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Adaptive Radiation in Anal Cancer

Feasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study of 20 adults tests whether radiation plans can be changed each day to treat anal cancer that has grown nearby. Daily changes may help give more radiation to the tumor and less to nearby healthy organs.

This is a 20 patient pilot study to examine the feasibility of dose-adapted radiation therapy for the treatment of locally advanced anal squamous cell cancer. The tumor and a patient's anatomy may change during radiation treatment and daily adaption of the radiation plan (i.e., a new daily plan based on the anatomy of the day) may help to maximize the dose to the tumor and minimize the radiation dose to the normal surrounding organs.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have anal canal cancer confirmed by a tissue test. Allowed types are squamous, basaloid, or cloacogenic cancer that has grown into nearby tissue.
  • Have cancer at stage T2 with a tumor larger than 4 cm, T3–T4, or N1. These stages describe the tumor’s size, growth, or spread to nearby lymph nodes.
  • Be able to care for yourself and be out of bed or a chair for at least half the day.
  • Be expected to live more than 12 months.
  • Have blood cell counts and liver and kidney test results that meet the study’s limits.
  • If you can become pregnant or are male, agree to use birth control or avoid sex before joining, during the study, and for 6 months after treatment. Report all pregnancies.
  • Be able to understand the study and willing to sign a consent form.

Who can't join

  • Have another cancer that has grown into nearby tissue, now or in the past, unless cancer-free for at least 2 years. Non-melanoma skin cancer is allowed.
  • Have had chemotherapy or radiation for anal cancer, or surgery that removed all of the cancer.
  • Have anal cancer that has come back or spread to distant parts of the body.
  • Have had an allergic reaction to 5-fluorouracil or mitomycin C.
  • Have an artificial organ, pacemaker, or another device placed inside the body.
  • Have had radiation to the pelvis that would overlap with the planned treatment area.
  • Have an uncontrolled illness, including HIV with a CD4 immune cell count below 200 or heart disease causing symptoms.
  • Be pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

NY