RecruitingPhase 1

MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer

United States22 participantsStarted 2021-06-17

Plain-language summary

This study is a prospective, open-label, phase I design.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18.
✓. Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum.
✓. Determined on staging evaluation to be clinical stage I, II or III.
✓. No concerning unequivocal or biopsy-proven metastatic disease. Patients are eligible with either no evidence of distant metastatic disease, or "equivocal" evidence of distant metastatic disease, as judged by the multidisciplinary tumor board. This "equivocal" definition can include small lung or liver lesions that are not able to be radiographically characterized otherwise.
✓. Eastern Cooperative Oncology Group (ECOG) status 0-2 within 45 days of study entry.
✓. History/physical examination, including collection of weight and vital signs within 45 days prior to start of treatment.
✓. MR of the rectum is mandatory for staging and follow-up.
✓. Chest CT scan within 45 days prior to study entry.

✕. Biopsy-proven distant metastatic disease or high clinical concern for metastatic disease and tumor conference consensus of stage IV disease.
✕. Prior invasive malignancy (except nonmelanomatous skin cancer, noninvasive breast cancer (DCIS), or prostate cancer under active surveillance). Other malignancies are allowed if patient has been disease free for a minimum of three years
✕. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
✕. Any major surgery within 28 days prior to study entry, except colonic stent placement, intestinal diversion without resection or vascular access insertion.
✕. Severe, active comorbidity, defined as follows:
✕. Unstable angina and/or congestive heart failure requiring hospitalization within the last six months.
✕. Transmural myocardial infarction within three months prior to study entry.
✕. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.

The number of subjects in Cohort A with serious adverse events during radiation.

Timeframe: Up to 11.5-week period

The number of subjects in Cohort B with serious adverse events during radiation.

Timeframe: Up to 11.5-week period

The number of subjects in Cohort C with serious adverse events during radiation.

Timeframe: Up to a 12.1-week period.

NCT IDNCT04808323

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-14

Medical College of Wisconsin Cancer Center Clinical Trials Office

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18.
✓. Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum.
✓. Determined on staging evaluation to be clinical stage I, II or III.
✓. No concerning unequivocal or biopsy-proven metastatic disease. Patients are eligible with either no evidence of distant metastatic disease, or "equivocal" evidence of distant metastatic disease, as judged by the multidisciplinary tumor board. This "equivocal" definition can include small lung or liver lesions that are not able to be radiographically characterized otherwise.
✓. Eastern Cooperative Oncology Group (ECOG) status 0-2 within 45 days of study entry.
✓. History/physical examination, including collection of weight and vital signs within 45 days prior to start of treatment.
✓. MR of the rectum is mandatory for staging and follow-up.
✓. Chest CT scan within 45 days prior to study entry.

✕. Biopsy-proven distant metastatic disease or high clinical concern for metastatic disease and tumor conference consensus of stage IV disease.
✕. Prior invasive malignancy (except nonmelanomatous skin cancer, noninvasive breast cancer (DCIS), or prostate cancer under active surveillance). Other malignancies are allowed if patient has been disease free for a minimum of three years
✕. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
✕. Any major surgery within 28 days prior to study entry, except colonic stent placement, intestinal diversion without resection or vascular access insertion.
✕. Severe, active comorbidity, defined as follows:
✕. Unstable angina and/or congestive heart failure requiring hospitalization within the last six months.
✕. Transmural myocardial infarction within three months prior to study entry.
✕. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.

What they're measuring

The number of subjects in Cohort A with serious adverse events during radiation.

Timeframe: Up to 11.5-week period

The number of subjects in Cohort B with serious adverse events during radiation.

Timeframe: Up to 11.5-week period

The number of subjects in Cohort C with serious adverse events during radiation.

Timeframe: Up to a 12.1-week period.