Anal cancer Cancer Malignant neoplasm of anus and anal canal
Conditions
Interventions
Current interventions as of 03/04/2023:
ACT3 (recruitment end date: 31/10/2023):
Observation arm
No further treatment after local excision.
Intervention arm
Either a 3D conformal plan or a single p
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: Key inclusion criteria for all three trials include: 1. Provision of written informed consent 2. Histologically-proven, invasive primary squamous, basaloid, or cloacogenic carcinoma of the anus 3. Adequate bone marrow, hepatic and renal function 4. HIV negative or HIV positive and receiving effective antiretroviral therapy and CD4 count >200 5. Aged 16 years or over 6. Fit for all protocol defined treatments 7. Prepared to practice methods of contraception during treatment and until 6 months post end of treatment 8. Able to undergo all mandated staging and follow-up investigations, including MRI Trial-specific inclusion criteria: ACT3 T1 N0 or Nx anal margin tumour treated by local excision; ECOG performance status 0-2 ACT4 T1-2 up to 4cm N0 or Nx anal canal or anal margin tumour; ECOG performance status 0-1 ACT5 T2 N1-3 or T3-4 Nany anal canal or anal margin tumour; ECOG performance status 0-1
Exclusion criteria
Exclusion criteria: Key exclusion criteria for all three trials include: 1. Definite evidence of metastatic disease 2. Prior invasive malignancy unless disease-free for a minimum of 3 years (exluding basal cell carcinoma of the skin or other in situ carcinomas) 3. Prior systemic chemotherapy for anal cancer 4. Prior radiotherapy to the pelvis 5. Uncontrolled cardiorespiratory comorbidity 6. Pregnant or lactating 7. Immunocompromised (organ transplant) Trial-specific exclusion criteria: ACT3 Where a piecemeal local excision precludes assessment of tumour size and margin status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Locoregional failure (failure at the primary site (local) and/or surrounding nodal sites (regional) i.e. any failure within the pelvis up to the level of the sacral promontory) at 3 years post close of recruitment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acute toxicities, assessed according to the current NCI-CTCAE or RTOG (for skin toxicity) criteria, during each week of treatment (with the exception of the ACT3 observation arm) 2. Late toxicities, measured by patient reported outcomes via EORTC QLQ-C30 and CR29 questionnaires at 6 weeks, 6, 12, 24 and 36 months post the end of treatment 3. Treatment compliance, measured on a weekly basis by assessment of total dose of radiotherapy received, duration of treatment, delays to treatment due to toxicity, and any chemotherapy dose modifications 4. Clinical response rate (cRR) (ACT4 and 5), assessed by MRI imaging in accordance with the Tumour Regression Grading System at 3 and 6 months post end of treatment 5. Disease-free survival (DFS), defined as time from randomisation to first documented evidence of pelvic failure. 6. Colostomy-free survival (CFS), measured at baseline, prior to the start of treatment and throughout follow-up and will look at patients who have a pre-treatment colostomy that is still present at 12 months post end of treatment, patients who have a colostomy fitted due to a treatment related toxicity or local disease failure 7. Progression-free survival (PFS), defined as time from randomisation to first documented evidence of disease progression or death from any cause 8. Overall survival (OS), defined as time from randomisation to date of death from any cause 9. Patient Reported Outcome Measures (PROMs), assessed by EORTC QLQ-C30 and CR29 questionnaires at baseline, end of treatment and 6 weeks, 6, 12, 24 and 36 months post the end of treatment Descriptive outcomes: 1. Pattern of pelvic failures i.e. site and position of failure 2. Proportion of participants undergoing salvage surgery (ACT4 and 5) | — |
Countries
England, Ireland, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactSharon Ruddock
Outcome results
None listed