- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04827732
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer (IMPARC)
August 21, 2023 updated by: Washington University School of Medicine
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hyun Kim, M.D.
- Phone Number: 314-362-8567
- Email: kim.hyun@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Sub-Investigator:
- Yi Huang, M.S.
-
Principal Investigator:
- Hyun Kim, M.D.
-
Sub-Investigator:
- Carl DeSelm, M.D., Ph.D.
-
Contact:
- Hyun Kim, M.D.
- Phone Number: 314-362-8567
- Email: kim.hyun@wustl.edu
-
Sub-Investigator:
- Re-I Chin, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
|
When feasible it is strongly recommended that radiotherapy begin on a Monday
Other Names:
-The device that will administer the IMPT
|
Experimental: Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
|
When feasible it is strongly recommended that radiotherapy begin on a Monday
Other Names:
-The device that will administer the IMPT
|
Experimental: Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
|
When feasible it is strongly recommended that radiotherapy begin on a Monday
Other Names:
-The device that will administer the IMPT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD) of reirradiation using hypofractionated IMPT
Time Frame: Through 6 months from start of treatment for all participants enrolled (estimated to be 42 months)
|
|
Through 6 months from start of treatment for all participants enrolled (estimated to be 42 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median overall survival (OS)
Time Frame: At 12 months post-radiation therapy (estimated to be 12 months and 1 week)
|
At 12 months post-radiation therapy (estimated to be 12 months and 1 week)
|
|
Median progression-free survival (PFS)
Time Frame: At 12 months post-radiation therapy (estimated to be 12 months and 1 week)
|
-Defined as time from end of radiation therapy to the earliest date of locoregional progression, distant progression, or death from any cause
|
At 12 months post-radiation therapy (estimated to be 12 months and 1 week)
|
Change in quality of life as measured by the EORTC QLQ-C30
Time Frame: Prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy
|
-The EORTC QLQ-C30 consists of a 30-question questionnaire, which assesses patient well-being with five functional scales (the physical, role, emotional, cognitive, social, and global).
It also includes three symptom scales (fatigue, pain, nausea/vomiting) and six single items (dyspnea, sleep disturbance, appetite loss, diarrhea, constipation, and financial impact).
Single-item QL scores for overall physical condition (question 29), overall quality of life (question 30), and the global and social functioning scales have been shown to be prognostic for overall survival in adult patients with advanced malignancies
|
Prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy
|
Change in quality of life as measured by the EORTC QLQ-CR29
Time Frame: Prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy
|
-The QLQ-CR29 contains 29 questions, including items in 4 scales (urinary frequency, blood/mucus in stools, stool frequency, body image) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest for men, sexual interest for women, impotence, dyspareunia).
There are 11 items allocated for specific sub-populations, including males, females, and stoma patients.
Scores of the QLQ-CR29 can be linearly transformed to provide a score from 0 to 100, with higher scores representing higher levels of functioning on the functional scales, greater degrees of symptomatology on the symptom scales and improved QOL on the global QOL scale
|
Prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy
|
Frequency of 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)
|
From start of treatment through 3 months after completion of radiation therapy (estimated to be 3 months and 1 week)
|
|
Frequency of 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
|
From 3 month post-completion of radiation therapy to 12 months post-completion of radiation therapy
|
|
Clinical complete response rate
Time Frame: Within 6 weeks to 3 months post-completion of radiation therapy (estimated to be 7 weeks to 3 months and 1 week))
|
-DRE, endoscopy, and cross sectional imaging will be used to measure clinical complete response rate
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Within 6 weeks to 3 months post-completion of radiation therapy (estimated to be 7 weeks to 3 months and 1 week))
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Median freedom from locoregional progression (FFLP)
Time Frame: At 12 months post-radiation therapy (estimated to be 12 months and 1 week)
|
-Defined as time from end of radiation therapy to date of first instance of local or regional tumor progression
|
At 12 months post-radiation therapy (estimated to be 12 months and 1 week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hyun Kim, M.D., Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 4, 2021
Primary Completion (Estimated)
November 30, 2024
Study Completion (Estimated)
May 31, 2025
Study Registration Dates
First Submitted
March 29, 2021
First Submitted That Met QC Criteria
March 29, 2021
First Posted (Actual)
April 1, 2021
Study Record Updates
Last Update Posted (Actual)
August 23, 2023
Last Update Submitted That Met QC Criteria
August 21, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202103218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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