Trial · NCT05902533
REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation
NCT05902533, Phase 2, Phase 3, Active not recruiting, University of Cincinnati
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation. Trials, record NCT05902533. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05902533
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation
- NCT number
- NCT05902533
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 33 participants, estimated
- Lead sponsor
- University of Cincinnati
- Conditions
- Anal Cancer
- Interventions
- Radiation (reduced elective nodal dose (30.6 Gy), Capecitabine, Mitomycin c
- First posted
- 2023-06-15
- Last updated
- 2025-12-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess Toxicity Index for all GI, GU, Dermatologic, and Hematologic CTCAE events from treatment initiation through 90 days post treatment | 90 days post treatment | Toxicity Index for all GI, GU, Dermatologic, and Hematologic CTCAE events from treatment initiation through 90 days post treatment. In patients treated with IMRT enrolled to NRG/RTOG 0529, the mean GI/GU/Derm/Hem TI was 3.858 (SD=0.892) assessed during this time period with standard nodal dose using a simultaneous integrated boost technique. Thirty-three patients will allow an effect size of 0.4 with 80% power and one-sided alpha of 0.05. This effect size is larger than the difference in toxicity observed compared to the historic standard of 3D-conformal radiation with IMRT (current standard) and thus felt to represent a clinically meaningful difference. The CTCAE Toxicity index will be determined for all Dermatologic, Gastrointestinal, Genitourinary, and hematologic events within 90 days from treatment initiation that are possible, probably, or definitely attributable to treatment. |
| Primary | Assess patient reported GI toxicity using PRO-CTCAE Diarrhea | 9 weeks post treatment | PRO-CTCAE Diarrhea will be used to assess patient reported GI toxicity for the primary endpoint at weeks 3, 5, and 9 (approximately 1-month post-treatment). Any high grade PRO-CTCAE Diarrhea (frequently/almost constantly) in week 3-9 was reported in 71% of patients on a prior trial in this population (UC-GI-1601) with standard nodal dose. With n=33 at alpha =0.05 (actual alpha=0.033) and power=0.80, we can detect a reduction in the proportion of patients reporting any PRO-CTCAE high grade diarrhea (week 3, 5, 9) of at least 22.3%. |
| Secondary | Colostomy-Free-Survival - measured by follow up without colostomy | 3 years (Patients followed 3 years post Treatment) | Colostomy-Free-Survival - Time from treatment completion to any colostomy or last follow up without colostomy. |
| Secondary | Disease Free Survival measured by digital rectal exam | 3 and 6 months post treatment | Disease Free Survival - Failure to achieve complete response (CR) at 6 months or subsequent recurrence. There will be a documented clinical response assessment of the primary anal tumor primarily by using digital rectal exam at 3 and 6 months to define clinical complete response along with a review of imaging at 6 months. Any residual tumor at 6 months would be considered "failure to achieve a complete response" and would be considered a DFS event. Resolution of the primary tumor after chemoradiation and recurrence of tumor (any size) would be considered a DFS event. Persistence of disease in grossly enlarged lymph node (GTV Gross Nodes) at 6 months or resolution and then recurrence (any size) would be considered DFS event. New lesions in the elective nodal space or any other location will be considered a DFS event. |
| Secondary | Local Regional Recurrence | 6 months post treatment | Local Regional Recurrence - All failures within the PTVs for the primary tumor, for the involved Lymph Nodes, or for the Elective Lymph Nodes, including both patients who failed to achieve CR at 6 months and those occurring more than 6 months after completion of chemoradiation after initial CR. |
| Secondary | Overall Survival - measured by survival or death at follow up | 3 years (Patients followed 3 years post Treatment) | Overall Survival - Time from registration to death or last follow up |
| Secondary | Proportion of patients requiring a treatment break due to toxicity; measured by more than 3 consecutive fractions missed. | Measured during the 5.5 - 6 week treatment period | Treatment breaks- The proportion of patients requiring a treatment break due to toxicity (more than 3 consecutive fractions missed) will be monitored and reported. In RTOG 0529, 50% of patients treated with standard nodal dose required a treatment break. |
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.
Grants0
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.
None in this release.
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/NCT05902533
GET https://conductscience.org/api/trials/v1/NCT05902533/registered