Colorectal AdenocarcinomaPhase 2NCT03599752
Chemotherapy and/or Metastasectomy in Treating Patients With Metastatic Colorectal Adenocarcinoma With Lung Metastases
A Phase 2 study testing Chemotherapy and Metastasectomy in people with Colorectal Adenocarcinoma and Colorectal Carcinoma Metastatic in the Lung, run by M.D. Anderson Cancer Center at 6 sites in 2 countries.
Trial summary
This phase II trial studies how well chemotherapy and/or metastasectomy work in treating patients with colorectal adenocarcinoma that has spread to the lungs (metastases). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma, Colorectal Carcinoma Metastatic in the Lung, Stage IV Colorectal Cancer AJCC v8
- What is being tested?
- Chemotherapy and Metastasectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 2 Jul 2018to 31 Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of colorectal adenocarcinoma
- Metastatic colorectal cancer involving the lung classified as determined by the treating clinical team
- Diagnosis of colorectal metastasis to lung made either histologically with trans-thoracic needle biopsy or clinically based on radiographic imaging
- Identification as a medically appropriate candidate for surgical resection of the lung metastasis (metastases) according to the evaluating cardiothoracic surgeon. Standard justification for deeming a patient medically operable based on:
- Pulmonary reserve adequate to tolerate complete resection of all intrathoracic disease, as deemed by thoracic surgeon, which may be determined by:
- Baseline forced expiratory volume in one second (FEV1) > 40% predicted
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- Post-operative predicted FEV1 > 30% predicted
- Diffusion capacity of the lung for carbon monoxide (DLCO) > 40% predicted
- Absent baseline hypoxemia and/or hypercapnia
- Exercise oxygen consumption > 50% predicted
- Absent severe pulmonary hypertension
- Absent severe cerebral, cardiac, or peripheral vascular disease
- Absent severe chronic heart disease
- Ability to tolerate surgical resection and acceptable operative risk as deemed by thoracic surgeon based on performance status and medical comorbidities
- Identification as a medically appropriate candidate for systemic chemotherapy at the discretion of the evaluating medical oncologist
- Resection/definitive therapy of primary colorectal tumor with no suspicion of recurrence. Prior radiation to a rectal adenocarcinoma is permitted
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability to provide informed consent for participation
- Leukocytes >= 2,000/mcL
- Absolute neutrophil count >= 1,000/mcL
- Hemoglobin >= 9.0 gm/dL
- Platelet count >= 100,000/mcL
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN
- Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl >= 50 mL/min (if using the Cockcroft-Gault formula)
- Patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study
Who cannot join
- Tumor involvement at other metastatic sites (e.g., liver, distant lymph nodes) that has not been definitively treated. Prior surgical resection for metastatic disease at other (non-pulmonary) sites is permitted
- Presence of intact primary colorectal adenocarcinoma (or of an anastomotic recurrence)
- Previous radiotherapy to a lung metastasis that is still detectable radiographically
- Known dihydropyrimidine dehydrogenase (DPD) deficiency that would preclude the patient from tolerating 5- fluorouracil chemotherapy
- Prior intolerance of systemic therapies used as standard regimens in the treatment of metastatic CRC that would prohibit further receipt of systemic chemotherapy and/or biologic agents -e.g.,5-fluorouracil, oxaliplatin, irinotecan, anti-VEGF therapies (e.g., bevacizumab, ramucirumab), or anti-EGFR therapies (e.g., cetuximab, panitumumab, for patients with RAS wild-type colorectal tumors)
- Prior therapy with regorafenib or trifluridine/tipiracil (TAS-102) for metastatic/unresectable colorectal cancer
- Synchronous primary or prior malignancy in the past 5 years other than non-melanomatous skin cancer or in situ cancer
- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Baylor Colllege of Medicine
Houston, Texas, 77030
M D Anderson Cancer Center
Houston, Texas, 77030
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Washington University School of Medicine
St Louis, Missouri, 63110
Canada2 sites
University of Montreal
Montreal, Quebec, H3T 1J7
University Health Network Princess Margaret Cancer Center P2C
Toronto, Ontario, M5G 2M9
About this study
Official title: The Role of Multimodality Management in Risk-Stratified Patients With Lung-Limited Metastatic Colorectal Cancer
This phase II trial studies how well chemotherapy and/or metastasectomy work in treating patients with colorectal adenocarcinoma that has spread to the lungs (metastases). Drugs used in chemotherapy 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. Metastasectomy is a surgical procedure that removes tumors formed from cells that have spread from other places in the body. It is not yet known if chemotherapy and metastasectomy together works better in treating patients with metastatic colorectal adenocarcinoma with lung metastases.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare recurrence-free survival in patients with "low risk" lung-limited metastatic colorectal cancer (mCRC) undergoing pulmonary metastasectomy with or without perioperative chemotherapy.
II. To compare overall survival in patients with "high risk" lung-limited mCRC receiving systemic chemotherapy with or without surgical resection.
SECONDARY OBJECTIVES:
- To compare grade 3 and 4 adverse events in patients receiving surgical resection and/or chemotherapy in the management of lung-limited mCRC.
EXPLORATORY OBJECTIVES:
- To evaluate for changes in circulating tumor deoxyribonucleic acid (DNA) following surgical resection and/or systemic chemotherapy in patients with lung-limited mCRC.
OUTLINE: Patients are assigned to 1 of 2 risk groups (low or high).
GROUP 1 (LOW RISK): Patients are randomized to 1 of 2 groups.
GROUP 1A: 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.
GROUP 1B: Patients undergo metastasectomy.
GROUP 2 (HIGH RISK): All high risk patients receive standard of care chemotherapy for 3 months in the absence of disease progression or unacceptable toxicity. Patients without progressive disease after 3 months are then randomized to 1 of 2 groups.
GROUP 2A: Patients undergo metastasectomy.
GROUP 2B: 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.
After completion of study treatment, patients are followed up periodically for up to 5 years.
- Conditions
- Colorectal Adenocarcinoma, Colorectal Carcinoma Metastatic in the Lung, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8
- Being tested
- Chemotherapy, Metastasectomy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Receive chemotherapy
MetastasectomyProcedure or surgery
Undergo pulmonary metastasectomy
| Study group | Role | What they receive |
|---|---|---|
| Group 1A (chemotherapy, metastasectomy) | Experimental | 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. Receives: Drug: Chemotherapy; Procedure: Metastasectomy |
| Group 1B (metastasectomy) | Experimental | Low risk patients undergo metastasectomy. Receives: Procedure: Metastasectomy |
| Group 2A (metastasectomy) | Experimental | High risk patients undergo metastasectomy. Receives: Procedure: Metastasectomy |
| Group 2B (chemotherapy) | Experimental | 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. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (Low risk)
The primary objective for the low risk group is to evaluate the efficacy of chemotherapy plus surgical resection versus surgical resection alone measured by recurrence-free survival (RFS). The event includes recurrence and death due to any cause. Patients will be stratified at randomization according to three variables: age (age >= 60 years vs age < 60 years), RAS mutation status (mutant vs wild type), and location of primary tumor within colon/rectum (right/cecum/ascending colon/hepatic flexure/transverse colon vs left/distal to transverse colon).
Measured: Up to 2 years
Overall survival (High risk)
The primary objective for the high-risk group is to evaluate the efficacy of chemotherapy plus surgical resection versus chemotherapy alone measured by overall survival (OS). The event includes death due to any cause. Patients will be stratified at randomization according to 4 variables: response to chemotherapy in the preceding three months of treatment (complete or partial response vs stable disease by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria), RAS mutated vs RAS wild type tumors, right versus left-sided primary tumors, and oxaliplatin-based vs irinotecan-based chemotherapy in the initial treatment period on study.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start2 Jul 2018
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mara B. Antonoff, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599752
- Sponsor's protocol ID
- 2017-0905
- Other IDs
- NCI-2018-01456, 2017-0905
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2018
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Multimodality Management in Risk-Stratified Patients With Lung-Limited Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03599752
- Acronym / sponsor ID
- 2017-0905
- Conditions
- Colorectal Adenocarcinoma, Colorectal Carcinoma Metastatic in the Lung, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well chemotherapy and/or metastasectomy work in treating patients with colorectal adenocarcinoma that has spread to the lungs (metastases). Drugs used in chemotherapy 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. Metastasectomy is a surgical procedure that removes tumors formed from cells that have spread from other places in the body. It is not yet known if chemotherapy and metastasectomy together works better in treating patients with metastatic colorectal adenocarcinoma with lung metastases.
Detailed description
PRIMARY OBJECTIVES:
- To compare recurrence-free survival in patients with "low risk" lung-limited metastatic colorectal cancer (mCRC) undergoing pulmonary metastasectomy with or without perioperative chemotherapy.
II. To compare overall survival in patients with "high risk" lung-limited mCRC receiving systemic chemotherapy with or without surgical resection.
SECONDARY OBJECTIVES:
- To compare grade 3 and 4 adverse events in patients receiving surgical resection and/or chemotherapy in the management of lung-limited mCRC.
EXPLORATORY OBJECTIVES:
- To evaluate for changes in circulating tumor deoxyribonucleic acid (DNA) following surgical resection and/or systemic chemotherapy in patients with lung-limited mCRC.
OUTLINE: Patients are assigned to 1 of 2 risk groups (low or high).
GROUP 1 (LOW RISK): Patients are randomized to 1 of 2 groups.
GROUP 1A: 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.
GROUP 1B: Patients undergo metastasectomy.
GROUP 2 (HIGH RISK): All high risk patients receive standard of care chemotherapy for 3 months in the absence of disease progression or unacceptable toxicity. Patients without progressive disease after 3 months are then randomized to 1 of 2 groups.
GROUP 2A: Patients undergo metastasectomy.
GROUP 2B: 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.
After completion of study treatment, patients are followed up periodically for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1A (chemotherapy, metastasectomy) | Experimental | Drug: Chemotherapy, Procedure: MetastasectomyLow 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. |
| Group 1B (metastasectomy) | Experimental | Procedure: MetastasectomyLow risk patients undergo metastasectomy. |
| Group 2A (metastasectomy) | Experimental | Procedure: MetastasectomyHigh risk patients undergo metastasectomy. |
| Group 2B (chemotherapy) | Experimental | Drug: ChemotherapyHigh 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Histological confirmation of colorectal adenocarcinoma
- Metastatic colorectal cancer involving the lung classified as determined by the treating clinical team
- Diagnosis of colorectal metastasis to lung made either histologically with trans-thoracic needle biopsy or clinically based on radiographic imaging
- Identification as a medically appropriate candidate for surgical resection of the lung metastasis (metastases) according to the evaluating cardiothoracic surgeon. Standard justification for deeming a patient medically operable based on:
- Identification as a medically appropriate candidate for systemic chemotherapy at the discretion of the evaluating medical oncologist
Key exclusion criteria (8 listed)
- Tumor involvement at other metastatic sites (e.g., liver, distant lymph nodes) that has not been definitively treated. Prior surgical resection for metastatic disease at other (non-pulmonary) sites is permitted
- Presence of intact primary colorectal adenocarcinoma (or of an anastomotic recurrence)
- Previous radiotherapy to a lung metastasis that is still detectable radiographically
- Known dihydropyrimidine dehydrogenase (DPD) deficiency that would preclude the patient from tolerating 5- fluorouracil chemotherapy
- Prior intolerance of systemic therapies used as standard regimens in the treatment of metastatic CRC that would prohibit further receipt of systemic chemotherapy and/or biologic agents -e.g.,5-fluorouracil, oxaliplatin, irinotecan, anti-VEGF therapies (e.g., bevacizumab, ramucirumab), or anti-EGFR therapies (e.g., cetuximab, panitumumab, for patients with RAS wild-type colorectal tumors)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyAlso: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, GeneralReceive chemotherapy | Drug | Group 1A (chemotherapy, metastasectomy), Group 2B (chemotherapy) |
| MetastasectomyUndergo pulmonary metastasectomy | Procedure or surgery | Group 1A (chemotherapy, metastasectomy), Group 1B (metastasectomy), Group 2A (metastasectomy) |
Primary outcome
Recurrence-free survival (Low risk)
Time frame: Up to 2 years
The primary objective for the low risk group is to evaluate the efficacy of chemotherapy plus surgical resection versus surgical resection alone measured by recurrence-free survival (RFS). The event includes recurrence and death due to any cause. Patients will be stratified at randomization according to three variables: age (age >= 60 years vs age < 60 years), RAS mutation status (mutant vs wild type), and location of primary tumor within colon/rectum (right/cecum/ascending colon/hepatic flexure/transverse colon vs left/distal to transverse colon).
Overall survival (High risk)
Time frame: Up to 2 years
The primary objective for the high-risk group is to evaluate the efficacy of chemotherapy plus surgical resection versus chemotherapy alone measured by overall survival (OS). The event includes death due to any cause. Patients will be stratified at randomization according to 4 variables: response to chemotherapy in the preceding three months of treatment (complete or partial response vs stable disease by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria), RAS mutated vs RAS wild type tumors, right versus left-sided primary tumors, and oxaliplatin-based vs irinotecan-based chemotherapy in the initial treatment period on study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mara B. Antonoff, MD principal investigator
M.D. Anderson Cancer Center
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy and Metastasectomy in people with Colorectal Adenocarcinoma and Colorectal Carcinoma Metastatic in the Lung, run by M.D. Anderson Cancer Center at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (Low risk) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.