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

Who is this study for? Patients with Anal Canal Cancer
What treatments are being studied? Chemo-Radiation Treatment
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Canada
Cross Cancer Institute
RECRUITING
Edmonton
Contact Information
Primary
Kurian Joseph, MD
kurian.joseph@ahs.ca
780-432-8755
Time Frame
Start Date: 2023-05-11
Estimated Completion Date: 2028-05
Participants
Target number of participants: 45
Treatments
Experimental: chemo-radiation treatment
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.
Related Therapeutic Areas
Sponsors
Leads: AHS Cancer Control Alberta

This content was sourced from clinicaltrials.gov

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