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Intensity-Modulated Radiation Therapy for Anal Cancer

Northwell Health/Center for Advanced Medicine, Lake Success, NY
Anal Cancer+5 More ConditionsIntensity-Modulated Radiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying how well lower-dose chemotherapy + radiation works to treat patients with early-stage anal cancer, compared to standard-dose chemoradiation.

Eligible Conditions
  • Stage IIA Anal Cancer
  • Anal Basaloid Carcinoma
  • Anal Squamous Cell Carcinoma
  • Anal Cancer
  • Stage I Anal Cancer
  • Anal Canal Cloacogenic Carcinoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

2 Primary · 17 Secondary · Reporting Duration: Up to 5 years

Baseline
Utility of image features of inguinal and pelvic lymph nodes obtained prior to treatment
Year 1
Change in FIQoL in the de-intensified CRT arm
Month 12
Change in serum total testosterone
Year 5
Changes in patient-reported outcomes - Anal Discomfort/pain (PROMIS- Full)
Changes in patient-reported outcomes - Fecal Incontinence Severity Index [FISI]
Changes in patient-reported outcomes - HRQL: Health Related Quality of Life FACT-G (Functional Assessment of Cancer Therapy-General)
Changes in patient-reported outcomes - International Index of Erectile Function [IIEF]: Erectile Dysfunction and Ejaculation Frequency.
Changes in patient-reported outcomes - Orgasm ability/pleasure (PROMIS-Brief)
Changes in patient-reported outcomes - Satisfaction with sex life (PROMIS-Brief)
Changes in patient-reported outcomes - Sexual Function-Vaginal Changes Questionnaire [SVQ]
Changes in patient-reported outcomes - Therapeutic Aids for Sexual Function - Female.
Changes in patient-reported outcomes - Therapeutic Aids for Sexual Function - Male.
Changes in patient-reported outcomes - Vaginal Assessment Scale [VAS]/Vulvar Assessment Scale [VuAS]
Up to 2 years
Disease control in the de-intensified chemoradiation therapy (CRT) arm
Up to 5 years
Disease control
Effect of interactive educational tool (eContour)
Effect of vaginal dilator use during radiation delivery on sexual function
Fluorouracil
Overall survival
Patterns of failure (local and regional relapse versus distant; in-field versus out-of-field of radiation)

Trial Safety

Phase-Based Safety

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

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

Arm A (standard-dose chemoradiation)
1 of 2
Arm B (de-intensified chemoradiation)
1 of 2

Active Control

Experimental Treatment

252 Total Participants · 2 Treatment Groups

Primary Treatment: Intensity-Modulated Radiation Therapy · No Placebo Group · Phase 2

Arm B (de-intensified chemoradiation)Experimental Group · 6 Interventions: Intensity-Modulated Radiation Therapy, Fluorouracil, Questionnaire Administration, Quality-of-Life Assessment, Capecitabine, Mitomycin · Intervention Types: Radiation, Drug, Other, Other, Drug, Drug
Arm A (standard-dose chemoradiation)ActiveComparator Group · 6 Interventions: Intensity-Modulated Radiation Therapy, Fluorouracil, Questionnaire Administration, Quality-of-Life Assessment, Capecitabine, Mitomycin · Intervention Types: Radiation, Drug, Other, Other, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~1680
Fluorouracil
FDA approved
Capecitabine
FDA approved
Mitomycin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,272 Previous Clinical Trials
41,230,476 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
110 Previous Clinical Trials
173,442 Total Patients Enrolled
Jennifer A DorthPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Virginia100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "I have anal prolapse sometimes"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

What are the potential adverse effects of receiving Intensity-Modulated Radiation Therapy?

"The safety of Intensity-Modulated Radiation Therapy was given a rating of 2, as clinical trials thus far have provided evidence that it is safe but not yet proven to be effective." - Anonymous Online Contributor

Unverified Answer

What medical conditions can be treated through Intensity-Modulated Radiation Therapy?

"Intensity-Modulated Radiation Therapy is a viable treatment option for those suffering from head and neck carcinoma, cervical cancers, and glaucoma." - Anonymous Online Contributor

Unverified Answer

How many geographical locations are administering this trial?

"This investigation is being conducted at Marshfield Medical Center-EC Cancer Centre in Eau Claire, Wisconsin; Munson Medical Center in Traverse City, Michigan; and Kootenai Clinic Cancer Services - Post Falls in Post Falls, Idaho. There are 100 other locations participating as well." - Anonymous Online Contributor

Unverified Answer

Has Intensity-Modulated Radiation Therapy been investigated in other trials?

"The number of live studies for Intensity-Modulated Radiation Therapy stands at 620 with 211 trials in Phase 3. Woolloongabba, Queensland is the epicenter of this research activity, yet 25537 locations globally are conducting related clinical studies." - Anonymous Online Contributor

Unverified Answer

Is it still feasible for individuals to enroll in this clinical experiment?

"Affirmative. Clinicaltrials.gov details that this medical trial, which was established on November 12th 2019, is actively looking for participants. 252 individuals are needed from 100 different sites to complete the study." - Anonymous Online Contributor

Unverified Answer

How many participants is the research team looking to recruit for this experiment?

"In order to advance this clinical trial, 252 patients meeting the specified requirements must be enrolled. Current locations for participants include Marshfield Medical Center-EC Cancer Centre in Eau Claire, Wisconsin and Munson Medical Centre in Traverse City, Michigan." - 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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