BridgeMD
New treatment option for Gastric Cancer
Official title Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
ClinicalTrials.gov ID: NCT04597294
What this study is testing
What is FLOT + HIPEC + Surgery?
FLOT + HIPEC + Surgery is an investigational medicine, being studied as a potential treatment for gastric cancer.
Also referred to as Prophylactic HIPEC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study was designed to evaluate the efficacy of perioperative FLOT chemotherapy in combination with perioperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced gastric cancer at high risk of peritoneal metastases. The impact of treatment on peritoneal recurrence and survival over 6 months, 1, 3 and 5 years will be assessed.
- Phase 3: a large, late-stage study
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Gastric cancer confirmed histopathologically in tumor specimens.
- Age 18-75 years.
- Advanced gastric cancer cT3 / cT4a / N0-3b.
- No distant metastases on computed tomography (CT) scan of the chest, abdomen and pelvis (cM0).
- Written consent to participate in the study.
You likely can't join if
- No clear histopathological confirmation of gastric cancer.
- Age \> 75 years.
- Poor general condition (Performance Status 3 or more on the Eastern Cooperative Oncology Group (ECOG)/World Health Organization scale).
- Previous abdominal surgery (including oncological surgery), other than laparoscopic cholecystectomy or appendectomy (open or laparoscopic).
- Pregnancy and lactation.
- Refusal to participate or an inability to provide written consent.
See the full eligibility criteria
- Gastric cancer confirmed histopathologically in tumor specimens.
- Age 18-75 years.
- Advanced gastric cancer cT3 / cT4a / N0-3b.
- No distant metastases on computed tomography (CT) scan of the chest, abdomen and pelvis (cM0).
- Written consent to participate in the study.
- No clear histopathological confirmation of gastric cancer.
- Age \> 75 years.
- Poor general condition (Performance Status 3 or more on the Eastern Cooperative Oncology Group (ECOG)/World Health Organization scale).
- Previous abdominal surgery (including oncological surgery), other than laparoscopic cholecystectomy or appendectomy (open or laparoscopic).
- Pregnancy and lactation.
- Refusal to participate or an inability to provide written consent.
- Coexisting cancer in another location.
- Systemic treatment or radiotherapy for another cancer.
- Dysphagia requiring surgical treatment (gastric resection or nutritional jejunostomy) before starting neoadjuvant treatment and indication for accelerated surgery for other reasons.
- Disqualification for perioperative FLOT4 chemotherapy as decided by a multi-specialist consultation.
The study team makes the final eligibility decision.
Where it's taking place
- Krakow, Lesser Poland Voivodship, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Krakow, Lesser Poland Voivodship, Poland. 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.