RecruitingPHASE2INTERVENTIONAL

Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer

This study is for people with early-stage anal cancer. The usual treatment involves chemotherapy and radiation to the whole pelvis, including the groin area. We're testing a new approach where we avoid radiating the groin if special scans and tests (called sentinel node biopsy and PET-CT) show no cancer there. We think this might lead to fewer side effects like skin irritation and swelling, and improve patients' quality of life, while still being just as good at treating the cancer. Researchers also want to check if this new approach causes fewer side effects and helps people live better lives. This is a Phase 2 study, which means it's an earlier-stage trial testing safety and how well it works before it can be widely used.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

AHS Cancer Control Alberta

Enrolment target

Start

11 May 2023

Estimated completion

01 May 2028

Anal Canal Cancer

What is this study about?

When people have early anal cancer, the usual treatment involves a combination of chemotherapy and radiation therapy. This powerful treatment often includes radiating the groin area to make sure any tiny, unseen cancer cells are destroyed, even if they aren't obvious on scans. While this method is very good at controlling the cancer, radiating such a large area can cause quite a few side effects, both immediately and sometimes years later. These can include skin irritation, fatigue, and swelling.

Doctors are always looking for ways to make cancer treatments more effective and gentler. In this study, we're exploring if we can avoid radiating the groin area in certain patients with early-stage anal cancer. We'll use special tests, called a sentinel node biopsy (SLNB) and PET-CT scans, to get a very clear picture of whether cancer has spread to the groin lymph nodes. If these tests show no signs of cancer in the groin, we believe it might be safe to skip groin radiation for these patients.

Our hope is that by avoiding radiation to the groin, patients will experience fewer side effects and have a better quality of life during and after treatment. This study will closely monitor patients to ensure that this new approach is just as effective at treating the cancer as the current standard. If successful, it could change how early anal cancer is treated in the future, making treatment kinder for many.

Key takeaways

This study explores a gentler approach to treating early anal cancer.
It aims to reduce treatment side effects by avoiding radiation to the groin area.
Special tests determine if groin radiation can be safely skipped.
Researchers will compare this new method to standard treatment.
The goal is to improve quality of life for patients while effectively treating cancer.
Participation involves strict monitoring and check-ups.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a specific type of early anal cancer that hasn't spread beyond the local area. Importantly, special scans and tests must show no signs of cancer in your groin lymph nodes.

You should also be well enough for chemotherapy, meaning your liver, kidneys, and bone marrow are working properly. If you've had cancer before, it needs to be a very mild skin cancer or a cancer that was successfully treated more than five years ago. Women who could become pregnant will need a negative pregnancy test and agree to use effective birth control during the study. Men should also agree not to donate sperm.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I at least 18 years old?
Do I have anal canal cancer that hasn't spread to other body parts?
Do my scans and tests show no cancer in my groin lymph nodes?
Am I healthy enough for chemotherapy and radiation?
Am I willing to use effective birth control if I can have children?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive chemotherapy and radiation treatment for your anal cancer. The main difference is that, depending on your test results, you might not receive radiation to your groin area. You will have regular check-ups, scans, and tests throughout the treatment and for a period afterwards to monitor your progress and check for any side effects. The exact number of visits and tests will be explained in detail by the study team. You'll also be asked about your quality of life regularly to see how the treatment affects you.

Potential risks and benefits

The potential benefits of joining this study include receiving treatment that might lead to fewer side effects like skin problems and swelling in the groin, potentially improving your quality of life. However, as this is a new approach, there's always a small chance that avoiding groin radiation could lead to the cancer returning in that area, though we will be monitoring you very closely. Like all cancer treatments, chemotherapy and radiation have known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Cross Cancer Institute
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is anal canal cancer?

Anal canal cancer is a type of cancer that starts in the cells of the anal canal, which is the short tube at the end of your large bowel.

What is 'chemo-radiation'?

Chemo-radiation is a combination treatment that uses both chemotherapy (medication to kill cancer cells) and radiation therapy (high-energy rays to kill cancer cells) at the same time.

What does 'inguinal node sparing' mean?

This means trying to avoid giving radiation to the lymph nodes in your groin area (called inguinal nodes) if special tests show there's no cancer there.

What is a 'sentinel node biopsy'?

A sentinel node biopsy is a procedure where a doctor finds and removes the first lymph node(s) to which cancer cells are most likely to spread. These nodes are then checked for cancer.

Why is avoiding groin radiation important?

Avoiding radiation to the groin might reduce common side effects like skin irritation, swelling, and discomfort in that area, potentially improving your comfort and quality of life.

How to find out more

Kurian Joseph, MD

kurian.joseph@ahs.ca 780-432-8755 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.