NCT03018418

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 5, 2023

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

5.3 years

First QC Date

January 10, 2017

Results QC Date

May 11, 2023

Last Update Submit

August 21, 2024

Conditions

Anus Neoplasms

Keywords

Anal Cancer

Outcome Measures

Primary Outcomes (1)

  • Rates of Acute Toxicity

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

    3 months

Secondary Outcomes (6)

  • Rates of Late Toxicity

    every 6 months up to 60 months

  • Complete Response Rate

    at 6 months from the completion of chemoradiation

  • Local Progression Free Survival

    every 6 months up to 60 months

  • Overall Survival

    every 6 months up to 24 months

  • Distant Metastases Free Survival

    every 6 months up to 60 months

  • +1 more secondary outcomes

Study Arms (1)

Proton Therapy and Chemotherapy

EXPERIMENTAL

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

Radiation: Proton therapyDrug: Chemotherapy

Interventions

Proton therapyRADIATION

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

Proton Therapy and Chemotherapy
ChemotherapyDRUG

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

Also known as: 5FU, Mitomycin
Proton Therapy and Chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with a life expectancy of \< 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Health

Cincinnati, Ohio, 45044, United States

Location

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Proton TherapyDrug TherapyFluorouracilMitomycin

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeuticsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Jordan Kharofa, MD
Organization
University of Cincinnati Cancer Center
kharofjr@ucmail.uc.edu
513-584 4775

Study Officials

  • Jordan Kharofa, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 12, 2017

Study Start

January 4, 2017

Primary Completion

April 7, 2022

Study Completion

July 1, 2025

Last Updated

September 19, 2024

Results First Posted

October 5, 2023

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)