Feasibility of Non-Operative Management of Rectal Cancer in a Rural Population

Part of paid clinical trials in Cooperstown, New York.

Sponsor
Bassett Healthcare
Study ID
NCT04245683
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bowel/rectal resection — PROCEDURE
    surgical removal of the portion of the rectum where the tumor was originally identified
  • non-operative follow up — OTHER
    patients who choose the non-operative option will be required to adhere to a very intensive follow up protocol, including endoscopy and CT imaging

Study Details

This is an observational research study. Patients with rectal cancer can choose different courses of treatment. This study will follow these patients over the course of approximately six years, depending on their treatment. Patients will be monitored through clinic visits and survey assessments to see how they do, how they feel regarding their treatment choices, and their outcomes. The surveys will analyze the impact of the patients' treatment choices, as well as patient adherence, in a rural setting.

Key Dates

Start date
Feb 1, 2020
Status verified
Mar 2023
Primary completion
Feb 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Operative Group
    Patients who select operative treatment and follow up after successful neoadjuvant treatment.
  • Arm: Non-operative Group
    Patients who select non-operative follow up after successful neoadjuvant treatment

Primary Outcome Measure

patient preferences for operative vs. non-operative management of rectal cancer [ Time Frame: 8 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Bassett Healthcare NetworkCooperstownNew York13326
Jennifer Victory, RN
[email protected]
607-547-6965
Katelyn Tessier
[email protected]
607-547-3073
Eric Bravin, MD (PRINCIPAL_INVESTIGATOR)
Raul Monzon, MD (SUB_INVESTIGATOR)
Luis Oceguera, MD (SUB_INVESTIGATOR)
Marcy Canary, MD (SUB_INVESTIGATOR)
Bharatsinh Gharia, MD (SUB_INVESTIGATOR)
Bryan Lee, DO (SUB_INVESTIGATOR)
James Leonardo, MD (SUB_INVESTIGATOR)
Anush Patel, MD (SUB_INVESTIGATOR)
Timothy Korytko, MD (SUB_INVESTIGATOR)
Julia Manzerova, MD (SUB_INVESTIGATOR)
Alfred Tinger, MD (SUB_INVESTIGATOR)

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Bassett Healthcare Network· Cooperstown, NY

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