Clinical trial NCT05902533: REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation
Official title: REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Anal Cancer
Keywords: Toxicity Mitigation
Reduced Elective Nodal Dose
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm prospective trial.
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Assess Toxicity Index for all GI, GU, Dermatologic, and Hematologic CTCAE events from treatment initiation through 90 days post treatment
timeFrame: 90 days post treatment
measure: Assess patient reported GI toxicity using PRO-CTCAE Diarrhea
timeFrame: 9 weeks post treatment
Secondary outcomes:
measure: Colostomy-Free-Survival - measured by follow up without colostomy
timeFrame: 3 years (Patients followed 3 years post Treatment)
measure: Disease Free Survival measured by digital rectal exam
timeFrame: 3 and 6 months post treatment
measure: Local Regional Recurrence
timeFrame: 6 months post treatment
measure: Overall Survival - measured by survival or death at follow up
timeFrame: 3 years (Patients followed 3 years post Treatment)
measure: Proportion of patients requiring a treatment break due to toxicity; measured by more than 3 consecutive fractions missed.
timeFrame: Measured during the 5.5 - 6 week treatment period
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References: