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Trial Title:
REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation
NCT ID:
NCT05902533
Condition:
Anal Cancer
Conditions: Official terms:
Anus Neoplasms
Capecitabine
Mitomycins
Mitomycin
Conditions: Keywords:
Toxicity Mitigation
Reduced Elective Nodal Dose
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single arm prospective trial.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiation (reduced elective nodal dose (30.6 Gy)
Description:
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.
Arm group label:
Reduced Elective Dose + Concurrent Capecitabine/Mitomycin C
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
825 mg/m2 BID (Oral Twice daily on days with RT)
Arm group label:
Reduced Elective Dose + Concurrent Capecitabine/Mitomycin C
Intervention type:
Drug
Intervention name:
Mitomycin c
Description:
10 mg/m2 slow IV push Day 1 and 29
Arm group label:
Reduced Elective Dose + Concurrent Capecitabine/Mitomycin C
Summary:
To determine the efficacy of reduced elective nodal radiation in anal cancer patients
undergoing chemoradiation in reducing toxicity compared to standard nodal irradiation.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years.
2. 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.
1. 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.
2. 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.
3. Patients with excision of the primary tumor but with node positive disease or
residual disease at the primary if T3T4N0 will be eligible.
3. ECOG performance status 0 or 1 (or Karnofsky ≥70, see Appendix A).
4. Patients must be able to receive concurrent treatment with capecitabine and
Mitomycin C in the opinion of the investigator.
5. Creatinine Clearance must be > 30 ml/min.
6. Ability to understand and the willingness to sign a written informed consent
document.
Exclusion Criteria:
1. Any prior pelvic radiation.
2. History of allergic reactions attributed to compounds of similar chemical or
biologic composition to capecitabine.
3. Patients with uncontrolled intercurrent illness that in the opinion of the
investigator would prevent receipt of radiation or capecitabine.
a. Note: HIV-infected patients on effective anti-retroviral therapy with
undetectable viral load within 6 months are eligible for this trial.
4. Pregnant or breastfeeding women are excluded from this study.
5. 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.
6. Patients with active autoimmune or connective tissue disease requiring systemic
treatment are excluded from this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Cincinnati Medical Center
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Vollmer
Phone:
513-213-3203
Email:
mccordce@ucmail.uc.edu
Investigator:
Last name:
Jordan Kharofa, MD
Email:
Principal Investigator
Facility:
Name:
University of Vermont
Address:
City:
Burlington
Zip:
05405
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emma Armstrong
Phone:
802-656-2178
Email:
emma.armstrong@uvmhealth.org
Investigator:
Last name:
Chris Anker, MD
Email:
Principal Investigator
Start date:
August 14, 2023
Completion date:
August 14, 2029
Lead sponsor:
Agency:
University of Cincinnati
Agency class:
Other
Source:
University of Cincinnati
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05902533
