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Anal CancerPhase 2/3REDELNCT05902533

REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation

A Phase 2/3 study testing Radiation (reduced elective nodal dose (30.6 Gy), Capecitabine and Mitomycin c in people with Anal Cancer, run by University of Cincinnati at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To determine the efficacy of reduced elective nodal radiation in anal cancer patients undergoing chemoradiation in reducing toxicity compared to standard nodal irradiation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anal Cancer
What is being tested?
Radiation (reduced elective nodal dose (30.6 Gy), Capecitabine and Mitomycin c
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
3 sitesUnited States
Study dates
14 Aug 2023to 14 Aug 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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

  • Age ≥18 years.
  • Patients must have stage T1-4N+M0 or T3/T4N0M0 locally advanced anal cancer as evidenced by a PET scan AND either a CT with contrast of the abdomen/pelvis or an MRI with contrast of the pelvis. All imaging must be from within 60 days prior to registration.
  • Note: Patients with T2N0 disease will be allowed if the primary tumor is >4 cm. Patients with Stage I-T1N0M0 or Stage II-T2N0M0 (tumor ≤ 4cm) will be ineligible for participation.
  • Patients with perianal cancer that is HPV associated (P16+) will be eligible if the tumor extends to the anal verge and the CTV will include the mesorectal, internal/external iliac, and inguinal lymph nodes.
  • Patients with excision of the primary tumor but with node positive disease or residual disease at the primary if T3T4N0 will be eligible.
  • ECOG performance status 0 or 1 (or Karnofsky ≥70, see Appendix A).
Show all 9Show fewer
  • Patients must be able to receive concurrent treatment with capecitabine and Mitomycin C in the opinion of the investigator.
  • Creatinine Clearance must be > 30 ml/min.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Any prior pelvic radiation.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine.
  • Patients with uncontrolled intercurrent illness that in the opinion of the investigator would prevent receipt of radiation or capecitabine.
  • Note: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • Pregnant or breastfeeding women are excluded from this study.
  • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the investigator.
  • Patients with active autoimmune or connective tissue disease requiring systemic treatment are excluded from this study.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Vermont

    Burlington, Vermont, 05405

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

To determine the efficacy of reduced elective nodal radiation in anal cancer patients undergoing chemoradiation in reducing toxicity compared to standard nodal irradiation.

Read the detailed description

This is a multi-center, single arm prospective trial to evaluate whether reduced elective nodal dose (30.6 Gy) reduces toxicity as defined by the CTCAE Toxicity Index compared to historic patients treated with standard nodal dose on NRG/RTOG0529 and patient reported GI toxicity using the validated PRO-CTCAE scale for diarrhea compared to historic patients treated on UC-GI-1601.

Conditions
Anal Cancer
Being tested
Radiation (reduced elective nodal dose (30.6 Gy), Capecitabine, Mitomycin c
Keywords
Toxicity Mitigation, Reduced Elective Nodal Dose
Medical subject headings
Anus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation (reduced elective nodal dose (30.6 Gy)Radiation

    28-30 fractions Monday through Friday of intended chemoradiation depending on the total dose required (50.4-54 Gy) which will occur over approximately 5.5 to 6 weeks.

  • CapecitabineDrug

    825 mg/m2 BID (Oral Twice daily on days with RT)

  • Mitomycin cDrug

    10 mg/m2 slow IV push Day 1 and 29

Study groups in NCT05902533
Study groupRoleWhat they receive
Reduced Elective Dose + Concurrent Capecitabine/Mitomycin CExperimentalReduced elective nodal dose (30.6 Gy); (28- 30 fractions given M-F for approximately 5.5 to 6 weeks) Capecitabine 825 mg/m2 BID on days with RT Mitomycin C 10 mg/m2 slow IV push Days 1 and 29
Receives: Radiation: Radiation (reduced elective nodal dose (30.6 Gy); Drug: Capecitabine; Drug: Mitomycin c

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess Toxicity Index for all GI, GU, Dermatologic, and Hematologic CTCAE events from treatment initiation through 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.

    Measured: 90 days post treatment

  2. Assess patient reported GI toxicity using PRO-CTCAE Diarrhea

    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%.

    Measured: 9 weeks post treatment

Secondary outcomes (5)

  1. Colostomy-Free-Survival - measured by follow up without colostomy

    Colostomy-Free-Survival - Time from treatment completion to any colostomy or last follow up without colostomy.

    Measured: 3 years (Patients followed 3 years post Treatment)

  2. Disease Free Survival measured by digital rectal exam

    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.

    Measured: 3 and 6 months post treatment

  3. Local Regional Recurrence

    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.

    Measured: 6 months post treatment

  4. Overall Survival - measured by survival or death at follow up

    Overall Survival - Time from registration to death or last follow up

    Measured: 3 years (Patients followed 3 years post Treatment)

  5. Proportion of patients requiring a treatment break due to toxicity; measured by more than 3 consecutive fractions missed.

    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.

    Measured: Measured during the 5.5 - 6 week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start14 Aug 2023
  3. Primary completion14 Aug 2026 (estimated)
  4. Study completion14 Aug 2029 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm prospective trial.
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05902533
Sponsor's protocol ID
UCCC-GI-23-01
Acronym
REDEL
Status last verified
Dec 2025
First submitted
5 Jun 2023
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Radiation (reduced elective nodal dose (30.6 Gy), Capecitabine and Mitomycin c in people with Anal Cancer, run by University of Cincinnati at 3 sites 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 9 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Assess Toxicity Index for all GI, GU, Dermatologic, and Hematologic CTCAE events from treatment initiation through 90 days post treatment (time frame: 90 days post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05902533.

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 18 Dec 2025.

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