NCT02942901

Brief Summary

Surgery has been available for the treatment of pulmonary metastases in metastatic colorectal cancer and promising overall survival was observed in retrospective studies with selected patients. This study investigated whether the preoperative FDG- PET/CT scan influences survival in this patient group. Furthermore, we tried to identify other prognostic factors associated with overall survival and progression-free survival.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

4.7 years

First QC Date

October 21, 2016

Last Update Submit

September 3, 2020

Conditions

Metastatic Colorectal Cancer

Keywords

PET-CTpulmonary metstasectomy

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    5 years

Secondary Outcomes (1)

  • Number and sites of metastases detected by PET-CT

    3 years

Interventions

PET-CTPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with pulmonary metastases eligible for pulmonary metastasectomy

You may qualify if:

  • Patients over 18 years with pulmonary metastases eligible for pulmonary metastasectomy

You may not qualify if:

  • Second primary cancer within the last 2 years (exception basal cell carcinoma of the skin)
  • Pregnancy,
  • Drug addiction,
  • Renal dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lung Clinic Heckeshorn at HELIOS Hospital Emil von Behring

Berlin, 14165, Germany

Location

Related Publications (1)

  • Pastorino U, Veronesi G, Landoni C, Leon M, Picchio M, Solli PG, Leo F, Spaggiari L, Pelosi G, Bellomi M, Fazio F. Fluorodeoxyglucose positron emission tomography improves preoperative staging of resectable lung metastasis. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1906-10. doi: 10.1016/s0022-5223(03)00211-3.

    PMID: 14688704BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 24, 2016

Study Start

January 1, 2015

Primary Completion

September 1, 2019

Study Completion

January 1, 2020

Last Updated

September 4, 2020

Record last verified: 2020-09

Locations

DE(1)