A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma (NCT03519295) | Clinical Trial Compass
CompletedPhase 2
A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma
France97 participantsStarted 2018-07-03
Plain-language summary
SCARCE is a non-comparative randomized, 2:1 phase II study. The purpose of this study is to assess the progression-free survival rate at 12 months. (evaluation according with RECISTv1.1 criteria).
For all patients, CT scan will be planned at baseline, and every 8 weeks until 12 months from randomization (or disease progression), and every 12 weeks thereafter.
PET scan will be performed at baseline, at the end of mDCF treatment, and at 12 months after randomization (in absence of disease progression).
CT scan and PET scan will be collected for a centralized review.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, aged ≥18 years,
✓. Performance status Eastern Cooperative Oncology Group World Health Organization (ECOG-WHO) ≤1,
✓. Histologically proven and unresectable locally advanced recurrent or metastatic squamous cell anal carcinoma,
✓. Presence of a target lesion on CT-scan assessed by RECIST v1.1 criteria,
✓. Patient eligible to the mDCF regimen,
✓. CT scan performed within 28 days prior inclusion,
✓. PET scan performed within 28 days prior inclusion,
✓. Signed and dated informed consent,
Exclusion criteria
✕. Previously received chemotherapy for metastatic disease,
✕. Previously received cisplatin except for concomitant chemoradiotherapy,
What they're measuring
1
Progression free survival rate (PFS)
Timeframe: at 12 months
Trial details
NCT IDNCT03519295
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
. Previously received taxanes (paclitaxel or docetaxel) or another spindle poison (navelbine) in the treatment of SCCA,
✕. Previously received anti-tumor immunotherapy (HPV vaccination is allowed),
✕. Previous radiotherapy within 28 days of randomization (14 days if radiotherapy of bone metastases)
✕. Diagnosis of additional malignancy within 3 years prior to the randomization with the exception for curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer,
✕. Any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study,
✕. Current participation in a study of an investigational agent or in the period of exclusion,