Robotic Surgery + HIPEC for Stomach Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Distant metastases, Malignant ascites, Comorbidities, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This phase II clinical trial tests how well robotic cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with gastric cancer that has spread to the tissue that lines the wall of the abdominal cavity (peritoneum). Gastric cancer is the third leading cause of cancer related deaths worldwide and peritoneal metastasis are found in 30% of patients at time of diagnosis. Patients with peritoneal metastasis have poor survival rates. Traditional surgery is done with a large incision and has a high complication rate and longer hospital stays. Robot assisted (robotic) cytoreduction is a surgical option that uses small incisions and there is less risk of complications. HIPEC involves infusing heated chemotherapy into the abdominal cavity during surgery. Robotic cytoreduction together with HIPEC may improve recovery and decrease complications after surgery.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for stomach cancer?
Research shows that the combination of docetaxel and cisplatin is effective in treating advanced gastric cancer, with studies indicating it is active against untreated advanced cases and can be part of a successful regimen for marginally resectable gastric cancer.
12345Is the combination of docetaxel and cisplatin safe for treating stomach cancer?
The combination of docetaxel and cisplatin has been studied for stomach cancer and is generally well-tolerated, but it can cause side effects like low white blood cell counts, hair loss, and nausea. These side effects are common but manageable with medical care.
678910What makes the Robotic Surgery + HIPEC treatment for stomach cancer unique?
This treatment combines robotic surgery, which is minimally invasive, with HIPEC (heated chemotherapy applied directly inside the abdomen) using drugs like cisplatin and docetaxel. This approach is unique because it targets cancer cells in the abdomen more directly and may reduce side effects compared to traditional chemotherapy.
1112131415Eligibility Criteria
Adults aged 18-80 with gastric cancer that has spread only to the lining of their abdomen, responding well to chemotherapy, and in good nutritional health can join. They must have a certain level of blood cells, kidney function, and body weight. People with cancer outside the abdomen or severe reactions to chemo can't participate.Inclusion Criteria
I can take care of myself but might not be able to do heavy physical work.
My cancer is confirmed as gastric adenocarcinoma or GE junction adenocarcinoma.
Absolute neutrophil count >= 1,500 / uL
+6 more
Exclusion Criteria
My cancer has spread to organs like the liver, lungs, or bones.
I've had a severe allergic reaction to chemotherapy before.
Comorbidities that would preclude protocol therapy
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo robotic gastrectomy and hyperthermic intraperitoneal chemotherapy (HIPEC) with docetaxel and cisplatin
1 week
Inpatient hospital stay for surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and disease-free survival
30 days
Regular follow-up visits including CT, MRI, or PET/CT scans
Long-term follow-up
Participants are monitored for long-term outcomes such as overall survival and peritoneal recurrence-free survival
Up to 5 years
Participant Groups
The trial is testing robotic surgery combined with heated chemo delivered directly into the belly (HIPEC) for stomach cancer patients with limited spread. It aims to see if this approach reduces complications compared to traditional open surgery.
1Treatment groups
Experimental Treatment
Group I: Treatment (gastrectomy, HIPEC)Experimental Treatment9 Interventions
Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial.
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
🇺🇸 Approved in United States as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
🇨🇦 Approved in Canada as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
🇯🇵 Approved in Japan as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
[Three cases of gastric cancer treated by S-1 combined with docetaxel in place of cisplatin]. [2018]Although combination of S-1 and cisplatin (CDDP) is a standard therapy for advance or recurrent gastric cancer patients, there are some cases where a CDDP administration is difficult for patients. We here report three such cases of gastric cancer treated by S-1 and docetaxel (DOC) combination therapy. Based on our three cases, we believe that S-1 and DOC combination therapy could be suitable for outpatients showing safety and efficacy.
Biweekly fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: a phase II trial of the Arbeitsgemeinschaft Internistische Onkologie. [2022]The combination of docetaxel (Taxotere), cisplatin, and fluorouracil improved efficacy in gastric cancer, but was associated with substantial toxicity. This study was designed to incorporate docetaxel into a tolerable biweekly (once every 2 weeks) oxaliplatin-based chemotherapy regimen.
A phase II study of docetaxel and cisplatin in patients with gastric cancer recurring after or progressing during 5-FU/platinum treatment. [2018]Docetaxel plus cisplatin (DP) is a combination chemotherapy regimen that is active against untreated advanced gastric cancer. We evaluated the feasibility of DP treatment in patients with recurring or metastatic gastric cancer who had been previously treated with other chemotherapy regimens.
Preoperative systemic and intraperitoneal chemotherapy consisting of S-1, cisplatin and docetaxel in patients with marginally resectable gastric cancer. [2018]S-1, cisplatin, and docetaxel (DCS) constitute an effective regimen for gastric cancer. We conducted a retrospective cohort study of systemic DCS and a prospective phase I trial of intraperitoneal DCS in the preoperative setting for marginally resectable gastric cancer.
A multicentre phase II study of docetaxel plus cisplatin for the treatment of advanced gastric cancer. [2018]The optimum regimen for advanced gastric cancer requires definition. This multicentre phase II study evaluated docetaxel-cisplatin combination in advanced gastric cancer.
Phase II study of sorafenib in combination with docetaxel and cisplatin in the treatment of metastatic or advanced gastric and gastroesophageal junction adenocarcinoma: ECOG 5203. [2022]The combination of sorafenib with chemotherapy is well-tolerated and is associated with encouraging response rates in several malignances. Both docetaxel and cisplatin are active in gastric cancer. A phase II study was conducted to determine the efficacy and toxicity of combined sorafenib, docetaxel, and cisplatin in patients with metastatic or advanced adenocarcinoma of stomach or gastroesophageal junction (GEJ).
Phase 2 study of adjuvant chemotherapy with docetaxel, capecitabine, and cisplatin in patients with curatively resected stage IIIB-IV gastric cancer. [2018]Postoperative chemotherapy with S-1 or capecitabine plus oxaliplatin is a standard treatment for resectable gastric cancer (GC). However, survival outcomes of stage IIIB-IV (M0) GC cases are still poor. We investigated the efficacy and safety of docetaxel, capecitabine, and cisplatin (DXP) in patients with stage IIIB-IV GC.
Docetaxel and cisplatin in patients with advanced or recurrent gastric cancer: a multicenter phase I/II study. [2019]Because docetaxel and cisplatin are both active against gastric cancer and have different mechanisms of action, this combination may provide additive or synergistic effects against gastric cancer. This article presents a phase I study designed to determine the recommended dose of cisplatin combined with a fixed dose of docetaxel, and a subsequent phase II study that evaluated the clinical efficacy and feasibility of this combination regimen.
[An early phase II clinical study of RP56976 (docetaxel) in patients with cancer of the gastrointestinal tract]. [2018]An early phase II clinical study of RP56976 (docetaxel), a new semisynthetic agent, was conducted in patients with apparatus digestorius cancer. Two or more intravenous doses of 60 mg/m2 were administered with dose-free intervals of 3-4 weeks. Of the 44 patients enrolled, 32 patients (15 patients with gastric cancer, 16 patients with colon cancer, and 1 patient with pancreatic cancer) completed the scheduled course of treatment. For antitumor efficacy in the 15 patients with gastric cancer that completed the study, 3 showed a partial response (PR)(20.0%). Of the 16 patients with colon cancer that completed the study, 1 showed a partial response (PR)(6.3%). No efficacy was noted in the patient with pancreatic cancer. All three patients with gastric cancer showing a partial response (PR) to docetaxel had displayed no response to previous chemotherapy. Evaluation was made for the primary gastric lesion and metastatic lesions in cervical lymph nodes and liver. The most frequent adverse reactions included leukopenia (100%) and neutropenia (97.2%) and subjective/objective adverse reactions included alopecia (80.6%), anorexia (72.2%), fatigue (52.8%), fever (47.2%) nausea/vomiting (47.2%), and diarrhea (38.9%). Leukopenia was of Grade III or more in 75.0% of the patients and neutropenia was of Grade III or more in 91.7%. All other adverse reactions were acceptable. The results suggest that docetaxel is an effective anticancer agent for gastric cancer.
Phase I/II study of intraperitoneal docetaxel plus S-1 for the gastric cancer patients with peritoneal carcinomatosis. [2022]We designed a phase I/II trial of intraperitoneal (IP) docetaxel plus S-1 to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate its efficacy and safety in gastric cancer patients with peritoneal carcinomatosis (PC).
Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel to treat synchronous peritoneal carcinomatosis from gastric cancer: Results from a Chinese center. [2022]This work was to evaluate the efficacy and safety of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) with lobaplatin and docetaxel to treat peritoneal carcinomatosis (PC) from gastric cancer (GC).
Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel improves survival for patients with peritoneal carcinomatosis from abdominal and pelvic malignancies. [2022]This work was to evaluate the perioperative safety and efficacy of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) with lobaplatin and docetaxel in patients with peritoneal carcinomatosis (PC) from gastrointestinal and gynecological cancers.
Treatment of PERItoneal disease in Stomach Cancer with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: PERISCOPE I initial results. [2021]The role of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) in gastric cancer is unknown. This non-randomized dose-finding phase I-II study was designed to assess the safety and feasibility of HIPEC, following systemic chemotherapy, in patients with gastric cancer and limited peritoneal dissemination. The maximum tolerated dose of normothermic intraperitoneal docetaxel in combination with a fixed dose of intraperitoneal oxaliplatin was also explored.
Extensive Peritonectomy is an Independent Risk Factor for Cisplatin HIPEC-Induced Acute Kidney Injury. [2023]Cisplatin (CDDP)-containing hyperthermic intraperitoneal chemotherapy (HIPEC) is frequently applied in selected patients with peritoneal malignancies derived from ovarian cancer, gastric cancer, and primary peritoneal mesothelioma. HIPEC with CDDP increases perioperative morbidity, in particular by inducing acute kidney injury (AKI). Factors contributing to occurrence of AKI after intraperitoneal perfusion with CDDP have not been sufficiently evaluated.
Phase II trial of prophylactic hyperthermic intraperitoneal chemotherapy in patients with locally advanced gastric cancer after curative surgery. [2021]HIPEC is an emerging procedure to treat peritoneal metastasis of gastric cancer. Data about HIPEC in locally advanced gastric cancer is scarce. The purpose of this trial is to evaluate the safety and toxicity of prophylactic HIPEC with cisplatin for patients with locally advanced gastric cancer.