NCT04245683

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
15mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Feb 2020Aug 2027

First Submitted

Initial submission to the registry

January 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

7 years

First QC Date

January 27, 2020

Last Update Submit

March 3, 2023

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    8 months

Secondary Outcomes (1)

  • Patient adherence to surveillance protocols

    5 years

Study Arms (2)

Operative Group

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

Procedure: Bowel/rectal resection

Non-operative Group

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

Other: non-operative follow up

Interventions

Bowel/rectal resectionPROCEDURE

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

Operative Group
non-operative follow upOTHER

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

Non-operative Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with biopsy proven , resectable rectal cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Proctectomy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, ColorectalDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Eric Bravin, MD

    Bassett Healthcare

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Victory, RN

CONTACT

6075476965jennifer.victory@bassett.org

Katelyn Tessier

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending physician - medical oncology

Study Record Dates

First Submitted

January 27, 2020

First Posted

January 29, 2020

Study Start

February 1, 2020

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)