Recurrent Rectal CancerIMPARCNCT04827732
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer
A study testing Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy and MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine in people with Recurrent Rectal Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this trial is to determine the maximum tolerated dose (MTD) of hypofractionated IMPT for the reirradiation of locoregionally recurrent rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Rectal Cancer
- What is being tested?
- Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy and MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2021to 18 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of biopsy-proven adenocarcinoma of the rectum, anus or rectosigmoid junction of any stage now with recurrent disease in the pelvis
- One prior course of radiation therapy to the pelvis for rectal cancer
- ECOG performance status 0-2
- At least 18 years of age
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Able to understand and willing to sign an IRB-approved written informed consent document.
Who cannot join
- Patients with pre-existing radiosensitizing conditions, such as connective tissue disorders (i.e. lupus, scleroderma) and genetic mutations (i.e. ataxia-telangiectasia)
- A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease, basal cell or squamous cell carcinoma of the skin that were treated with local resection only, or carcinoma in situ of the cervix. Patients with history of prostate cancer treated without radiotherapy and no evidence of disease are eligible
- More than one prior course of radiation to the pelvis for rectal cancer
- Prior radiation to the pelvis for disease other than rectal cancer
- Tumor in the rectum/colon requiring radiation therapy to the full circumference of the rectum/colon.
- Current treatment with any investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or unstable angina pectoris
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in the Reirradiation of Locoregionally Recurrent Rectal Cancer - IMPARC
The purpose of this trial is to determine the maximum tolerated dose (MTD) of hypofractionated IMPT for the reirradiation of locoregionally recurrent rectal cancer.
- Conditions
- Recurrent Rectal Cancer
- Being tested
- Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy, MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton TherapyRadiation
Also called IMPT
When feasible it is strongly recommended that radiotherapy begin on a Monday
MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy MachineDevice
-The device that will administer the IMPT
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) | Experimental | * Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime). Receives: Radiation: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy; Device: MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine |
| Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) | Experimental | * Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime). Receives: Radiation: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy; Device: MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine |
| Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) | Experimental | * Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime). Receives: Radiation: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy; Device: MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine |
| Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) | Experimental | * Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime). Receives: Radiation: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy; Device: MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Reirradiation Using Hypofractionated IMPT
- MTD is defined as the dose associated with a 35% probability of dose-limiting toxicity (DLT).
- DLT is defined as any toxicity listed below that occurs within 6 months from start of treatment and is considered possibly, probably, or definitely related to proton reirradiation:
- Any grade 5 toxicities
- Any grade 4-5 GI toxicities
- Bowel obstruction
- Grade 3-5: diarrhea; anal, colonic, or bowel ulcers; bladder perforation; any fistula formations; peripheral motor/sensory neuropathy of the pelvis above baseline; osteonecrosis/soft tissue necrosis; radiation dermatitis; hematuria; hematochezia; bowel/pelvic hemorrhage; reproductive tract toxicity
- Toxicity will be graded using CTCAE v5
Measured: From start of treatment through 6 months
Secondary outcomes (10)
Clinical Complete Response Rate
-DRE, endoscopy, and cross-sectional imaging will be used to measure clinical complete response rate
Measured: Within 6 weeks to 3 months post-completion of radiation therapy (range 7-14 weeks)
Median Freedom From Locoregional Progression (FFLP)
-Defined as time from end of radiation therapy to date of first instance of local or regional tumor progression
Measured: Through completion of follow-up (full range 1.81 months-13.87 months)
Median Overall Survival (OS)
Defined as time from end of radiation therapy to date that at least 50% of patients died
Measured: Through completion of follow-up (full range 4.4 months to 13.87 months)
Median Progression-free Survival (PFS)
-Defined as time from end of radiation therapy to the earliest date of locoregional progression, distant progression, or death from any cause
Measured: Through completion of follow-up (full range 1.81 months-13.87 months)
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
30 question survey which assesses patient well-being with 5 functional scales, 9 symptom scales, \& global health scale. Scores for each scale range from 0-100. Higher score for the functional scale \& global health represent high functioning, while high score for symptom scale represents high symptomatology. Median scores were taken for each scale for each dose level and the different between pre-treatment and post-treatment scores were calculated to determine change in score over time. For functional scales and global health status, negative values represent improved functionality/quality of life, while positive values represent diminished functionality. For symptom scales, the opposite is true. If patients did not complete the the survey at each time point, their data was censored. Data values were averaged prior to 3 months. Differences were taken between baseline values and the average value calculated of post-RT up to 3 months.
Measured: Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
30 question survey which assesses patient well-being with 5 functional scales, 9 symptom scales, \& global health scale. Scores for each scale range from 0-100. Higher score for the functional scale \& global health represent high functioning, while high score for symptom scale represents high symptomatology. Median scores were taken for each scale for each dose level and the different between pre-treatment and post-treatment scores were calculated to determine change in score over time. For functional scales and global health status, negative values represent improved functionality/quality of life, while positive values represent diminished functionality. For symptom scales, the opposite is true. If patients did not complete the survey at each time point, their data was censored. Data values were averaged from 3-12 months. Differences were taken between baseline values and the average value calculated of post-RT from 3-12 months.
Measured: Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
29 question survey which assesses quality of life for patients with colorectal cancer including functional \& symptom status. The survey includes 4 multi-item scales \& 19 single-item scales. Scores are linearly transformed to provide a score from 0-100. A high score for functional scales represents high level of functioning, while a high score for symptom scale represents high level of symptoms. Median scores were taken for each scale \& the difference between baseline \& varying time points was reported. Negative value represents improved function for a functional scale item, \& worsening symptoms for symptom scale items. Positive values represent the converse. If patients did not complete the survey at each time point, their data was censored. Data values were averaged prior to 3 months. Differences were taken between pre-treatment (baseline) values and the average value calculated of post-RT up to 3 months.
Measured: Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
29 question survey which assesses quality of life for patients with colorectal cancer including functional \& symptom status. The survey includes 4 multi-item scales \& 19 single-item scales. Scores are linearly transformed to provide a score from 0-100. A high score for functional scales represents high level of functioning, while a high score for symptom scale represents high level of symptoms. Median scores were taken for each scale \& the difference between baseline \& varying time points was reported. Negative value represents improved function for a functional scale item, \& worsening symptoms for symptom scale items. Positive values represent the converse. If patients did not complete the survey at each time point, their data was censored. Data values were averaged from 3-12 months. Differences were taken between baseline values and the average value calculated of post-RT from 3-12 months
Measured: Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Measured: From start of treatment through 3 months after completion of radiation therapy (estimated to be 3 months and 1 week)
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Measured: From 3 month post-completion of radiation therapy to 12 months post-completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start4 May 2021
- Primary completion29 Jul 2024
- Study completion18 Nov 2024
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Rectal CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Waters, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827732
- Sponsor's protocol ID
- 202103218
- Acronym
- IMPARC
- Status last verified
- Sep 2025
- First submitted
- 29 Mar 2021
- Last updated
- 29 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in the Reirradiation of Locoregionally Recurrent Rectal Cancer - IMPARC
- ClinicalTrials.gov ID
- NCT04827732
- Acronym / sponsor ID
- IMPARC / 202103218
- Conditions
- Recurrent Rectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 11 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to determine the maximum tolerated dose (MTD) of hypofractionated IMPT for the reirradiation of locoregionally recurrent rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) | Experimental | Radiation: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy, Device: MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy). * The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime). |
| Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) | Experimental | Radiation: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy, Device: MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy). * The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime). |
| Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) | Experimental | Radiation: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy, Device: MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy). * The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime). |
| Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) | Experimental | Radiation: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy, Device: MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy). * The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- History of biopsy-proven adenocarcinoma of the rectum, anus or rectosigmoid junction of any stage now with recurrent disease in the pelvis
- One prior course of radiation therapy to the pelvis for rectal cancer
- ECOG performance status 0-2
- At least 18 years of age
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Key exclusion criteria (8 listed)
- Patients with pre-existing radiosensitizing conditions, such as connective tissue disorders (i.e. lupus, scleroderma) and genetic mutations (i.e. ataxia-telangiectasia)
- A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease, basal cell or squamous cell carcinoma of the skin that were treated with local resection only, or carcinoma in situ of the cervix. Patients with history of prostate cancer treated without radiotherapy and no evidence of disease are eligible
- More than one prior course of radiation to the pelvis for rectal cancer
- Prior radiation to the pelvis for disease other than rectal cancer
- Tumor in the rectum/colon requiring radiation therapy to the full circumference of the rectum/colon.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton TherapyAlso: IMPTWhen feasible it is strongly recommended that radiotherapy begin on a Monday | Radiation | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT), Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT), Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT), Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
| MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine-The device that will administer the IMPT | Device | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT), Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT), Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT), Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
Primary outcome
Maximum Tolerated Dose (MTD) of Reirradiation Using Hypofractionated IMPT
Time frame: From start of treatment through 6 months
* MTD is defined as the dose associated with a 35% probability of dose-limiting toxicity (DLT). * DLT is defined as any toxicity listed below that occurs within 6 months from start of treatment and is considered possibly, probably, or definitely related to proton reirradiation: * Any grade 5 toxicities * Any grade 4-5 GI toxicities * Bowel obstruction * Grade 3-5: diarrhea; anal, colonic, or bowel ulcers; bladder perforation; any fistula formations; peripheral motor/sensory neuropathy of the pelvis above baseline; osteonecrosis/soft tissue necrosis; radiation dermatitis; hematuria; hematochezia; bowel/pelvic hemorrhage; reproductive tract toxicity * Toxicity will be graded using CTCAE v5
10 secondary outcomes
Clinical Complete Response Rate
Time frame: Within 6 weeks to 3 months post-completion of radiation therapy (range 7-14 weeks)
Median Freedom From Locoregional Progression (FFLP)
Time frame: Through completion of follow-up (full range 1.81 months-13.87 months)
Median Overall Survival (OS)
Time frame: Through completion of follow-up (full range 4.4 months to 13.87 months)
Median Progression-free Survival (PFS)
Time frame: Through completion of follow-up (full range 1.81 months-13.87 months)
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Time frame: Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Time frame: Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Time frame: From start of treatment through 3 months after completion of radiation therapy (estimated to be 3 months and 1 week)
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Time frame: From 3 month post-completion of radiation therapy to 12 months post-completion of radiation therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Waters, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy and MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine in people with Recurrent Rectal Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Reirradiation Using Hypofractionated IMPT (time frame: From start of treatment through 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.