Proton therapy for Anal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
UC Health, Cincinnati, OH
Anal Cancer
Proton therapy - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether proton therapy may reduce the amount of radiation given to the normal areas around the anal cancer while reducing the side effects that are seen with standard therapy. original

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Proton therapy will improve 1 primary outcome and 6 secondary outcomes in patients with Anal Cancer. Measurement will happen over the course of 3 months.

3 months
Rates of acute toxicity
Month 12
Quality of Life Changes
Month 60
Complete response rate
Distant metastases free survival
Local progression free survival
Overall survival
Rates of late toxicity

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Proton Therapy and Chemotherapy
1 of 1
Experimental Treatment

This trial requires 14 total participants across 1 different treatment group

This trial involves a single treatment. Proton Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Proton Therapy and ChemotherapyStandard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton therapy
2011
N/A
~30
Mitomycin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: every 6 months up to 60 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly every 6 months up to 60 months for reporting.

Closest Location

UC Health - Cincinnati, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Karnofsky Performance Status >70%
Histologically documented squamous or basaloid carcinoma of the anal canal
Stage T2-4 disease with any N category

Patient Q&A Section

What is anal cancer?

"This is the first review of what the symptoms of anal cancer and how risky these symptoms are. There are no risk groups of patients. The risk of anal cancer is low, though as with any cancer there are risks if the cancer is missed. The symptoms of anal cancer are very similar to those of other types of cancer, most frequently the first symptoms of anal cancer are no change. Most anal cancers occur sporadically with no known hereditary cause; anal cancer is rare in patients with familial adenomatous polyposis and may be underdiagnosed in those with polyposis. Treating anal cancer is the same, by surgical resection or radiation +/- chemoradiotherapy." - Anonymous Online Contributor

Unverified Answer

What are the signs of anal cancer?

"In the early stages of this common disease, signs can be confused with other rectal diseases or benign conditions such as chronic anorectal inflammation, diverticulosis, and fistula." - Anonymous Online Contributor

Unverified Answer

What causes anal cancer?

"There is no compelling evidence yet to support the hypothesis that anal cancer exists as a distinct disease entity. Rather, the vast majority of cases diagnosed as, or as 'anal cancer', are in fact carcinoma of the anal canal. In many cases, this will be localized and amenable to radiotherapy. A small minority of cases are likely carcinoma inguinal lymph node or distant metastatic to the abdominal wall, hip bone, or brain. Anal cancer is rare. The cause of anal cancer remains unclear. It may be that there are multiple causes for anal cancer.\n\nThe prostate gland is an organ found near the top of the male reproductive system." - Anonymous Online Contributor

Unverified Answer

What are common treatments for anal cancer?

"There are many treatment options available to patients with anal cancer, including radiation, chemotherapy, chemotherapy and radiation, stents, surgery, and targeted agents. Many of these options can work and/or be used in combination. Anal cancer is also commonly treatable with surgery. However, in some people, surgical options have a limited benefit. Further research is needed to determine which options are most beneficial in specific individuals." - Anonymous Online Contributor

Unverified Answer

Can anal cancer be cured?

"There is no statistical proof for cure of anal cancer, neither after curative treatment according to the principles of surgery, surgery-related local therapy or radical surgery-related local therapy, after neoadjuvant necro-chemotherapy and irradiation, or after radiotherapy alone." - Anonymous Online Contributor

Unverified Answer

How many people get anal cancer a year in the United States?

"More than 11,000 people in the United States get anal cancer annually, with about half of all cases developing during adulthood. The risk of developing anal cancer increases with lifetime cumulative smoking, particularly among men. The American Colorectal Cancer Screening Consortium may be underutilized in identifying persons at risk for anal cancer." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving proton therapy?

"The most recent (2012-2014) large, multi-center clinical trial, PROACH-03, reported good outcomes for the proton beam therapy-based stereotactic body radiotherapy (SBRT) for nonmetastatic (≥ cT2aN0M0) anal cancer. To date, this is the only Phase 3 clinical trial of SBRT reported, although two other Phase 3 clinical trials evaluating SBRT for anal cancer had been completed by the same time. At least, one additional, multicenter clinical trial and a number of smaller clinical trials evaluating the efficacy of proton beam therapy for anal cancer, including SBRT and chemoradiation, have been completed during the past year." - Anonymous Online Contributor

Unverified Answer

What is proton therapy?

"There are different concepts of proton therapy that lead to the creation of proton therapy treatment plans. Although proton therapy is a rapidly growing technique, there is not yet one accepted treatment plan for all radiobiological conditions. Proton therapy dosimetry can be used to develop treatment plans specific for each individual patient. Treatment planning should be based on the individual plan geometry of the anatomical location treated and of the beam arrangement, and on individual dosimetry." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets anal cancer?

"[Based on an analysis of data from cancer and population studies published between 1990 and 2015, anal cancer occurs most frequently in men who are in their prime (30-54 years old)] in countries with high rates of infection and human immunodeficiency virus (HIV) /prostitutionsupportive healthcaresystems /or both. [source unknown]. [power?] question: Is high-grade squamous intraepithelial lesions diagnosed by colposcopy a risk factor for the development of invasive carcinoma? answer: Patients with multiple HGLE diagnosed during a colposcopy evaluation have a higher risk of subsequent invasive carcinoma compared with those who undergo colposcopy with abnormal colpectomy specimen only." - Anonymous Online Contributor

Unverified Answer

How does proton therapy work?

"Overall survival in anal cancer patients treated with proton irradiation is comparable to that in patients treated with IMRT and to that reported in the literature. Local control and rectal toxicity are also similar. Proton irradiation should be considered as an option for patients with anal cancer." - Anonymous Online Contributor

Unverified Answer

What is the latest research for anal cancer?

"This summary highlights key research findings that are relevant to anal cancer. Future studies should examine the potential role of the tumor microenvironment and the role of epigenetic processes in cancer development." - Anonymous Online Contributor

Unverified Answer

How serious can anal cancer be?

"The overall [five-year survival] rate of anal cancer was 81% ± 12%. The overall and disease-specific 10-year survival rates were 92% ± 11% and 84% ± 9%, respectively. Overall and disease-specific survival rates were higher in men than in women and were lower among all [age groups] as compared with the results of the U.S. [National Cancer Institute] Surveillance, Epidemiology, and End Results Study. [Age] ≥ 65 years was an independent prognostic factor for [all] survival; men over 50 years had a survival rate of 74%, less than those under 50 years." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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