PLATO - PersonaLising Anal cancer radioTherapy dOse - Incorporating Anal Cancer Trials (ACT) ACT3, ACT4 and ACT5

niversity of Leeds0 个研究点目标入组 709 人开始时间: 2016年8月3日最近更新: 2023年9月26日

适应症

试验速览

•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:
•T1 N0 or Nx anal margin tumour treated by local excision; ECOG performance status 0-2
•T1-2 up to 4cm N0 or Nx anal canal or anal margin tumour; ECOG performance status 0-1
•T2 N1-3 or T3-4 Nany anal canal or anal margin tumour; ECOG performance status 0-1

•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:
•Where a piecemeal local excision precludes assessment of tumour size and margin status

发起方

niversity of Leeds