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De klinische studie NCT05040815 (INSPIRE) voor Anuskanaalkanker is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer (INSPIRE) Fase 2 45

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De klinische studie NCT05040815 (INSPIRE) onderzoekt behandeling bij Anuskanaalkanker. Deze Fase 2 interventioneel-studie heeft de status rekruterend. Het doel is om 45 deelnemers te includeren vanaf 11 mei 2023. De studie wordt geleid door AHS Cancer Control Alberta en de voltooiing is gepland op 1 mei 2028. Laatste update op ClinicalTrials.gov: 2 oktober 2025.
Beknopte samenvatting
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

Uitgebreide beschrijving
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...Toon meer
Officiële titel

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

Aandoeningen
Anuskanaalkanker
Andere studie-ID's
  • INSPIRE
  • IIT-0021
NCT-ID
NCT05040815
Startdatum (Werkelijk)
2023-05-11
Laatste update geplaatst
2025-10-02
Verwachte einddatum
2028-05
Inschrijving (Geschat)
45
Studietype
Interventioneel
FASE
Fase 2
Status
Rekruterend
Trefwoorden
radiotherapy
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
Experimenteelchemo-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 ir...Toon meer
chemo-radiation treatment
Radiotherapy (RT) with concurrent 5-fluorouracil and mitomycin-C (5FU/MMC) combination is the treatment of choice for non-metastatic locally advanced anal squam
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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.
36 months
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.
36 months
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.
36 months
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.
36 months
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.
36 months
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.
36 months
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.
Up to 3 months
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.
36 months
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.
36 months
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  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.

  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.
AHS Cancer Control Alberta logoAHS Cancer Control Alberta
Centraal Contactpersoon
Contact: Kurian Joseph, MD, 780-432-8755, [email protected]
1 Studielocaties in 1 landen

Alberta

Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada
Kurian Joseph, MD, Contact
Rekruterend