Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT) as a Component o… (NCT03690921) | Clinical Trial Compass
CompletedPhase 2
Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT) as a Component of Definitive Chemoradiation for Newly Diagnosed Squamous Cell Carcinoma of the Anal Canal: a Feasibility Trial
United States8 participantsStarted 2018-11-08
Plain-language summary
This phase II trial studies the side effects of LET-IMPT and standard chemotherapy, and how well they work in treating patients with newly diagnosed stage I-III anal canal squamous cell cancer. LET-IMPT is a type of radiation therapy that uses high energy proton "beamlets" to "paint" the radiation dose into the target and may help to kill tumor cells and shrink tumors. Giving LET-IMPT and standard chemotherapy may work better in treating patients with anal canal squamous cell cancer.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Histologically-proven, non-metastatic invasive primary squamous cell carcinoma of the anal canal (stages I, II, and III)
* History/physical examination including documentation of the primary anal lesion size, distance from the anal verge and anal sphincter tone within 60 days prior to registration
* Anal examination with biopsy on either colonoscopy, sigmoidoscopy, rigid proctoscopy or anoscopy
* Computed tomography (CT) scan of the chest and abdomen with contrast or contrast-enhanced positron emission tomography (PET)/CT scan within 60 days of registration unless the patient has a documented contrast allergy
* CT scan of pelvis with contrast or contrast-enhanced PET/CT scan within 60 days of registration unless the patient has a documented contrast allergy
* Zubrod performance status of 0-1 within 60 days prior to registration
* Absolute neutrophil count (ANC) \>=1.8 K/ul, cannot be achieved through granulocyte-colony stimulating factor (GCSF) (within 30 days prior to study registration)
* Platelets \>= 100 K/uL, cannot be achieved through transfusion (within 30 days prior to study registration)
* Hemoglobin \>= 8 g/dL, cannot be achieved through transfusion (within 30 days prior to study registration)
* Serum creatinine =\< 1.5 mg/dL (within 30 days prior to study registration)
* Bilirubin =\< 1.4 mg/dL, except in the case of patients with Gilbert's disease (within 30 days prior to study registration)
* White blood cells (WBC) \>= 3000/microliter (wit…
What they're measuring
1
Acute Toxicity
Timeframe: Acute physician reported toxicity from start of treatment 12 weeks post-treatment