Randomized Phase II Study of the Efficacy and Patients Reported Outcome (PRO) of Cell-free and Concentrated Ascites Re-Infusion Therapy (CART) in Ovarian, Tubal, and Peritoneal Cancer Patients with Abdominal Distention from Malignant Ascites (PRO-ceed study)
JGOG9006
Suzuki Nao
St.Marianna University Hospital
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
+81-44-977-8111
nao@marianna-u.ac.jp
Kuji Shiho
St.Marianna University School of Medicine
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
+81-44-977-8111
s.kuji@marianna-u.ac.jp
Recruiting
April. 16, 2024
Sept. 25, 2024
100
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
supportive care
Patients who meet the following inclusion criteria and do not meet any exclusion criteria will be enrolled as eligible.
1) Patients with newly diagnosed or advanced recurrent ovarian cancer who are scheduled to undergo chemotherapy and who are considered to require ascites treatment for malignant ascites
2) Patients with primary or recurrent ovarian cancer histologically diagnosed as ovarian cancer, fallopian tube cancer, or peritoneal cancer.
Newly diagnosed patients for whom no tissue is available can be enrolled if ovarian cancer is clinically suspected, CA125 is over 200 U/mL, and CEA is less than 20 ng/mL
3) Patients expected to have a sufficient volume of ascitic fluid for CART.
4) Patients who plan to undergo chemotherapy within 2 weeks from the two days after the end of ascites treatment
5) Patients with ECOG PS 0-3
6) Clinically without brain or bone metastases
7) Patients expected to survive for 6 months or longer
8) Patients with sufficient primary organ function
9) Patients with total bilirubin 1.2mg/dL or more
10) Patients capable of ascites drainage and CART
11) Patients with written informed consent
12) Patients aged 20 and above
Patients who meet any of the following conditions are not eligible.
1) Patients planning surgery (PDS, exploratory laparotomy, review laparoscopy, etc.) after ascites drainage or CART before starting chemotherapy
2) Patients who underwent ascites drainage within the past two months. (Diagnostic punctures are not to be excluded.)
3) Patients with severe immunodeficiency due to bone marrow transplantation, etc.
4) Patients with severe heart failure, renal failure, liver failure
5) Patients with alcohol intolerance
6) Patients with concurrent multiple cancers
7) Patients with moderate (Child-Pugh classification class B) or severe (class C) liver dysfunction
8) New York Heart Association (NYHA) class III or IV symptomatic congestive heart failure, unstable angina, symptomatic congestive heart failure, myocardial infarction, uncontrolled severe arrhythmia or other clinical Patients with significant heart disease
9) Poorly controlled diabetes mellitus
10) Patients with intestinal obstruction requiring parenteral administration of fluids and nutrients
11) Patients with suspected intestinal perforation or intra-abdominal infection
12) Patients with an active bleeding diathesis. However, treatment with DOAC, low-dose warfarin, etc. is permissible
13) Patients who are expected to have difficulty in completing this study or follow-up, or when the attending physician judges them to be inappropriate
20age old over
No limit
Female
Ovarian, Tubal, and Peritoneal Cancer
Groups are determined by dynamic randomization. Based on the regulatory factors, the subjects were assigned 1:1 to the ascites drainage group and the CART group by the minimization method.
In the ascites drainage group, chemotherapy will be performed within 2 weeks from the two days after the drainage.
In the CART group, chemotherapy will be performed within 2 weeks from the two days after the reinfusion.
Ovarian, Tubal, and Peritoneal Cancer, Ascite
Changes in the Japanese version of the M.D. Anderson Symptom Inventory (MDASI-J) before and after ascites treatment
Secondary endpoints:
1) Transition of MDASI-J before ascites treatment, 1 week after ascites treatment, and during chemotherapy
2) Transition of EORTC-QLQ-C30 (version 3 Japanese version, hereinafter referred to as QLQ-C30) before ascites treatment, 1 week after ascites treatment, and during chemotherapy
3) Transition of PRO CTCAE (abdominal fullness) before ascites treatment, 1 week after ascites treatment, and during chemotherapy
4) Transition of EQ-5D-5L before and after ascites treatment and one week after ascites treatment
5) Adverse events (Common Terminology Criteria for Adverse Events ver.5.0: CTCAE)
6) Transition of laboratory test values before and after ascites treatment, 1 week after ascites treatment, and during chemotherapy
7) Rate of repeated ascites drainage
8) Ascites drainage volume by ascites treatment
9) Incidence of dose reduction, postponement, or discontinuation of chemotherapy
Exploratory endpoints:
1) Reason for setting the ascites drainage volume
2) Relationship between ascites drainage volume and primary/secondary endpoints
3) Number of cells in ascites drainage and filtered concentrated ascites, the relationship between ascites biochemical data and blood biochemical data
ASAHI KASEI MEDICAL CO., LTD.
SHOWA Medical University Clinical Research Review Board
1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8666 Japan, Tokyo
