NCT04245683 · Bassett Healthcare
Feasibility of Non-Operative Management of Rectal Cancer in a Rural Population
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Bowel/rectal resection
surgical removal of the portion of the rectum where the tumor was originally identified
OTHER
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 measures
patient preferences for operative vs. non-operative management of rectal cancer
Time frame: 8 months
Number of eligible patients who select operative versus non-operative management after successfully completing approximately 20 weeks of neoadjuvant treatment and the 10-12 week post treatment observation period
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- For a patient to be considered eligible for this study, ALL of the following conditions must be met:
- Age 18 or greater
- ECOG PS 0-2
- Stage II or III, newly diagnosed, biopsy proven, rectal cancer
- No prior treatment for rectal cancer
- No prior pelvic radiotherapy
- Willing to undergo study related testing and monitoring after treatment
- Women of childbearing potential must rule out pregnancy within 2 weeks prior to registration with a blood test or urine study
- Women must not be pregnant or breastfeeding
- Able to provide informed consent
Exclusion criteria
- Patients are NOT considered eligible for this study if any of the following conditions apply:
- Patients with metastatic disease
- Patients that are not candidates for surgery
- Patients that refuse neoadjuvant treatment
Where
- Cooperstown, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 7, 2023 · Source of record for eligibility and locations