Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer

NCT05040815 | Recruiting Phase 2 DMC

• 1 other identifier: IIT-0021
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Anal Canal Cancer

Keywords

radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

  Total duration of follow up is 36 months

• 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.

  36 months

Secondary Outcomes (9)

• Health related Quality of Life (EORTC QLQ-C30)

  36 months

• Health related Quality of Life (EORTC QLQ-AN27)

  36 months

• Health related Quality of Life (IIEF)

  36 months

• Health related Quality of Life (FSFI)

  36 months

• Health related Quality of Life (Vaizey Score)

  36 months

Other Outcomes (1)

• Relationship between radiotherapy treatment planning variables and acute toxicity.

  36 months

Study Arms (1)

chemo-radiation treatment

EXPERIMENTAL

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.

Radiation: chemo-radiation treatment

Interventions

chemo-radiation treatment RADIATION

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

chemo-radiation treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

MeSH Terms

Conditions

Anal Canal Carcinoma

Study Officials

• Kurian Joseph, MD

  AHS-CCI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kurian Joseph, MD

CONTACT

780-432-8755; kurian.joseph@ahs.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: September 10, 2021
• Study Start: May 11, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-10

Locations

CA (1)