PLATO - Personalising anal cancer radiotherapy dose

Not Applicable

• Conditions: Anal cancer; Cancer; Malignant neoplasm of anus and anal canal

• Registration Number: ISRCTN88455282
• Lead Sponsor: niversity of Leeds

Brief Summary

2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34024700/ investigation of prognostic factors (added 25/05/2021) 2019 Abstract results in https://doi.org/10.1093/annonc/mdz246.013 (added 14/11/2022) Poster results in https://www.postersessiononline.eu/173580348_eu/congresos/ESTRO36/aula/-EP_1277_ESTRO36.pdf (added 14/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-03
• Last Update Posted: 26 September 2023
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 709

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocoregional 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.