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

ConditionRectal Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorBassett Healthcare

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or greater

ECOG PS 0-2

Stage II or III, newly diagnosed, biopsy proven, rectal cancer

No prior treatment for rectal cancer

Disqualifiers

Patients with metastatic disease

Patients that are not candidates for surgery

Patients that refuse neoadjuvant treatment

Trial population

Adult patients with biopsy proven , resectable rectal cancer

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Operative Group1 intervention

Group B: Non-operative Group1 intervention

Trial outcomes

Primary outcomes

patient preferences for operative vs. non-operative management of rectal cancer

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

Time frame

8 months

Secondary outcomes

Patient adherence to surveillance protocols

Percentage of patients who choose non-operative management who successfully comply with the post-neoadjuvant treatment surveillance protocol

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bassett Healthcare

Lead sponsor

Source ClinicalTrials.gov

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