Adaptive Radiotherapy for the Treatment of Patients with Locally Advanced Anal Cancer

Status: active

This clinical trial tests the effect of adaptive planning during radiation therapy (radiotherapy) on radiation dose to normal organs and side effects in patients with anal squamous cell cancer that has spread to nearby tissue or lymph nodes (locally advanced). The standard treatment for locally advanced anal cancer is radiation given at the same time as chemotherapy. Radiation therapy (RT) uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Intensity-modulated radiation therapy (IMRT), a type of 3 dimensional radiation therapy, uses computer images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of RT reduces the damage to healthy tissue near the tumor. Adaptive radiation adjusts the radiation treatment plan every day so that any changes in the position or size of the tumor and the position of healthy organs and tissues can be taken into account. Adaptive radiotherapy may decrease radiation to healthy tissue and reduce side effects in patients with locally advance anal cancer.

Inclusion Criteria

Histologically proven, invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal
American Joint Committee on Cancer (AJCC) 8th edition TN stage T2 > 4 cm, T3-4 or N1; based upon the following diagnostic workup: physical exam; anal examination by one of the following: anoscopy, sigmoidoscopy, rigid proctoscopy or colonoscopy; biopsy confirmation required prior to enrollment, and CT scan, MRI, or PET/CT scan of the abdomen/pelvis. The listed work-up is standard of care
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Life expectancy of greater than 12 months
Leukocytes ≥ 3,000/mcL
Absolute neutrophil count ≥ 1,500/mcL
Platelets >= 100,000/mcL
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Study treatments are teratogenic or abortogenic; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of study therapy
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-FU, capecitabine, mitomycin C, or cisplatin
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. Patients with HIV that have measurable viral load and low CD4 count are eligible as long as they meet the other hematologic criteria in the eligibility list
Women who are pregnant or lactating

PRIMARY OBJECTIVE:

I. The primary outcome of this pilot trial is the time it takes to plan and deliver adaptive treatment fractions.

SECONDARY OBJECTIVES:

I. Acute treatment toxicity.

II. Clinical complete response at 6 months.

III. 2-year disease-free, colostomy-free, metastasis-free and overall survival.

IV. 2-year late treatment toxicity.

V. Analysis of dosimetric data to target structures and organs at risk for daily-adapted plans compared to the unadapted “base” plan.

VI. Assessment of physician decision-making process during the adaptive radiotherapy process.

OUTLINE:

Patients undergo image guided IMRT once daily (QD) Monday - Friday for 6 weeks. Patients also receive standard of care mitomycin intravenously (IV) or cisplatin IV on days 1 and 29 and fluorouracil IV on days 1-4 and 29-32 or capecitabine orally (PO) twice daily (BID) during radiation therapy. Additionally, patients undergo computed tomography (CT) scans, positron emission tomography (PET)/CT scans, magnetic resonance imaging (MRI) scans, blood sample collection, digital rectal examination (DRE), anoscopy, and sigmoidoscopy, rigid proctoscopy or colonoscopy throughout the study.

After completion of study treatment, patients are followed up following their last treatment date as indicated by the treating physician, and then every 3 months for up to 2 years.

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Adaptive Radiotherapy for the Treatment of Patients with Locally Advanced Anal Cancer

Inclusion Criteria

Exclusion Criteria

United States

New York

New York

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Adaptive Radiotherapy for the Treatment of Patients with Locally Advanced Anal Cancer

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