Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing whether MRI-guided adaptive radiation therapy—radiation adjusted using repeated MRI scans to target the tumour—can safely deliver higher doses to locally advanced rectal cancer while limiting exposure to nearby organs. The phase I trial will increase the dose in cohorts to find the highest dose that does not cause unacceptable toxicity, alongside capecitabine and then FOLFOX chemotherapy.
The idea is that stronger, more precisely targeted radiation might control the tumour well enough to preserve the rectum and avoid surgery, but this trial is measuring safety and the maximum tolerated dose, not whether patients live longer or preserve the organ. Any improvement would first be a dose that can be given without serious treatment-related complications.
Worth knowing: This is a small, non-randomised phase I trial with no comparison group, so it cannot establish that the treatment preserves organs or controls cancer better than standard treatment.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT04808323 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 22 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Medical College of Wisconsin |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Capecitabine
- Device Initial Dose of Radiation before Dose Escalation
- Device Cohort A: Dose Escalation Radiation
- Device Cohort B: Dose Escalation Radiation
- Device Cohort C: Dose Escalation Radiation
- Drug FOLFOX
What it is measuring
The number of subjects in Cohort A with serious adverse events during radiation.
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
Study Rationale: There are limited studies evaluating real-time adaptive radiation therapy for locally advanced (Stage I-III) rectal adenocarcinoma with the goal of accomplishing organ preservation. We are testing higher doses of radiation therapy, using a novel method of real-time adaptive MRI-based radiation therapy treatment.
Hypothesis: We hypothesize that adaptive magnetic resonance (MR) -guided radiation therapy will result in acceptable toxicity and that a maximum-tolerated dose can be determined in a phase I setting.
Intervention Description: The intervention in this circumstance is higher doses of radiation therapy focused within the tumor given using adaptive MR guidance. Radiation Doses being applied in this study:
Cohort A- 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.
Cohort B- 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.
Cohort C- 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.
Dose-Limiting Toxicity from Radiation Therapy: A dose-limiting toxicity (DLT) as per NCI CTCAE version 5.…
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Rectal
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Age ≥ 18.
2. Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum.
3. Determined on staging evaluation to be clinical stage I, II or III.
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) status 0-2 within 45 days of study entry.
6. History/physical examination, including collection of weight and vital signs within 45 days prior to start of treatment.
7. MR of the rectum is mandatory for staging and follow-up.
8. Chest CT scan within 45 days prior to study entry.
9. Radiation treatment planning abdominal CT. A mandatory pelvic MR will be done as a simulation (SIM) (ideally with interpretation). The CT SIM will not be done with interpretation. Ability to undergo abdominal MR scans for staging and radiation planning and follow-up is mandatory.
10. Laboratory values (CBC, Chem24) 45 days prior to treatment as follows:
1. Carcinoembryonic antigen (CEA) (any value).
2. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3.
3.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT04808323, registered by Medical College of Wisconsin on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.