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Active, Not Recruiting

NCT Number: NCT03018418

Proton Therapy in Reducing Toxicity in Anal Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anus Neoplasms Anus Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UC Health

Cincinnati, Ohio, 45044, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Karnofsky Performance Status >70%
  • Histologically documented squamous or basaloid carcinoma of the anal canal
  • Stage T2-4 disease with any N category

Exclusion criteria

  • Patients with a life expectancy of < 3 months.

Treatment and study plan

proton therapy

Radiation

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

Chemotherapy

Drug

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

Other names: 5FU, Mitomycin

Primary outcomes

  1. Rates of Acute Toxicity

    Time frame: 3 months

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

Secondary outcomes

  1. Rates of Late Toxicity

    Time frame: every 6 months up to 60 months

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

  2. Complete Response Rate

    Time frame: at 6 months from the completion of chemoradiation

    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.

  3. Local Progression Free Survival

    Time frame: every 6 months up to 60 months

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

  4. Overall Survival

    Time frame: every 6 months up to 24 months

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

  5. Distant Metastases Free Survival

    Time frame: every 6 months up to 60 months

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

  6. Quality of Life Changes

    Time frame: before treatment and 12 months after start of treatment

    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.

Sponsors and collaborators

Lead sponsor

Jordan Kharofa

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2025
First posted
Jan 12, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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