Cabozantinib in Patients With Advanced Penile Squamous Cell Carcinoma (PSCC) (CaboPen) (CaboPen)
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|ClinicalTrials.gov Identifier: NCT03943602|
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : February 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Penile Squamous Cell Carcinoma||Drug: Cabozantinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cabozantinib in Patients With Advanced Penile Squamous Cell Carcinoma (PSCC): an Open-label, Single-center, Phase 2, Single-arm Trial (CaboPen)|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||September 1, 2022|
Cabozantinib will be administered orally at a dose of 60 mg/day continuously until 28 days prior to planned surgery or at time of the evidence of disease progression or onset of unacceptable toxicity.
Cabozantinib 60 mg/day orally
Other Name: CABOMETYX
- response -rate by RECIST v1.1 criteria [ Time Frame: 40 months ]Assessment of response-rate by RECIST v1.1. Complete response + partial response
- Incidence of treatment-Emergent Adverse Event(safety and tolerability) [ Time Frame: 40 months ]Assessment of the safety and tolerability: incidence, nature and severity of treatment-related adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- Pathologic complete response (pCR) [ Time Frame: 40 months ]Histological report of radical surgery
- Progression-free survival (PFS). [ Time Frame: 40 months ]Recist 1.1 criteria
- Overall Survival (OS). [ Time Frame: 40 months ]time will be calculated as the interval from treatment start date to the date of death for any cause, with censoring at the date of last contact for patients alive.
- Variations of the Quality of Life [ Time Frame: 40 months ]
Variations of the Quality of Life score as assessed with the Edmonton Symptom Assessment Scale (ESAS), validated in Italian language. In this quality of life there are specify 9 main symptons: the score range is from 0 to 10 for each one.
For each symptom the "0 score" corrisponds to "no symptom present" (better outcome) and the "10 score" corrisponds to "maximum symptom assessable" (worse outcome). The listed symptoms are: 1) Pain 2) Fatigue 3) Nausea 4) Depression 5) Anxiety 6) Somnolence 7) Loss of appetite 8) General Malaise 9) Dispnea. The total score is ranging from 0 to 90
- FDG-PET/CT response rate according to EORTC criteria [ Time Frame: 40 months ]
to determine the rate of concordance with CT scan RECIST 1.1 response criteria and PET/CT EORTC Criteria
- Complete response: complete disappearance of all target lesions with the exception of nodal disease (RECIST 1.1) and Complete resolution of FDG uptake in all lesions (EORTC)
- Partial response (PR): greater than or equal to 30% decrease under baseline of the sum of target lesions (RECIST 1.1) and ≥ 25% reduction in the sum of SUVmax
- Stable disease (SD): Not qualify for CR, PR or PD
- Objective Progression (PD): 20% increase in the sum of diameters of target lesions or appearance of new unequivocal malignant lesions (RECIST 1.1) and ≥ 25% Increase in the sum of SUVmax or appearance of new lesions.
- To evaluate the relationship existing between tumor response measured by FDG-PET/CT EORTC Criteria (mainly early PET response as evaluated at first restaging) and pCR-rate (pT0 after surgery) and progression-free survival (months).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943602
|Contact: Daniele Raggi, MDfirstname.lastname@example.org|
|Contact: Michela Rizzuti, Dr.email@example.com|
|Fondazione IRCCS Istituto Nazionale dei Tumori||Recruiting|
|Milano, Italy, 20133|
|Contact: Daniela Raggi, MD +390223902402 firstname.lastname@example.org|
|Study Chair:||Daniele Raggi, MD||Fondazione IRCCS Istituto Nazionale Tumori|