New treatment option for Gastric Cancer
Official title Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal Carcinomatosis
ClinicalTrials.gov ID: NCT04547725
What this study is testing
- What it's testing
- Background: Approximately 15% of gastric adenocarcinoma patients presents with peritoneal carcinomatosis (PC) at the first encounter and is regarded as an unresectable and end-stage disease. The recommended treatment with palliative chemotherapy alone yields a poor clinical efficacy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 75
You may be able to join if
- Age 20 to 75 years old.
- Blood tests:
- White blood cells \> 4,000/mm3, neutrophils \> 1,500/mm3, platelets \> 100,000/mm3.
- Serum creatinine \ 60 ml/min.
- Serum bilirubin \< 2 mg/dl.
You likely can't join if
- Prior malignancy within 3 years or with detectable signs of recurrence.
- Newly diagnosed gastric adenocarcinoma having been treated by preoperative systemic or intraperitoneal chemotherapy.
- Presence of comorbidities, including liver cirrhosis (≥ Child B), decompensated heart failure (New York Heart Association [NYHA] Class III or IV...
- ≥ American Society of Anesthesiologists Classification (ASA Class) Class 3.
- Pregnancy or breastfeeding.
- Intolerability of chemotherapeutic agents in this study:
See the full eligibility criteria
- Age 20 to 75 years old.
- Blood tests:
- White blood cells \> 4,000/mm3, neutrophils \> 1,500/mm3, platelets \> 100,000/mm3.
- Serum creatinine \ 60 ml/min.
- Serum bilirubin \< 2 mg/dl.
- Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1.
- Not legal incapacity.
- Newly diagnosed gastric adenocarcinoma, including Siewert III adenocarcinoma of the cardia, with limited peritoneal carcinomatosis (PCI ≤ 10) or positive peritoneal wash cytology (CY1/P0) . [
- Prior malignancy within 3 years or with detectable signs of recurrence.
- Newly diagnosed gastric adenocarcinoma having been treated by preoperative systemic or intraperitoneal chemotherapy.
- Presence of comorbidities, including liver cirrhosis (≥ Child B), decompensated heart failure (New York Heart Association [NYHA] Class III or IV congestive heart failure), poorly-controlled chronic obstructive pulmonary...
- ≥ American Society of Anesthesiologists Classification (ASA Class) Class 3.
- Pregnancy or breastfeeding.
- Intolerability of chemotherapeutic agents in this study:
- N-IPEC paclitaxel (all patients).
- Capecitabine or oxaliplatin (patients who receive CAPOX regimen).
- Cisplatin or 5-fluorouracil (patients who receive P-HDFL regimen).
- Distant metastases (e.g. liver, lung, bone) except for the peritoneum, intra-abdominal lymph node, and ovary.
- Extensive PC (PCI \> 10).
- Siewert I or II adenocarcinoma of the cardia.
- Other patients inappropriate for this study in the opinion of the investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.