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 range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested LET-optimized proton therapy — sometimes called IMPT — combined with chemotherapy for anal canal squamous cell carcinoma, and it already finished enrolling; can you tell me what the acute toxicity results showed, and whether that data suggests this approach caused more or fewer short-term side effects compared to standard radiation?
2Since this was a Phase 2 feasibility trial, the main goal was checking whether the treatment approach was practical and safe rather than proving it extends survival — does that mean there's still not enough evidence to know if LET-optimized proton therapy is better than conventional chemoradiation for my stage of anal cancer?
3The trial covered Stages I through III anal canal squamous cell carcinoma — given my specific stage, do you think the findings from this study are relevant to my situation, and would proton therapy even be a realistic option at the treatment centers available to me?
4Proton therapy isn't available everywhere, so if this approach looks promising based on the trial results, what would it actually take for me to access it — do you think I should pursue it now, or would starting with standard chemoradiation first make more sense for my case?
5The trial focused on acute toxicity, meaning side effects during and shortly after treatment — are there longer-term side effects or outcomes for anal cancer patients that this study wouldn't yet tell us about, and how should I factor that uncertainty into my decision?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute Toxicity

Timeframe: Acute physician reported toxicity from start of treatment 12 weeks post-treatment

Trial details

NCT IDNCT03690921

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-03

Results submitted2023-05-08

View on ClinicalTrials.gov More Anal Canal Squamous Cell Carcinoma trials