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Anal Canal CancerPhase 2INSPIRENCT05040815

Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer

A Phase 2 study testing chemo-radiation treatment in people with Anal Canal Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to see whether avoiding preventative radiation to the groin in patients with normal sentinel node biopsy and PET-CT, is at least as effective treating cancer as giving preventative radiation to the groin for patients with anal canal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anal Canal Cancer
What is being tested?
chemo-radiation treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteCanada
Study dates
11 May 2023to May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants capable of giving informed consent.
  • Patients must be 18 years of age or older.
  • Patient should have histologically proven primary squamous cell carcinoma.
  • Patients must have early AC, Stage T1-3 N0 M0.
  • No inguinal nodal involvement confirmed by PET imaging and SLNB.
  • No history of prior malignancy other than non-melanoma skin cancer or other malignancy with disease free survival ≥ 5 years.
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  • Performance status ECOG 0-2 / Zubrod performance status ≥70.
  • Patient should be eligible for concomitant chemotherapy (e.g. adequate hepatic, renal and bone marrow function).
  • Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause.
  • Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly (Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard).
  • Females must not breastfeed during study treatment.
  • Male patients should agree to not donate sperm during study treatment.
  • Absence of any condition hampering compliance with study protocols and follow-up schedule; those conditions should be reviewed with the patient prior to trial registration.

Who cannot join

  • T1N0 patients going for primary surgery
  • Prior radiation therapy to the pelvis.
  • Pregnancy or lactation.
  • Prior surgical treatment for anal cancer other than biopsy.
  • Prior surgical or chemotherapy treatment for anal cancer.
  • Evidence of distant metastases.
  • Comorbid medical conditions precluding radical treatment at the discretion of Oncologist.
  • Histology other than squamous cell carcinoma or variants.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kurian Joseph, MD contact

780-432-8755

kurian.joseph@ahs.ca

Canada1 site, 1 recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Kurian Joseph, MD

    Recruiting

Other trials in Canada

About this study

Official title: A Prospective Phase II Study of Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer (INSPIRE)

The purpose of this study is to see whether avoiding preventative radiation to the groin in patients with normal sentinel node biopsy and PET-CT, is at least as effective treating cancer as giving preventative radiation to the groin for patients with anal canal cancer.

The investigators also want to know if avoiding radiation to the groin will cause fewer side effects and better quality of life

Read the detailed description

Radiotherapy (RT) with concurrent 5-fluorouracil and mitomycin-C (5FU/MMC) combination is the treatment of choice for non-metastatic locally advanced anal squamous cell carcinoma (ASCC). While, locally advanced AC treatment involves elective inguinal lymph node irradiation along with concurrent chemotherapy with significant improvement of locoregional control and colostomy free survival, many oncologists believe that routine, elective irradiation of bilateral inguinal areas of patients with limited disease (T1-T3) without lymph node involvement may be overtreatment and the larger radiation target that includes entire pelvis and bilateral inguinal region causes significant acute and late toxicities.

SLNB is the standard procedure currently used for breast cancer staging. The most significant observation was that when the SLN is negative, no further ALND or adjuvant axillary radiation is need for those patients. The SLNB had shown a better diagnostic accuracy (31% vs.25%) and higher sensitivity (85% vs.75%) than FDG-PET imaging to detect inguinal lymph node metastasis. Given better diagnostic accuracy and high sensitivity of SLNB, this technique could be used precisely to define target population who could be spared of prophylactic inguinal irradiation.

The investigators hypothesize that patients with early clinical stage node negative anal cancer (T1-T3N0) have low risk of subclinical inguinal lymph node involvement that can be detected by a combination of PET imaging and SLNB. Hence, any early stage AC patients with node negative disease confirmed by PET imaging and SLNB have relatively low risk of nodal failure and so inguinal radiation could be avoided. This approach would limit over treatment of early stage patients, reduce acute and late toxicities. This will be tested in a phase II study with close follow up of study patients so that inguinal relapse if any occur will be salvaged successfully. If this treatment approach is successful, it could be practice changing with improvement of H-QOL of patient.

Being tested
chemo-radiation treatment
Keywords
radiotherapy
Medical subject headings
Anal Canal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chemo-radiation treatmentRadiation

    Radiotherapy (RT) with concurrent 5-fluorouracil and mitomycin-C (5FU/MMC) combination is the treatment of choice for non-metastatic locally advanced anal squam

Study groups in NCT05040815
Study groupRoleWhat they receive
chemo-radiation treatmentExperimentalRadiotherapy 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.
Receives: Radiation: chemo-radiation treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of inguinal lymph node recurrence

    The primary end point is measured by PET/CT imaging at 3 months post treatment and, then CT scan of chest, abdomen and pelvis every 3 months for 2 years and then every 6 months for another year.

    Measured: Total duration of follow up is 36 months

  2. Disease free survival (DFS)

    Time between enrollment and date of relapse (radiographic or clinical progression) leading to change in therapy for recurrent disease or death due to any cause.

    Measured: 36 months

Secondary outcomes (9)

  1. Health related Quality of Life (EORTC QLQ-C30)

    Evaluation will be done using EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30). Assessed at baseline (before starting CRT) and, at 3 months, 12 months, 24 months and 36 months after completion of treatment.

    Measured: 36 months

  2. Health related Quality of Life (EORTC QLQ-AN27)

    Evaluation will be done using EORTC QLQ-AN27, the supplementary module specific for anal cancer. Assessed at baseline (before starting CRT) and, at 3 months, 12 months, 24 months and 36 months after completion of treatment.

    Measured: 36 months

  3. Health related Quality of Life (IIEF)

    Evaluation will be done using International Index of Erectile Function (IIEF) for Men. Assessed at baseline (before starting CRT) and, at 3 months, 12 months, 24 months and 36 months after completion of treatment.

    Measured: 36 months

  4. Health related Quality of Life (FSFI)

    Evaluation will be done using Female Sexual Function Index (FSFI). Assessed at baseline (before starting CRT) and, at 3 months, 12 months, 24 months and 36 months after completion of treatment.

    Measured: 36 months

  5. Health related Quality of Life (Vaizey Score)

    Evaluation will be done using Vaizey Score to analyse severity of anal incontinence. Assessed at baseline (before starting CRT) and, at 3 months, 12 months, 24 months and 36 months after completion of treatment.

    Measured: 36 months

  6. Health related Quality of Life (Fecal Incontinence Severity Index)

    Evaluation will be done using Fecal Incontinence Severity Index. Assessed at baseline (before starting CRT) and, at 3 months, 12 months, 24 months and 36 months after completion of treatment.

    Measured: 36 months

  7. Treatment-related acute toxicities

    Treatment-related acute toxicity will be assessed based on the acute morbidity criteria by NCI CTCAE v.5.0. Acute treatment related morbidity will be assessed weekly during treatment. Then 3 months after completion of treatment.

    Measured: Up to 3 months

  8. Treatment-related late toxicities.

    Late morbidity is defined as morbidity occurring 90 days after completion of treatment. Treatment-related late toxicities will be assessed every 3 months for 2 years and every 6 months for another year.

    Measured: 36 months

  9. Exercise Behavior and Physical Fitness

    Self-reported exercise behavior will be measured before treatment, after treatment, and at 4 months, 8 months, 1-year, 2-year, and 3-year follow-up using the Godin Leisure-Time Exercise Questionnaire [36]. Objective physical fitness will be measured before treatment, after treatment, and at 4 months and 1-year follow-up using the Senior's Fitness Test (SFT) [37, 38]. The SFT consists of: (a) 30-second chair stand, (b) 30-second arm curl, (c) chair sit-and-reach, (d) back scratch, (e) 8-foot up-and-go, and (f) 6-minute walk. These tests, respectively, assess lower and upper body strength, lower and upper body flexibility, agility/dynamic balance, and aerobic endurance.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2021
  2. Study start11 May 2023
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05040815
Sponsor's protocol ID
IIT-0021
Acronym
INSPIRE
Status last verified
Oct 2026
First submitted
29 Jun 2021
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing chemo-radiation treatment in people with Anal Canal Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kurian Joseph, MD (780-432-8755, kurian.joseph@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of inguinal lymph node recurrence (time frame: Total duration of follow up is 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05040815.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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