Radiotherapy without groin treatment for early stage anal cancer

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

This study is testing if skipping radiation to the groin in early stage anal cancer patients with normal test results can reduce side effects and improve their quality of life.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AHS Cancer Control Alberta (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT05040815 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of omitting preventative radiation to the groin in patients with early stage anal cancer who have normal sentinel node biopsy and PET-CT results. The approach involves administering chemo-radiation treatment while assessing whether avoiding radiation to the groin leads to fewer side effects and improved quality of life. The hypothesis is that patients with early clinical stage node negative anal cancer have a low risk of subclinical inguinal lymph node involvement, which can be accurately determined using PET imaging and sentinel lymph node biopsy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically proven early stage anal squamous cell carcinoma and no inguinal nodal involvement.

Not a fit: Patients with advanced anal cancer or those with inguinal nodal involvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce unnecessary radiation exposure and associated side effects for patients with early stage anal cancer.

How similar studies have performed: While similar approaches have been explored in other cancers, this specific method of sparing groin radiation in anal cancer is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Participants capable of giving informed consent.
2. Patients must be 18 years of age or older.
3. Patient should have histologically proven primary squamous cell carcinoma.
4. Patients must have early AC, Stage T1-3 N0 M0.
5. No inguinal nodal involvement confirmed by PET imaging and SLNB.
6. No history of prior malignancy other than non-melanoma skin cancer or other malignancy with disease free survival ≥ 5 years.
7. Performance status ECOG 0-2 / Zubrod performance status ≥70.
8. Patient should be eligible for concomitant chemotherapy (e.g. adequate hepatic, renal and bone marrow function).
9. 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.
10. 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).
11. Females must not breastfeed during study treatment.
12. Male patients should agree to not donate sperm during study treatment.
13. 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.

Exclusion Criteria:

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

Where this trial is running

Edmonton, Alberta

• Cross Cancer Institute — Edmonton, Alberta, Canada (RECRUITING)

Study contacts

• Principal investigator: Kurian Joseph, MD — AHS-CCI
• Study coordinator: Kurian Joseph, MD

Conditions: Anal Canal Cancer, radiotherapy