Proton Therapy for Rectal Cancer Recurrence
(IMPARC Trial)
Recruiting in Palo Alto (17 mi)
Overseen byAllen Mo, M.D., Ph.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Washington University School of Medicine
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this trial is to determine the maximum tolerated dose (MTD) of hypofractionated IMPT for the reirradiation of locoregionally recurrent rectal cancer.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot be on any investigational agents.
What data supports the idea that Proton Therapy for Rectal Cancer Recurrence is an effective treatment?
The available research does not provide specific data on Proton Therapy for Rectal Cancer Recurrence. However, it does show that Proton Therapy, specifically Intensity-modulated Proton Therapy (IMPT), is being explored for other cancers like pancreatic, prostate, head and neck, and anal cancers. In these cases, Proton Therapy has been compared to other treatments and has shown potential benefits, such as lower side effects and improved targeting of cancer cells. This suggests that Proton Therapy could be effective for rectal cancer recurrence as well, but more specific research would be needed to confirm this.
12345What safety data is available for proton therapy in treating rectal cancer recurrence?
The safety data for proton therapy, including techniques like Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT), is primarily derived from studies on other cancers such as pancreatic, prostate, and anal cancers. These studies suggest that IMPT can improve the therapeutic ratio by better targeting tumors while sparing healthy tissue, potentially reducing acute and late toxicities. However, specific safety data for rectal cancer recurrence is not directly available in the provided research, indicating a need for further studies in this specific context.
14678Is Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy a promising treatment for rectal cancer recurrence?
Yes, Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) is promising because it allows for better dose distribution, which means it can target cancer cells more precisely while sparing healthy tissue. This makes proton therapy more accessible and potentially more effective for patients.
23569Eligibility Criteria
This trial is for adults who've had one round of radiation for rectal cancer and now have a recurrence in the pelvis. They must be generally fit (ECOG 0-2), able to consent, and use birth control if needed. Excluded are those with more than one prior pelvic radiation, other active cancers or serious illnesses, pregnant/breastfeeding women, or certain genetic conditions.Inclusion Criteria
My cancer in the rectum, anus, or rectosigmoid junction has come back in the pelvis.
I can take care of myself and perform daily activities.
I am 18 years old or older.
+3 more
Exclusion Criteria
I had cancer before, but it was treated over 2 years ago and I'm now cancer-free, or it was a minor skin cancer or cervical condition treated locally.
I do not have any ongoing infections or heart issues.
I have conditions like lupus or genetic mutations that make my tissues more sensitive to radiation.
+4 more
Participant Groups
The study tests how much of a new type of targeted proton therapy called hypofractionated IMPT can be given safely to treat recurrent rectal cancer. It uses advanced technology like MEVION S250i Hyperscan to deliver precise doses while minimizing damage to healthy tissue.
3Treatment groups
Experimental Treatment
Group I: Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)Experimental Treatment2 Interventions
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3.
* 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).
Group II: Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)Experimental Treatment2 Interventions
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2.
* 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).
Group III: Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)Experimental Treatment2 Interventions
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1.
* 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).
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) is already approved in United States, Japan, European Union for the following indications:
🇺🇸 Approved in United States as Proton Therapy for:
- Colorectal cancer
- Prostate cancer
- Liver cancer
- Esophageal cancer
- Pancreatic cancer
🇯🇵 Approved in Japan as Proton Therapy for:
- Colorectal cancer
- Prostate cancer
- Liver cancer
- Esophageal cancer
- Pancreatic cancer
🇪🇺 Approved in European Union as Proton Therapy for:
- Colorectal cancer
- Prostate cancer
- Liver cancer
- Esophageal cancer
- Pancreatic cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
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Who Is Running the Clinical Trial?
Washington University School of MedicineLead Sponsor
References
Initial experience with intensity modulated proton therapy for intact, clinically localized pancreas cancer: Clinical implementation, dosimetric analysis, acute treatment-related adverse events, and patient-reported outcomes. [2022]Pencil-beam scanning intensity modulated proton therapy (IMPT) may allow for an improvement in the therapeutic ratio compared with conventional techniques of radiation therapy delivery for pancreatic cancer. The purpose of this study was to describe the clinical implementation of IMPT for intact and clinically localized pancreatic cancer, perform a matched dosimetric comparison with volumetric modulated arc therapy (VMAT), and report acute adverse event (AE) rates and patient-reported outcomes (PROs) of health-related quality of life.
Helical tomotherapy vs. intensity-modulated proton therapy for whole pelvis irradiation in high-risk prostate cancer patients: dosimetric, normal tissue complication probability, and generalized equivalent uniform dose analysis. [2018]To compare intensity-modulated proton therapy (IMPT) and helical tomotherapy (HT) treatment plans for high-risk prostate cancer (HRPCa) patients.
Re-irradiation of recurrent head and neck carcinomas: comparison of robust intensity modulated proton therapy treatment plans with helical tomotherapy. [2021]To test the hypothesis that the therapeutic ratio of intensity-modulated photon therapy using helical tomotherapy (HT) for retreatment of head and neck carcinomas can be improved by robust intensity-modulated proton therapy (IMPT).
Hematologic Toxicity Comparison of Intensity Modulated Proton Therapy and Intensity Modulated Radiation Therapy in Anal Cancer Patients. [2023]We hypothesize that hematologic toxicity will be lower in anal cancer patients treated definitively with intensity modulated proton therapy (IMPT) compared with patients treated with intensity modulated radiation therapy (IMRT).
Radiotherapy treatment of early-stage prostate cancer with IMRT and protons: a treatment planning comparison. [2020]To compare intensity-modulated photon radiotherapy (IMRT) with three-dimensional conformal proton therapy (3D-CPT) for early-stage prostate cancer, and explore the potential utility of intensity-modulated proton therapy (IMPT).
Extreme hypofractionated proton radiotherapy for prostate cancer using pencil beam scanning: Dosimetry, acute toxicity and preliminary results. [2020]Extreme hypofractionated radiotherapy for prostate cancer is a common modality in photon therapy. Pencil beam scanning (PBS) in similar fractionation allows better dose distribution and makes proton therapy more available for such patients. The purpose of this study is the feasibility of extreme proton hypofractionated radiotherapy and publication of early clinical results.
Intensity modulated proton therapy. [2018]Intensity modulated proton therapy (IMPT) implies the electromagnetic spatial control of well-circumscribed "pencil beams" of protons of variable energy and intensity. Proton pencil beams take advantage of the charged-particle Bragg peak-the characteristic peak of dose at the end of range-combined with the modulation of pencil beam variables to create target-local modulations in dose that achieves the dose objectives. IMPT improves on X-ray intensity modulated beams (intensity modulated radiotherapy or volumetric modulated arc therapy) with dose modulation along the beam axis as well as lateral, in-field, dose modulation. The clinical practice of IMPT further improves the healthy tissue vs target dose differential in comparison with X-rays and thus allows increased target dose with dose reduction elsewhere. In addition, heavy-charged-particle beams allow for the modulation of biological effects, which is of active interest in combination with dose "painting" within a target. The clinical utilization of IMPT is actively pursued but technical, physical and clinical questions remain. Technical questions pertain to control processes for manipulating pencil beams from the creation of the proton beam to delivery within the patient within the accuracy requirement. Physical questions pertain to the interplay between the proton penetration and variations between planned and actual patient anatomical representation and the intrinsic uncertainty in tissue stopping powers (the measure of energy loss per unit distance). Clinical questions remain concerning the impact and management of the technical and physical questions within the context of the daily treatment delivery, the clinical benefit of IMPT and the biological response differential compared with X-rays against which clinical benefit will be judged. It is expected that IMPT will replace other modes of proton field delivery. Proton radiotherapy, since its first practice 50 years ago, always required the highest level of accuracy and pioneered volumetric treatment planning and imaging at a level of quality now standard in X-ray therapy. IMPT requires not only the highest precision tools but also the highest level of system integration of the services required to deliver high-precision radiotherapy.
Late Toxicity of Moderately Hypofractionated Intensity-Modulated Proton Therapy Treating the Prostate and Pelvic Lymph Nodes for High-Risk Prostate Cancer. [2023]To evaluate late gastrointestinal (GI) and genitourinary (GU) toxicity of moderately hypofractionated intensity modulated proton therapy (IMPT) targeting the prostate and pelvic lymph nodes.
Helical tomotherapy and intensity modulated proton therapy in the treatment of early stage prostate cancer: a treatment planning comparison. [2018]To compare helical tomotherapy (HT) and intensity modulated proton therapy (IMPT) on early stage prostate cancer treatments delivered with simultaneous integrated boost (SIB) in moderate hypofractionation.