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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 chemotherapy for metastatic disease,
. Previously received cisplatin except for concomitant chemoradiotherapy,
. 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,