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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT04808323
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Rectal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    825 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 — DEVICE
    50 Gy over 25 frac.
  • Cohort A: Dose Escalation Radiation — DEVICE
    Cohort A will receive 14 Gy boost for a total of 64 Gy over 32 total fractions.
  • Cohort B: Dose Escalation Radiation — DEVICE
    Cohort B will receive 18 Gy boost for a total of 68 Gy over 34 total fractions.
  • Cohort C: Dose Escalation Radiation — DEVICE
    Cohort C will receive 22 Gy boost for a total of 72 Gy over 36 total fractions.
  • FOLFOX — DRUG
    After 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.)

Study Details

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

Key Dates

Start date
Jun 17, 2021
Status verified
Mar 2026
Primary completion
Apr 14, 2027
Completion
Jan 20, 2029

Study Design

Enrollment
22 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Radiation dose: 64 Gy over 32 fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to total dose of 64 Gy over 32 total fractions.
  • Experimental: Cohort B
    Radiation dose: 68 Gy over approximately 34 fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to 68 Gy over 34 total fractions.
  • Experimental: Cohort C
    Radiation dose: 72 Gy over 36 total fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to 72 Gy over 36 total fractions

Primary Outcome Measure

The number of subjects in Cohort A with serious adverse events during radiation. [ Time Frame: Up to 11.5-week period ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    414-805-8900
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226
William Hall, MD
[email protected]
414-805-4400
Carrie Peterson, MD
[email protected]
414-955-5783
Carrie Peterson, MD (PRINCIPAL_INVESTIGATOR)
William Hall, MD (PRINCIPAL_INVESTIGATOR)

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Froedtert & the Medical College of Wisconsin· Milwaukee, WI

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