Adaptive radiation therapy for anal cancer

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 pilot study aims to evaluate the feasibility of dose-adapted radiation therapy for patients with locally advanced anal squamous cell carcinoma. It involves 20 patients and focuses on daily adaptation of radiation plans based on changes in tumor size and patient anatomy during treatment. By utilizing advanced imaging techniques, the study seeks to maximize radiation delivery to the tumor while minimizing exposure to surrounding healthy tissues. The approach includes the use of chemotherapy agents alongside radiation therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically proven, invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal.
* American Joint Committee on Cancer (AJCC) 8th edition stage T2 \> 4 cm, T3-4 or N1.
* Age ≥18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%).
* Life expectancy of greater than 12 months.
* Patients must have normal organ and marrow function as defined below:
* leukocytes greater than or equal to 3,000/microliter
* absolute neutrophil count greater than or equal to 1,500/microliter
* platelets greater than or equal to 100,000/microliter
* total bilirubin within normal institutional limits
* Aspartate transaminase (AST)(SGOT)/Alanine transaminase (ALT)(SGPT) ≤ 2.5 × institutional upper limit of normal
* creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
* Females of childbearing potential and males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after completion of study therapy. All pregnancies must be reported.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Prior or co-existing invasive malignancy (except non-melanomatous skin cancer) unless disease free ≥ 2 years.
* Prior chemotherapy or radiation for anal cancer.
* Patients who have undergone complete surgical resection.
* Presence of recurrent/metastatic disease.
* Prior allergic reaction to 5-Fluorouracil or mitomycin C.
* Artificial organ prosthetics, pacemakers or other implantable devices.
* Prior radiotherapy to the pelvis that would result in overlap of radiation therapy fields.
* Uncontrolled inter-current illness including but not limited to known history of HIV with cluster of differentiation 4 (CD4) count less than 200 or symptomatic cardiac disease.
* Women who are pregnant or lactating.

Where it's running

• Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Lisa Kachnic, MD — Principal Investigator
• Study coordinator: Christina Chesnakov
• Email: cc4047@cumc.columbia.edu
• Phone: 646-317-4244

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

• EVOLVE104 for advanced bladder and other squamous cell cancers

  This will try EVOLVE104, an experimental drug, in adults with advanced or metastatic bladder or other squamous cell cancers who have already tried or cannot take standard treatments.

  Recruiting at 16 sites Phase 1 EvolveImmune United, Inc · Duarte, California and 15 other locations · NCT07217171

• High resolution anal examination for HPV and anal cancer detection

  This study is testing how well high-resolution anal exams can help find high-risk HPV and anal cancer in people who are more likely to have these issues.

  Recruiting Universitair Ziekenhuis Brussel · Jette · NCT06697964

• MR-guided radiation therapy for anal cancer with tailored treatment

  This study is testing a personalized radiation therapy approach for patients with anal cancer to see if adjusting treatment based on their individual risk levels and biomarkers can improve their outcomes.

  Recruiting Phase 2 University Health Network, Toronto · Pittsburgh, Pennsylvania and 4 other locations · NCT06050707

• Daily online adaptive radiotherapy for anal cancer

  This study is testing if daily online adaptive radiotherapy can help people with anal cancer experience less stomach problems compared to standard radiation treatment.

  Recruiting Herlev Hospital · Herlev · NCT05438836

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.