What side effects are associated with this type of intervention?

Common treatments for anal cancer, such as radiation therapy and chemotherapy, can cause side effects including skin irritation, fatigue, bowel dysfunction (e.g., diarrhea, proctitis), urinary issues, nausea, vomiting, hair loss, and increased risk of infections. The trial on avoiding preventative radiation aims to reduce these side effects by minimizing unnecessary radiation exposure, potentially improving the patient's quality of life.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for treatments of anal cancer that focus on avoiding preventative radiation. Generally, the standard treatment for anal cancer often includes chemoradiation, combining chemotherapy (such as 5-fluorouracil and mitomycin) with radiation therapy. The trial mentioned aims to reduce radiation exposure to minimize side effects and maintain quality of life, which is an evolving area of research. Current FDA-approved treatments do not specifically focus on reducing radiation exposure but rather on the efficacy of combined chemoradiation.

What other types of research exist?

Promising novel alternatives to avoidance of preventative radiation for anal cancer patients include: 1) Immunotherapy, which leverages the body's immune system to target cancer cells, potentially reducing the need for radiation. 2) Targeted therapy, which uses drugs to specifically target cancer cell mechanisms, minimizing damage to healthy tissue. 3) Advanced surgical techniques, such as minimally invasive surgery, which can reduce the need for extensive radiation. 4) Personalized medicine approaches, which tailor treatment plans based on the genetic profile of the tumor, potentially reducing the reliance on radiation.

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Radiation Therapy

Node-Sparing Chemo-Radiation for Anal Cancer (INSPIRE Trial)

Phase 2

Recruiting

Led By Kurian Joseph, MD

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient should have histologically proven primary squamous cell carcinoma

No inguinal nodal involvement confirmed by PET imaging and SLNB

Must not have

T1N0 patients going for primary surgery

Prior radiation therapy to the pelvis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if skipping certain radiation treatments is as effective as giving them for early-stage anal cancer patients without lymph node involvement. The goal is to reduce side effects and improve quality of life.

Who is the study for?

This trial is for adults over 18 with early-stage anal cancer (T1-3 N0 M0) who haven't had pelvic radiation, chemotherapy, or surgery for it except biopsy. They must be able to consent and have a good performance status. Women can't be pregnant/breastfeeding and must test negative for pregnancy; men agree not to donate sperm. All participants should commit to effective birth control and have no other health issues that could affect the study.

What is being tested?

The study tests if avoiding groin radiation in patients with normal sentinel node biopsies and PET-CT scans is as effective as preventative groin radiation in treating anal canal cancer. It also examines whether this approach reduces side effects and improves quality of life.

What are the potential side effects?

While specific side effects are not listed, sparing the inguinal nodes from radiotherapy may reduce potential skin irritation, lymphedema (swelling due to fluid retention), sexual dysfunction, bowel complications, or urinary problems compared to standard treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed to be squamous cell carcinoma.

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My scans show no cancer in the groin lymph nodes.

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

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I am not breastfeeding while receiving study treatment.

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My breast cancer is in the early stages and has not spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a T1N0 patient planning to have my first surgery.

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I have had radiation therapy to my pelvic area before.

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I have had surgery or chemotherapy for anal cancer.

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I have had surgery for anal cancer, not including biopsy.

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My cancer has spread to distant parts of my body.

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My cancer is not squamous cell carcinoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease free survival (DFS)

Incidence of inguinal lymph node recurrence

Secondary study objectives

Exercise Behavior and Physical Fitness

Health related Quality of Life (EORTC QLQ-AN27)

Health related Quality of Life (EORTC QLQ-C30)

+6 more

Other study objectives

Relationship between radiotherapy treatment planning variables and acute toxicity.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: chemo-radiation treatmentExperimental Treatment1 Intervention

Radiotherapy with concurrent 5-fluorouracil and mitomycin-C combination treatment. Radiotherapy consists of 5400 cGy delivered in 30 fractions over 6 weeks. The investigators will be using the current standard regimen for the study or no change in the current CCI treatment regimen. However, the radiotherapy target will be smaller than current practice since the investigators will be omitting prophylactic inguinal irradiation.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for anal cancer include radiation therapy and chemotherapy. Radiation therapy works by using high-energy rays to target and kill cancer cells, while chemotherapy uses drugs to destroy cancer cells or stop them from growing. These treatments are often combined to enhance their effectiveness. The trial on avoiding preventative radiation aims to reduce radiation exposure to the groin area, which can minimize side effects such as skin irritation, bowel dysfunction, and sexual health issues, thereby maintaining a better quality of life for patients. This approach is particularly important for anal cancer patients, as it seeks to balance effective cancer control with the reduction of treatment-related toxicity.