A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanc… (NCT04611724) | Clinical Trial Compass
UnknownPhase 2
A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer
South Korea35 participantsStarted 2020-12-01
Plain-language summary
This study aims to assess objective response rate of modified FOLFIRINOX in advanced urachaus cancer.
Patients with locally advanced, recurrent, or metastatic urachal carcinoma of bladder, urachal will be enrolled this study.
Modified version of FOLFIRINOX(Oxaliplatin 85 mg/m 2, Leucovorin 400mg/m2 , irinotecan 150mg/m2 and 5-FU 2400mg/m2) with prophylactic pegateograstim will be continued till progression, unacceptable toxicity, or till 12 cycles (24 weeks). Study drugs can be administered after 12 cycles to the subjects with benefit from study medication.
Response evaluation will be done every 6 weeks.
Who can participate
Age range19 Years – 65 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed adenocarcinoma of bladder/urachal remnant that is clinically consistent with urachal cancer.
Origin in the anterior wall or dome of the bladder Predominant invasion of muscularis or deeper tissues No obvious origin from the overlying urothelium (relative normal-looking urothelial mucosa) No primary adenocarcinoma elsewhere
* Patients with locally advanced, recurrent, or metastatic disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
* No prior systemic therapy for advanced urachal cancer. For recurrent disease, previous 5-FU, oxaliplatin, or irinotecan chemotherapy as neoadjuvant and/or adjuvant aim is allowed if it ended more than 6 months before enrollment.
* Measurable disease according to RECIST v1.1 criteria
* ECOG performance status 0 or 1
* Age 19 years or older
* Adequate cardiac function
* Adequate bone marrow, hepatic, and renal function Hematology
* Life expectancy more than 3 months
* Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
* Age \> 65
* Previous radiotherapy to the only measurable lesion: but previous radiotherapy will be permitted unless th…