Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Fluorouracil

Mitomycins

Mitomycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy

Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions

Proton therapy

5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29

Chemotherapy

Jordan Kharofa, MD

The purpose of this research study is to determine whether the amount of radiation given to the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing the side effects that are seen with standard therapy.

Proton Therapy in Reducing Toxicity in Anal Cancer

A Prospective Pilot Study to Evaluate the Feasibility of Intensity Modulated Proton Therapy in Reducing Toxicity in Anal Cancer

Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity

Complete response was clinically determined by digital rectal examination and proctosigmoidoscopy supplemented with pelvic axial imaging. Biopsy was not required. The complete response was the absence of disease based on these evaluations. Any measurable disease at 6 months from the completion of chemoradiation will be considered a local treatment failure. Any tumor recurrence in the anus in patients who initially had a complete response will be considered a local recurrence.

This is the percentage of subjects that were free of local progression.

This is an estimated percentage of participants that is alive at 2 years.

This is the percentage of subjects that were free of distant metastases.

Utilization of the Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events at pretreatment and up to 12 months. This measure used the difference total score for each subject's baseline and latest PROCTCAE available. The reported statistic is the number of subjects that showed a reduction in scores between the two time points.

Jordan Kharofa

Assistant Professor

The definition does not differ from clinicaltrials.gov.

This is a summary of adverse events for all 14 subjects in the study.

Adverse Events for All 14 Subjects

Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy

Proton therapy: Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions

Chemotherapy: 5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29

Proton Therapy and Chemotherapy

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Subjects with grade 3+ Adverse events that fall within the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic

Grade 3+ Hematologic, Gastrointestinal, Genitourinary, and Dermatologic Toxicity

The population is the subjects that had at least one adverse event that was grade 3 or higher in one of the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic

Rates of Acute Toxicity

Rates of Late Toxicity

14 represents the total sample size of the study. 11 met complete clinical response at 6 months.

Subjects With Complete Response Rate

Complete Response Rate

This is the local progression free survival for 14 subjects.

Local Progression Free Survival for 14 Subjects

Local Progression Free Survival

time from the date of registration to the date of death due to all causes

Overall Survival for 14 Subjects

Overall Survival

Distant metastases free survival for 14 subjects

Distant Metastases Free Survival for 14 Subjects

Distant Metastases Free Survival

Utilization of the Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events at pretreatment, 2 weeks, 4 weeks, 3, 6, and 12 months

Quality of Life Changes for 14 Subjects

Quality of Life Changes

Patients with histologically confirmed squamous or basaloid carcinoma of the anal canal were eligible if they were at least 18 years old with a Karnofsky performance status \> 70%, AJCC eighth edition cT2-4 disease with any N category, life expectancy \>3 months, and acceptable organ and bone marrow function. Women who were not postmenopausal had to have a negative urine or serum pregnancy test. History and physical examination (including anal and groin evaluation) had to be performed within 21 days of trial registration.

Spots Global Cancer Trial Database for Proton Therapy in Reducing Toxicity in Anal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial