spread there.
Who is the study for?
This trial is for patients with colorectal adenocarcinoma that has spread to the lungs. Candidates must have good lung function, no severe heart disease, and be able to undergo surgery and chemotherapy. They should not have other untreated cancer sites or a history of certain cancers within 5 years, except some skin or in situ cancers.Check my eligibility
What is being tested?
The study is examining the effectiveness of combining chemotherapy with a surgical procedure called metastasectomy to remove lung tumors in patients whose colorectal cancer has spread there. It's unclear if using both treatments offers better outcomes than one alone.See study design
What are the potential side effects?
Chemotherapy can cause side effects like nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, and potential damage to organs such as the liver or kidneys. Surgical risks include complications from anesthesia, bleeding, infection at the surgery site, and prolonged recovery time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer diagnosis was confirmed through a biopsy or imaging.
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My diagnosis is colorectal adenocarcinoma.
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My colorectal cancer has spread to my lungs.
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My primary colorectal tumor was surgically removed and there's no sign it has come back.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (High risk)
Recurrence-free survival (Low risk)
Trial Design
4Treatment groups
Experimental Treatment
Group I: Group 2B (chemotherapy)Experimental Treatment1 Intervention
High risk patients continue standard of care chemotherapy for 6 months in the absence of disease progression or unacceptable toxicity. Patients with stable disease or radiographic response after 6 months may then cross over to Group 2A.
Group II: Group 2A (metastasectomy)Experimental Treatment1 Intervention
High risk patients undergo metastasectomy.
Group III: Group 1B (metastasectomy)Experimental Treatment1 Intervention
Low risk patients undergo metastasectomy.
Group IV: Group 1A (chemotherapy, metastasectomy)Experimental Treatment2 Interventions
Low risk patients receive standard of care chemotherapy for 3 months prior to and 3 months after undergoing metastasectomy in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Metastasectomy
2010
N/A
~100
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,741 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,113 Total Patients Enrolled
Mara B. Antonoff, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgeon agrees I can have surgery to remove lung metastases.I am using effective birth control during this study.I cannot tolerate standard treatments for metastatic colorectal cancer.My lung cancer diagnosis was confirmed through a biopsy or imaging.I have taken regorafenib or TAS-102 for advanced colorectal cancer.I have not had cancer other than non-dangerous skin cancer or very early stage cancer in the last 5 years.My diagnosis is colorectal adenocarcinoma.My colorectal cancer has spread to my lungs.I am considered fit for surgery based on my lung function, heart health, and overall fitness.My oncologist approves me for chemotherapy.My primary colorectal tumor was surgically removed and there's no sign it has come back.My kidney function, measured by creatinine levels or clearance, is within the required range.I cannot tolerate 5-fluorouracil chemotherapy due to a DPD deficiency.I have a type of colon cancer that has not been surgically removed.I've had radiotherapy for lung cancer that can still be seen on scans.I am fully active or restricted in physically strenuous activity but can do light work.My cancer has spread to other parts of my body and has not been treated yet.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2A (metastasectomy)
- Group 2: Group 1A (chemotherapy, metastasectomy)
- Group 3: Group 1B (metastasectomy)
- Group 4: Group 2B (chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many study participants are there in total?
"That is correct. The clinicaltrials.gov website provides information showing that this trial is currently recruiting patients. This study was originally posted on July 2nd, 2018 and has been seeking 365 participants from 9 different locations since then."
Answered by AI
In how many different places can patients participate in this trial?
"9 hospitals are participating in this study, such as Duke University Medical Center in Durham, M D Anderson Cancer Center in Houston, and Thomas Jefferson University in Philadelphia."
Answered by AI
Has the FDA released a statement in regards to Chemotherapy?
"While chemotherapy has shown some promise in prior trials, there is currently no data supporting its efficacy. However, it received a score of 2 due to the fact that there is evidence indicating that it is safe."
Answered by AI
Are there any participants needed for this research project?
"Yes, the website provides updated information that this trial is looking for patients. The posting dates back to July 2nd, 2018 with recent updates in September of 2021. There are 9 different locations enrolling a total of 365 patients."
Answered by AI
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