MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer
ConditionRectal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin
About this trial
This study is a prospective, open-label, phase I design.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Capecitabine
Drug825 mg/m\^2 twice daily during radiation therapy. (Fluorouracil (5-FU) may be used at the discretion of the treating medical oncologists.) This chemotherapy will be given during the initial radiation dose (50 Gy over 25 frac) and continue for Cohorts A, B, and C.
Initial Dose of Radiation before Dose Escalation
Device50 Gy over 25 frac.
Cohort A: Dose Escalation Radiation
DeviceCohort A will receive 14 Gy boost for a total of 64 Gy over 32 total fractions.
Cohort B: Dose Escalation Radiation
DeviceCohort B will receive 18 Gy boost for a total of 68 Gy over 34 total fractions.
Cohort C: Dose Escalation Radiation
DeviceCohort C will receive 22 Gy boost for a total of 72 Gy over 36 total fractions.
FOLFOX
DrugAfter the completion of radiation, subjects will receive up to eight cycles of systemic chemotherapy. (FOLFIRINOX may be used at the discretion of the treating medical oncologists.)
Treatment groups
22 Participants
are divided into 3 treatment groupsGroup A: Cohort AExperimental treatment 4 interventions
Group B: Cohort BExperimental treatment 4 interventions
Group C: Cohort CExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
The number of subjects in Cohort A with serious adverse events during radiation.
This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.
Time frame
Up to 11.5-week period2
The number of subjects in Cohort B with serious adverse events during radiation.
This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.
Time frame
Up to 11.5-week period3
The number of subjects in Cohort C with serious adverse events during radiation.
This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.
Time frame
Up to a 12.1-week period.Secondary outcomes
1
The number of subjects in Cohort A with a complete clinical response (CCR) to treatment.
Four weeks following completion of chemotherapy, radiation therapy (RT), and neoadjuvant systemic chemotherapy, the patient will be evaluated by the study surgeon to assess local response. CCR is defined as meeting the following criteria: 1. No palpable tumor on digital exam. 2. Endoscopic evaluation consistent with the following. 1. Flat scar with no ulceration and intact mucosa. 2. Disappearance of neoplastic pit pattern without use of magnification. 3. Disappearance of neoplastic nodule or stenosis.
Time frame
31.5 weeks2
The number of subjects in Cohort B with a complete clinical response (CCR) to treatment.
Four weeks following completion of chemotherapy, RT, and neoadjuvant systemic chemotherapy, the patient will be evaluated by the study surgeon to assess local response. CCR is defined as meeting the following criteria: 1. No palpable tumor on digital exam. 2. Endoscopic evaluation consistent with the following. 1. Flat scar with no ulceration and intact mucosa. 2. Disappearance of neoplastic pit pattern without use of magnification. 3. Disappearance of neoplastic nodule or stenosis.
Time frame
31.5 weeks3
The number of subjects in Cohort C with a complete clinical response (CCR) to treatment.
Four weeks following completion of chemotherapy, RT, and neoadjuvant systemic chemotherapy, the patient will be evaluated by the study surgeon to assess local response. CCR is defined as meeting the following criteria: 1. No palpable tumor on digital exam. 2. Endoscopic evaluation consistent with the following. 1. Flat scar with no ulceration and intact mucosa. 2. Disappearance of neoplastic pit pattern without use of magnification. 3. Disappearance of neoplastic nodule or stenosis.
Time frame
32.1 weeks4
The number of subjects in Cohort A with a noncomplete response (NCR) to treatment.
Four weeks following completion of chemotherapy, RT, and neoadjuvant systemic chemotherapy, the patient will be evaluated by the study surgeon to assess local response. A noncomplete clinical response is defined as any state not meeting the following criteria: 1. No palpable tumor on digital exam. 2. Endoscopic evaluation consistent with the following. 1. Flat scar with no ulceration and intact mucosa. 2. Disappearance of neoplastic pit pattern without use of magnification. 3. Disappearance of neoplastic nodule or stenosis. If the tumor site does not meet the above criteria, the patient will be classified as noncomplete response (NCR).
Time frame
31.5 weeksSponsors and contacts
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Source ClinicalTrials.gov