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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks, 12 weeks, 5 years, 1 year, 2 years
  • Procedures mentioned: Questionnaires, MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Treatment choices are: 1. 5-Fluorouracil or Capecitabine with radiotherapy for 6 weeks, followed by a break of 8-12 weeks."
  • "Total Neoadjuvant Therapy (TNT) option 1: 6 cycles of Leucovorin Calcium, Fluorouracil, and Oxaliplatin (FOLFOX) over 12 weeks, followed by 6 weeks 5-Fluorouracil or Capecitabine with radiation, then a break of 10-12 weeks 3."
  • "TNT option 2: 6 weeks 5-Fluorouracil or Capecitabine with radiation, followed by 6 cycles of FOLFOX over 12 weeks, then a break of 10-12 weeks."
  • "Patients will have CT imaging of the chest/abdomen/pelvis every 6-12 months for 5 years following resection, per NCCN guidelines for patients with stage II or stage III rectal cancer."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows adults in rural areas with newly diagnosed stage II or III rectal cancer. It looks at how patients do with their chosen treatment, including care without surgery, and how they feel about their choices. Clinic visits and surveys will track results and whether patients follow their care plans for about six years, depending on treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Able to care for yourself and be out of bed or a chair for more than half the day (ECOG activity score 0–2).
  • Newly diagnosed stage II or III rectal cancer, confirmed by testing a tissue sample.
  • No past treatment for rectal cancer or radiation to the pelvis (lower belly area).
  • Willing to have study tests and checkups after treatment.
  • If you could become pregnant, have a blood or urine test showing no pregnancy within 2 weeks before joining.
  • Not pregnant or breastfeeding.
  • Able to understand the study and agree to join.

Who can't join

  • Cancer has spread to distant parts of the body.
  • Cannot have surgery.
  • Not willing to have treatment given before surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NY