Recruiting

Observational Study

Sponsor:

Bassett Healthcare

Code:

NCT04245683

Conditions

Rectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bowel/rectal resection

non-operative follow up

Study Details

Brief summary:

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.

Conditions

Rectal Cancer

Study ID

NCT04245683

Start date

Feb 1, 2020

Status verified date

Mar, 2023

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

For a patient to be considered eligible for this study, ALL of the following conditions must be met:

1. Age 18 or greater
2. ECOG PS 0-2
3. Stage II or III, newly diagnosed, biopsy proven, rectal cancer
4. No prior treatment for rectal cancer
5. No prior pelvic radiotherapy
6. Willing to undergo study related testing and monitoring after treatment
7. Women of childbearing potential must rule out pregnancy within 2 weeks prior to registration with a blood test or urine study
8. Women must not be pregnant or breastfeeding
9. Able to provide informed consent

Exclusion Criteria:

Patients are NOT considered eligible for this study if any of the following conditions apply:

1. Patients with metastatic disease
2. Patients that are not candidates for surgery
3. Patients that refuse neoadjuvant treatment

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Operative Group

Patients who select operative treatment and follow up after successful neoadjuvant treatment.

Non-operative Group

Patients who select non-operative follow up after successful neoadjuvant treatment

Interventions

Bowel/rectal resection

surgical removal of the portion of the rectum where the tumor was originally identified

non-operative follow up

patients who choose the non-operative option will be required to adhere to a very intensive follow up protocol, including endoscopy and CT imaging

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jennifer Victory, RN

6075476965jennifer.victory@bassett.org

Katelyn Tessier

607-547-3073kately.tessier@bassett.org

Locations

Bassett Healthcare Network

Recruiting

Cooperstown, New York, United States, 13326

Contacts

Jennifer Victory, RN

607-547-6965jennifer.victory@bassett.org

Katelyn Tessier

607-547-3073katelyn.tessier@bassett.org

Principal Investigator:

Eric Bravin, MD

More Information

Sponsor

Bassett Healthcare

Last update posted

Mar 7, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bassett Healthcare on 2023-03-07.