Trial · NCT04166318
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
NCT04166318, Phase 2, Active not recruiting, ECOG-ACRIN Cancer Research Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study. Trials, record NCT04166318. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04166318
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
- NCT number
- NCT04166318
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 252 participants, estimated
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Conditions
- Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma, Anal Canal Squamous Cell Carcinoma, Anal Margin Squamous Cell Carcinoma, Stage I Anal Cancer AJCC v8, Stage IIA Anal Cancer AJCC v8
- Interventions
Biopsy, Biospecimen Collection, Capecitabine, Computed Tomography, Fludeoxyglucose F-18, Fluorouracil, Intensity-Modulated Radiation Therapy, Magnetic Resonance Imaging, Mitomycin, Positron Emission Tomography, Quality-of-Life Assessment, Questionnaire Administration
- First posted
- 2019-11-18
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease control in the de-intensified chemoradiation therapy (CRT) arm | Up to 2 years | An event is local-regional failure, distant metastasis and chemoradiation-related death. Will determine if de-intensified chemoradiation achieves 2-year disease control of 85% or higher while improving anorectal health-related quality of life (HRQL), compared to standard-dose CRT, as measured by the change in the Fecal Incontinence Quality of Life scale (FIQoL) instrument coping/behavior domain from baseline to 1 year. The co-primary endpoints of disease control and FIQoL will be formally assessed in a hierarchical manner with disease control being assessed first. Will be estimated for all treatment arms using the Kaplan-Meier method (1958). |
| Primary | Change in FIQoL in the de-intensified CRT arm | Baseline up to 1 year | Quality of life analyses, will be compared between arms using a two-sample independent t-tests at a significance level of 0.05 and appropriate longitudinal models will be evaluated to assess the trajectory of HRQL endpoints over time and to evaluate those trajectories between treatment arms. Overall score and change from baseline will be summarized using mean and standard deviation at each time point for each arm. |
| Secondary | Changes in patient-reported outcomes | Baseline up to 5 years | Will compare changes as per Fecal Incontinence Severity Index \[FISI\], Patient Reported Outcomes Measurement Information System \[PROMIS\], International Index of Erectile Function \[IIEF\], Sexual Function-Vaginal Changes Questionnaire \[SVQ\], and Vaginal Assessment Scale \[VAS\]/Vulvar Assessment Scale \[VuAS\] instruments between the experimental and control arm. Quality of life analyses, will be compared between arms using a two-sample independent t-tests at a significance level of 0.05 and appropriate longitudinal models will be evaluated to assess the trajectory of HRQL endpoints over time and to evaluate those trajectories between treatment arms. Overall score and change from baseline will be summarized using mean and standard deviation at each time point for each arm. |
| Secondary | Patterns of failure (local and regional relapse versus distant; in-field versus out-of-field of radiation) | Up to 5 years | Will be compared between experimental and control arm. The cumulative incidence method will be used to estimate local-regional and distant failure rates and the failure rates for the experimental treatment will be compared against the control using a failure specific log rank test. |
| Secondary | Disease control | Up to 5 years | Will be compared between experimental and control arm. Will be estimated for all treatment arms using the Kaplan-Meier method (1958). |
| Secondary | Effect of vaginal dilator use during radiation delivery on sexual function | Up to 5 years | Vaginal dilator use during radiation delivery will be correlated with sexual function. |
| Secondary | Change in serum total testosterone | Baseline up to 12 months after radiation | |
| Secondary | Utility of image features of inguinal and pelvic lymph nodes obtained prior to treatment | Baseline | Will be validated as a prognostic indicator that can identify patients with early-stage anal squamous cell carcinoma for whom treatment with de-intensified CRT is appropriate. |
| Secondary | Incidence of and predictors for cardiovascular toxicity in patients receiving fluorouracil or capecitabine | Up to 5 years | Rates of grade 3+ adverse events (Common Terminology Criteria for Adverse Events \[CTCAE\], version \[v.\] 5) will be estimated using a binomial distribution along with their associated 95% confidence intervals and compared using Fisher's exact test between arms. |
| Other | Overall survival | Up to 5 years | Will be compared between experimental and control arm. Will be estimated for all treatment arms using the Kaplan-Meier method (1958). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04166318
GET https://conductscience.org/api/trials/v1/NCT04166318/registered