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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

INSPIRE Trial Summary

This trial aims to see if treating anal canal cancer without radiation to the groin is as effective as with it, and also if it causes fewer side effects.

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.Check my eligibility

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.See study design

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.

INSPIRE Trial 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.

INSPIRE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease free survival (DFS)

Incidence of inguinal lymph node recurrence

Secondary outcome measures

Exercise Behavior and Physical Fitness

Health related Quality of Life (EORTC QLQ-AN27)

Health related Quality of Life (EORTC QLQ-C30)

+6 more

Other outcome measures

Relationship between radiotherapy treatment planning variables and acute toxicity.

INSPIRE 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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor

182 Previous Clinical Trials

36,167 Total Patients Enrolled

Kurian Joseph, MDPrincipal InvestigatorAHS-CCI

1 Previous Clinical Trials

10 Total Patients Enrolled

Media Library

Chemo-Radiation Treatment (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05040815 — Phase 2

Anal Cancer Research Study Groups: chemo-radiation treatment

Anal Cancer Clinical Trial 2023: Chemo-Radiation Treatment Highlights & Side Effects. Trial Name: NCT05040815 — Phase 2

Chemo-Radiation Treatment (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05040815 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA endorse chemo-radiation as a viable treatment option?

"According to our team at Power, the safety of chemo-radiation treatment is rated a 2 due to it being in Phase 2 trials and having available data on its security but not yet proving efficacy."

Answered by AI

What is the overall size of this trial's patient cohort?

"Affirmative. According to the clinicaltrials.gov website, this research project was introduced on May 11th of 2023 and is still actively recruiting participants. As such, 45 individuals are needed from one site for successful completion."

Answered by AI

Are there any open slots for those wishing to join this trial?

"True, the details on clinicaltrials.gov attest that this medical study is actively recruiting patients. It was initially posted on May 11th 2023 and its parameters were recently revised on May 12th of the same year. 45 people need to be sourced from a single location for this experiment."

Answered by AI

What primary objective is this research endeavor attempting to accomplish?

"This clinical trial will span 36 months, during which time the primary outcome of interest is ascertaining incidence of inguinal lymph node recurrence. Secondary objectives include Health Related Quality of Life (IIEF) for male participants evaluated using International Index of Erectile Function at baseline and 3 month intervals post-treatment; Treatment-Related Acute Toxicities assessed based on NCI CTCAE v5.0 criteria weekly throughout treatment and three months after completion thereof; as well as Health Related Quality Of Life (EORTC QLQ-C30) utilizing European Organization For The Research And Treatment Of Cancer's Quality Of Life Questionnaire"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer

2023. "Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05040815.

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