Reduced radiation dose for anal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a reduced elective nodal radiation dose of 30.6 Gy in patients with anal cancer undergoing chemoradiation. It is a multi-center, single-arm prospective trial that aims to compare the toxicity levels experienced by participants to those of historical patients treated with standard nodal doses. The study will assess toxicity using the CTCAE Toxicity Index and patient-reported outcomes for gastrointestinal toxicity. The goal is to determine if the reduced dose can mitigate side effects while maintaining treatment efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Cincinnati Medical Center
  Cincinnati, Ohio, United States Recruiting
• Ohio State University Medical Center
  Columbus, Ohio, United States Recruiting
• University of Vermont
  Burlington, Vermont, United States Recruiting

Study contacts

• Study coordinator: UCCC Clinical Trials Office
• Email: cancer@uchealth.com
• Phone: 513-584-7698

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Retifanlimab after chemoradiation for anal cancer

  This study tests whether retifanlimab can help people with anal squamous cell carcinoma who have completed chemoradiation and still have residual disease.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07927998

• Irreversible Electroporation for Recurrent Pelvic Tumors

  This study tests whether using irreversible electroporation (IRE) is safe and helps control recurrent pelvic tumors in adults who can’t have other local treatments.

  Recruiting Amsterdam UMC, location VUmc · Amsterdam, North Holland · NCT07782164

• HPV DNA-guided chemoradiation with Retifanlimab for locally advanced anal cancer

  This study tests whether adjusting chemoradiation doses based on HPV ctDNA results and adding Retifanlimab after CRT can improve outcomes for adults with new, locally advanced anal cancer.

  Recruiting Phase 2 Case Comprehensive Cancer Center · Cleveland, Ohio and 1 other locations · NCT07425054

• Gynecological and sexual health after radiotherapy for anal cancer.

  See if vaginal problems and changes in sexual health are linked to radiation dose in women treated with chemoradiotherapy for anal cancer 6–36 months after treatment.

  Recruiting at 3 sites Aarhus University Hospital · Aarhus and 2 other locations · NCT07296237

• Self-sampling to improve anal lesion outcomes

  This study will test whether people at higher risk for anal cancer will use a self-collected anal swab and whether that increases follow-up cytology and high-resolution anoscopy (HRA) appointment attendance.

  Recruiting at 3 sites Medical College of Wisconsin · Chicago, Illinois and 2 other locations · NCT07192055

• Testing trastuzumab deruxtecan (T‑DxD) for HER2‑positive advanced solid tumors

  This will test whether trastuzumab deruxtecan (T‑DxD) helps adults in the US with HER2‑positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have had prior systemic treatment and have no satisfactory alternative options.

  Recruiting at 18 sites AstraZeneca · Birmingham, Alabama and 17 other locations · NCT07124000

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.