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WithdrawnNCT03096899Updated Aug 31, 2018

A Study to Estimate Overall Survival in Patients Receiving Best Supportive Care for Treatment-Resistant, Metastatic Colorectal Carcinoma

An observational study in Metastatic Colorectal Carcinoma, sponsored by The Rogosin Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-31.

Sponsored by The Rogosin Institute · Observational

Why this study was withdrawn
The investigator conducting the study determined that the entry criteria for the proposed subjects was too difficult to determine in a retrospective review.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study summary

The primary objective of this study is to estimate overall survival in patients only receiving best supportive care (BSC) for treatment-resistant, metastatic colorectal carcinoma. The primary efficacy outcome is overall survival, defined as the time from the date of the radiographic scan demonstrating disease progression post available treatments (time of origin, T0) to death from any cause.

Read the detailed description

This is a retrospective chart review and prospective observational study. Patients will be considered for enrollment if they are receiving BSC and have already decided independently of this study not to pursue further therapeutic treatment of their cancer. Patients must have received at least two prior treatments for their disease, such as chemotherapy, targeted therapy or other regimens.

The study will consist of administration of informed consent, which will include permission to review medical records and record relevant medical information, agreement to be followed for survival, and evaluation of the appropriate inclusion/exclusion entry criteria.

Patients will not have any study-specific assessments performed as part of this study, and will be followed only for survival.

Approximately 80 patients with treatment-resistant, metastatic colorectal cancer who are only receiving BSC, will be entered in the study at no more than five sites in the United States

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Conditions studied

  • Metastatic Colorectal Carcinoma
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

Browse Carcinoma studies →

Lead sponsor

The Rogosin Institute is the lead sponsor of 24 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study patient population is composed of patients with treatment-resistant, metastatic colorectal cancer who are only receiving BSC.

Inclusion criteria

Patients must meet all of the following criteria to be considered eligible to participate in the study:

  1. Adult men or women, aged 18 years or older, with histologically-confirmed, metastatic adenocarcinoma of the colon or rectum that is resistant to available treatment options, including at least two such options from available chemotherapy, targeted and other regimens.
  2. Radiographically documented evidence of disease progression from the most recent therapy administered prior to the initiation of BSC.
  3. Life expectancy of at least six weeks, in the Investigator's opinion, at the time of disease progression from the most recent therapy administered prior to the initiation of BSC.
  4. In the Investigator's opinion, a surgical candidate at the time of disease progression. Initiation of treatment with BSC only within two months.
  5. Able to provide written informed consent (by patient or family member or health proxy).

Exclusion criteria

Exclusion Criteria:

Patients who, at the time of disease progression from the most recent therapy administered prior to the initiation of BSC, meet any of the following criteria will be excluded from participating in the study:

  1. Documentation of hepatic blood flow abnormalities, i.e., portal vein hypertension and thrombosis, and/or a large volume of ascites.
  2. Documentation of concurrent cancer of any other type (Note: patients with non-melanoma skin cancers are still considered eligible).
  3. Documentation of positive test result for human immunodeficiency virus (HIV) or any hepatitis (other than Hepatitis A).
  4. Considered by the Investigator to be unsuitable for participation in the study upon review of medical history, physical examination or clinical laboratory test results.-
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • OtherObservational

    Best Supportive Care

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What researchers measure

Primary outcomes

  1. Overall Survival

    Death from any cause.

    Time frame: From the date of prior radiographically documented disease progression associated with the most recent therapy administered prior to the initiation of BSC to the date of death, assessed up to 10 years

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Study locations

1 site
  • Calvary Hospital
    Bronx, New York 10461, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03096899
Lead sponsor
The Rogosin Institute
Responsible party
Sponsor
First posted
Mar 30, 2017
Start date
Jan 2016
Primary completion
Aug 22, 2018
Completion
Aug 22, 2018
Last update
Aug 31, 2018

Study contacts

Barry Smith, M.D., Ph.D.
study director · The Rogosin Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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