Anus NeoplasmsPhase 2NCT03018418
Proton Therapy in Reducing Toxicity in Anal Cancer
A Phase 2 study testing Proton therapy and Chemotherapy in people with Anus Neoplasms, run by Jordan Kharofa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anus Neoplasms
- What is being tested?
- Proton therapy and Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2017to 1 Jul 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Karnofsky Performance Status >70%
- Histologically documented squamous or basaloid carcinoma of the anal canal
- Stage T2-4 disease with any N category
Who cannot join
- Patients with a life expectancy of < 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Pilot Study to Evaluate the Feasibility of Intensity Modulated 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.
- Conditions
- Anus Neoplasms
- Being tested
- Proton therapy, Chemotherapy
- Keywords
- Anal Cancer
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton therapyRadiation
Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions
ChemotherapyDrug
Also called 5FU, Mitomycin
5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29
| Study group | Role | What they receive |
|---|---|---|
| Proton Therapy and Chemotherapy | Experimental | Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy Receives: Radiation: Proton therapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Acute Toxicity
Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
Measured: 3 months
Secondary outcomes (6)
Rates of Late Toxicity
Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
Measured: every 6 months up to 60 months
Complete Response Rate
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.
Measured: at 6 months from the completion of chemoradiation
Local Progression Free Survival
This is the percentage of subjects that were free of local progression.
Measured: every 6 months up to 60 months
Overall Survival
This is an estimated percentage of participants that is alive at 2 years.
Measured: every 6 months up to 24 months
Distant Metastases Free Survival
This is the percentage of subjects that were free of distant metastases.
Measured: every 6 months up to 60 months
Quality of Life Changes
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.
Measured: before treatment and 12 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start4 Jan 2017
- Primary completion7 Apr 2022
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anus NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Kharofa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jordan Kharofa, University of Cincinnati
- Investigators
- Jordan Kharofa, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018418
- Sponsor's protocol ID
- UCCI-GI-16-01
- Status last verified
- Aug 2024
- First submitted
- 10 Jan 2017
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study to Evaluate the Feasibility of Intensity Modulated Proton Therapy in Reducing Toxicity in Anal Cancer
- ClinicalTrials.gov ID
- NCT03018418
- Acronym / sponsor ID
- UCCI-GI-16-01
- Conditions
- Anus Neoplasms
- Keywords
- Anal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Jordan KharofaUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Posted 5 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Therapy and Chemotherapy | Experimental | Radiation: Proton therapy, Drug: ChemotherapyStandard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Karnofsky Performance Status >70%
- Histologically documented squamous or basaloid carcinoma of the anal canal
- Stage T2-4 disease with any N category
Key exclusion criteria (1 listed)
- Patients with a life expectancy of < 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton therapyPrimary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions | Radiation | Proton Therapy and Chemotherapy |
| ChemotherapyAlso: 5FU, Mitomycin5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29 | Drug | Proton Therapy and Chemotherapy |
Primary outcome
Rates of Acute Toxicity
Time frame: 3 months
Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
6 secondary outcomes
Rates of Late Toxicity
Time frame: every 6 months up to 60 months
Complete Response Rate
Time frame: at 6 months from the completion of chemoradiation
Local Progression Free Survival
Time frame: every 6 months up to 60 months
Overall Survival
Time frame: every 6 months up to 24 months
Distant Metastases Free Survival
Time frame: every 6 months up to 60 months
Quality of Life Changes
Time frame: before treatment and 12 months after start of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Kharofa, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proton therapy and Chemotherapy in people with Anus Neoplasms, run by Jordan Kharofa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Acute Toxicity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.