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Trial record 54 of 478 for:    colon cancer | ( Map: Texas, United States )

Liver Surgery and Chemotherapy in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery and Lung Metastases That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT02738606
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 that can be removed by surgery and that has spread to the lungs that cannot be removed by surgery. Liver surgery removes a portion of the liver affected by the tumor. 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. Liver surgery and chemotherapy may work better than chemotherapy alone in treating patients with colorectal cancer which has spread to the liver and lungs.

Condition or disease Intervention/treatment Phase
Metastatic Malignant Neoplasm in the Liver Metastatic Malignant Neoplasm in the Lung Recurrent Colorectal Carcinoma Stage IV Colorectal Cancer AJCC v7 Stage IVA Colorectal Cancer AJCC v7 Stage IVB Colorectal Cancer AJCC v7 Drug: Chemotherapy Other: Laboratory Biomarker Analysis Procedure: Metastasectomy Other: Quality-of-Life Assessment Procedure: Therapeutic Conventional Surgery Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine a survival benefit of liver resection in patients with resectable liver and unresectable low-volume pulmonary metastases from colorectal cancer.

SECONDARY OBJECTIVES:

I. To identify biomarkers in blood and resected liver specimens that correlate with survival, and development of extrahepatic and extrapulmonary metastases.

II. To assess patients' quality-of-life in each treatment arm with serial questionnaires.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: 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: 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.

After completion of study treatment, patients are followed up every 3-6 months up to 3 years.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Phase II Trial of Liver Resection Versus No Surgery in Patients With Liver and Unresectable Pulmonary Metastases From Colorectal Cancer
Actual Study Start Date : May 25, 2016
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (surgery, chemotherapy)
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.
Drug: Chemotherapy
Other Names:
  • Chemo
  • Chemotherapy (NOS)
  • Chemotherapy, Cancer, General

Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Metastasectomy
Undergo lung metastasectomy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Procedure: Therapeutic Conventional Surgery
Undergo hepatectomy

Active Comparator: Group II (chemotherapy)
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.
Drug: Chemotherapy
Other Names:
  • Chemo
  • Chemotherapy (NOS)
  • Chemotherapy, Cancer, General

Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Metastasectomy
Undergo lung metastasectomy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. Overall survival [ Time Frame: From the date of randomization to the date of death or the date of last follow-up, assessed up to 3 years ]
    The primary analysis will be performed in an intention-to-treat data set. Stratified log-rank test adjusting for the study stratification factors will be used to compare overall survival between the two treatment arms. The hazards ratio of overall survival for the surgery arm compared to the non-surgery arm will be estimated by fitting Cox proportional hazards regression models, adjusting for the effects of covariates including stratification factors.


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 3 years ]
    Tabulated by frequency and percentages, by grade, and by their relations to surgical treatment.

  2. Extrahepatic and extrapulmonary metastases [ Time Frame: Up to 3 years ]
    The Kaplan-Meier method will be used to estimate time to extrahepatic and extrapulmonary metastases.

  3. Intrahepatic recurrence [ Time Frame: Up to 3 years ]
    The Kaplan-Meier method will be used to estimate time to intrahepatic recurrence among patients randomized to surgery.

  4. Biomarker levels in blood and resected liver specimens [ Time Frame: Up to 3 years ]
    Univariate and multivariate Cox proportional hazards models will be fitted to evaluate the association between biomarkers in blood and resected liver specimens and time to event outcomes, including overall survival development of extrahepatic and extrapulmonary metastases, and time to intrahepatic recurrence among patients randomized to surgery. Univariate and multivariate logistic regression will be used to assess the association between biomarkers and response to chemotherapy

  5. Scores of the Functional Assessment of Cancer Therapy - General 7 questionnaire [ Time Frame: Up to 3 years ]
    Summarized using descriptive statistics including mean, standard deviation, median, and range. Summation of item GP1, GP4, GP2, and GE6 (higher score indicates worse condition) and summation of GF5, GF3 and GF7 (higher score indicates better condition) will be calculated for each patient. Two sample t-tests will be used to compare scores of each item or summations between the two treatment arms.

  6. Patients who abandon treatment [ Time Frame: Up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with synchronous or metachronous diagnosis of resectable liver metastases by computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen: a) patients requiring percutaneous or intraoperative ablation of liver metastases < 2 cm in size are eligible; b) patients who underwent prior liver resection or ablation for colorectal liver metastases are eligible
  • Patients previously treated with systemic chemotherapy and/or biologic agents for colorectal cancer are eligible
  • The primary tumor in the colon or rectum may be intact or resected
  • Low-volume lung metastases are defined as solid pulmonary nodules < 2 cm with non-spiculated contours, no benign-appearing calcifications, and =< 14 in number, diagnosed by computed tomography of the chest or positron emission tomography (PET)
  • Lung metastases will be unresectable due to anatomic location, distribution, or patients' comorbidities, as determined by review of imaging by a faculty member in the Department of Thoracic & Cardiovascular Surgery
  • Patients must sign a study-specific consent form
  • Patients will undergo CT imaging of the chest, abdomen, and pelvis to evaluate lung and liver metastases within 30 days of registration; for patients who cannot tolerate CT contrast or have hepatic steatosis that reduces the sensitivity of CT, MRI of the liver will be performed

Exclusion Criteria:

  • Radiographic evidence of disease other than liver and lungs, with the exception of mediastinal lymph nodes < 2 cm and hepatoduodenal ligament lymphadenopathy, diagnosed by computed tomography, magnetic resonance imaging, or positron emission tomography
  • Serum bilirubin >= 2 mg/dL
  • Platelet count < 50,000/microL
  • Eastern Cooperative Oncology Group (ECOG) performance status of 3-4
  • Patient refusal to participate in randomization
  • Pregnant women are excluded from this study
  • Planned stereotactic body radiation therapy (SBRT) for the pulmonary metastases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738606


Contacts
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Contact: Yun Shin Chun, MD 713-563-9682 yschun@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Yun S. Chun    713-563-9682      
Principal Investigator: Yun S. Chun         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Yun S Chun M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02738606     History of Changes
Other Study ID Numbers: 2015-1133
NCI-2016-00740 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2015-1133 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms, Second Primary
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases