Chemotherapy and/or Metastasectomy in Treating Patients With Metastatic Colorectal Adenocarcinoma With Lung Metastases
The Role of Multimodality Management in Risk-Stratified Patients With Lung-Limited Metastatic Colorectal Cancer
2 other identifiers
interventional
40
2 countries
6
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2018
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 2, 2018
CompletedFirst Submitted
Initial submission to the registry
July 17, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2030
January 9, 2026
January 1, 2026
11.6 years
July 17, 2018
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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).
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.
Up to 2 years
Study Arms (4)
Group 1A (chemotherapy, metastasectomy)
EXPERIMENTALLow 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)
EXPERIMENTALLow risk patients undergo metastasectomy.
Group 2A (metastasectomy)
EXPERIMENTALHigh risk patients undergo metastasectomy.
Group 2B (chemotherapy)
EXPERIMENTALHigh 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.
Interventions
Undergo pulmonary metastasectomy
Receive chemotherapy
Eligibility Criteria
You may qualify if:
- 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
- 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
- +11 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (6)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Baylor Colllege of Medicine
Houston, Texas, 77030, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
University Health Network Princess Margaret Cancer Center P2C
Toronto, Ontario, M5G 2M9, Canada
University of Montreal
Montreal, Quebec, H3T 1J7, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mara B. Antonoff, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2018
First Posted
July 26, 2018
Study Start
July 2, 2018
Primary Completion (Estimated)
January 31, 2030
Study Completion (Estimated)
January 31, 2030
Last Updated
January 9, 2026
Record last verified: 2026-01