Robotic Surgery + HIPEC for Stomach Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Distant metastases, Malignant ascites, Comorbidities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating stomach cancer that has spread to the abdominal lining. It combines robotic surgery, which uses smaller incisions to reduce complications, with heated chemotherapy (Hyperthermic Intraperitoneal Chemotherapy) applied directly to the abdomen during surgery. The aim is to enhance recovery and minimize post-surgery issues. Individuals diagnosed with stomach cancer that has spread only to the abdomen and who have responded well to chemotherapy may be suitable candidates for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer care.

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 prior data suggests that robotic cytoreduction and HIPEC are safe for treating gastric cancer?

Research has shown that robotic surgery, such as robotic gastrectomy, can be as safe as traditional surgery. In a study with 336 patients, this type of surgery was generally well-tolerated, though it doesn't always reduce post-surgery complications. Robotic surgery uses small incisions, which might lead to fewer complications compared to larger ones.

For hyperthermic intraperitoneal chemotherapy (HIPEC), safety results are mixed. One study found this treatment effective, but its safety can depend on factors like the temperature and duration of the treatment. HIPEC involves warming chemotherapy drugs before placing them in the abdomen, which presents specific risks and benefits.

Both treatments have been studied for safety, but results can vary. Prospective trial participants should discuss with their doctor what these treatments might mean for them personally. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for stomach cancer, which typically involve conventional surgery and chemotherapy, this new approach combines robotic surgery with HIPEC (Hyperthermic Intraperitoneal Chemotherapy). This method allows for precise removal of the tumor using robotic assistance, followed by a direct application of heated chemotherapy drugs, cisplatin and docetaxel, directly into the abdominal cavity. Researchers are excited about this technique because it aims to enhance the precision and effectiveness of tumor removal while potentially increasing the concentration and impact of chemotherapy where it's needed most, possibly leading to better outcomes with fewer side effects.

What evidence suggests that robotic surgery and HIPEC could be effective for stomach cancer?

Research shows that robotic surgery for stomach cancer can lead to better outcomes, including fewer complications and faster recovery compared to traditional surgery. In this trial, participants will undergo robotic gastrectomy combined with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) using docetaxel and cisplatin. Studies suggest that robotic-assisted techniques match the effectiveness of other surgical methods while offering advantages in safety and recovery time. For heated chemotherapy applied directly inside the abdomen (HIPEC), research indicates it can improve survival rates when combined with surgery. Specifically, studies have found that using HIPEC with drugs like cisplatin can help control the spread of cancer within the abdomen. Together, these treatments may offer a promising approach for patients with stomach cancer that has spread to the abdominal lining. ^{1 2 3 4 6}

Who Is on the Research Team?

Travis E Grotz, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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.

Absolute neutrophil count >= 1,500 / uL

Platelets >= 50,000 / Ul

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cisplatin
• Docetaxel
• Gastrectomy
• Hyperthermic Intraperitoneal Chemotherapy
• Robotic Cytoreduction

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (gastrectomy, HIPEC) Experimental Treatment 8 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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The study involving 37 patients with gastric cancer demonstrated that combining cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) is feasible, particularly using 460 mg/m2 of oxaliplatin and a maximum tolerated dose of 50 mg/m2 of normothermic docetaxel.

While serious adverse events occurred in 17 out of 25 patients, the treatment showed manageable safety, with a reoperation rate of 16% and a treatment-related mortality rate of 8%, indicating that this approach can be considered for patients with limited peritoneal dissemination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of PERItoneal disease in Stomach Cancer with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: PERISCOPE I initial results. van der Kaaij, RT., Wassenaar, ECE., Koemans, WJ., et al.[2021]

Prophylactic HIPEC with cisplatin after radical gastrectomy for locally advanced gastric cancer did not increase the incidence of postoperative complications, indicating it is a safe procedure.

While HIPEC did not significantly reduce the risk of peritoneal recurrence compared to standard chemotherapy alone, it did result in a lower percentage of patients with elevated tumor markers, suggesting potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of prophylactic hyperthermic intraperitoneal chemotherapy in patients with locally advanced gastric cancer after curative surgery. Fan, B., Bu, Z., Zhang, J., et al.[2021]

The combination of docetaxel and cisplatin was found to be feasible for treating advanced gastric cancer, with recommended doses established at 60 mg/m² for docetaxel and 80 mg/m² for cisplatin based on a phase I study.

While the overall response rate was modest at 25%, patients with liver metastases showed a higher response rate of 40%, and the median survival time was 9.7 months, suggesting potential for further investigation in this specific patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel and cisplatin in patients with advanced or recurrent gastric cancer: a multicenter phase I/II study. Mitachi, Y., Sakata, Y., Ohtsu, A., et al.[2019]

In a phase II clinical study involving 44 patients with digestive system cancers, docetaxel (RP56976) showed a partial response in 20% of gastric cancer patients, indicating its potential efficacy in this group, especially for those who had not responded to previous treatments.

The treatment was associated with significant adverse effects, including severe leukopenia (100% of patients) and neutropenia (97.2%), but other side effects like alopecia and fatigue were considered acceptable, suggesting that while docetaxel can be effective, careful monitoring of blood cell counts is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An early phase II clinical study of RP56976 (docetaxel) in patients with cancer of the gastrointestinal tract]. Taguchi, T.[2018]

In a phase I/II trial involving 39 gastric cancer patients with peritoneal carcinomatosis, the maximum tolerated dose of intraperitoneal docetaxel was established at 50 mg/m², with a recommended dose of 45 mg/m², showing manageable safety profiles despite some grade 3 toxicities.

The treatment demonstrated promising efficacy, with a 1-year overall survival rate of 70% and an overall response rate of 22%, indicating that intraperitoneal docetaxel combined with S-1 could be a viable option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II study of intraperitoneal docetaxel plus S-1 for the gastric cancer patients with peritoneal carcinomatosis. Fushida, S., Kinoshita, J., Kaji, M., et al.[2022]

The combination of S-1 and docetaxel (DOC) has been successfully used in three cases of gastric cancer where cisplatin (CDDP) treatment was not feasible, suggesting an alternative therapy option.

This combination therapy demonstrated both safety and efficacy, making it a potentially suitable treatment for outpatient gastric cancer patients who cannot tolerate CDDP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Three cases of gastric cancer treated by S-1 combined with docetaxel in place of cisplatin]. Ganno, H., Watayo, Y., Amagasa, H., et al.[2018]

The biweekly FLOT chemotherapy regimen, which includes oxaliplatin, leucovorin, fluorouracil, and docetaxel, showed a 57.7% objective response rate in 54 patients with metastatic gastric cancer, indicating its efficacy.

Despite some significant side effects like neutropenia and leukopenia, the treatment demonstrated a favorable safety profile, with only 3.8% of patients experiencing complicated neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Al-Batran, SE., Hartmann, JT., Hofheinz, R., et al.[2022]

The combination of docetaxel and cisplatin (DP) was found to be effective in treating patients with recurrent or metastatic gastric cancer, achieving an objective response rate of 32.4% among 37 patients, with a median overall survival of 235 days.

The DP regimen was well tolerated, with manageable side effects; however, significant toxicities included neutropenia (51.4%) and leukopenia (27.0%), indicating the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of docetaxel and cisplatin in patients with gastric cancer recurring after or progressing during 5-FU/platinum treatment. Kim, H., Park, JH., Bang, SJ., et al.[2018]

The systemic DCS regimen (S-1, cisplatin, and docetaxel) showed a high response rate of 89% in treating gastric cancer, although 81% of patients experienced grade 3-4 neutropenia, indicating significant but manageable toxicity.

The intraperitoneal DCS regimen demonstrated safety with no dose-limiting toxicity in later patients, and four out of five patients were able to undergo successful R0 resection after treatment, suggesting potential effectiveness for marginally resectable gastric cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative systemic and intraperitoneal chemotherapy consisting of S-1, cisplatin and docetaxel in patients with marginally resectable gastric cancer. Kurokawa, Y., Hamakawa, T., Miyazaki, Y., et al.[2018]

In a phase II study involving 113 patients with advanced gastric cancer, the combination of docetaxel and cisplatin showed an overall response rate of 29.6%, with 5.7% achieving a complete response and 23.9% a partial response.

The treatment demonstrated a manageable safety profile, with 37.5% of patients experiencing severe neutropenia, but only 2% developing febrile neutropenia, indicating that while the treatment is effective, careful monitoring for blood-related side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicentre phase II study of docetaxel plus cisplatin for the treatment of advanced gastric cancer. Fahlke, J., Ridwelski, K., Schmidt, C., et al.[2018]

Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) using lobaplatin and docetaxel is a feasible treatment for peritoneal carcinomatosis (PC), showing acceptable safety with a 30-day serious adverse event rate of 15.2% and a mortality rate of 1.9%.

The treatment resulted in significant tumor marker reductions in 71 out of 82 patients and a median overall survival of 24.2 months, indicating that this approach can effectively prolong survival in selected patients with PC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel improves survival for patients with peritoneal carcinomatosis from abdominal and pelvic malignancies. Wu, HT., Yang, XJ., Huang, CQ., et al.[2022]

In a study of 63 patients undergoing cisplatin (CDDP)-containing hyperthermic intraperitoneal chemotherapy (HIPEC), 66.1% experienced acute kidney injury (AKI), with the extent of parietal peritonectomy being a significant predictor of this complication.

Preclinical rat models showed that bilateral anterior parietal peritonectomy increased systemic absorption of CDDP by 1.6 to 2-fold, suggesting that careful consideration of CDDP dosage and concentration is crucial to minimize systemic toxicity and AKI risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extensive Peritonectomy is an Independent Risk Factor for Cisplatin HIPEC-Induced Acute Kidney Injury. Liesenfeld, LF., Quiring, E., Al-Saeedi, M., et al.[2023]

Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) using lobaplatin and docetaxel showed a median overall survival of 14.3 months in 50 patients with peritoneal carcinomatosis from gastric cancer, with 1-, 2-, and 3-year survival rates of 58%, 40%, and 32%, respectively.

The treatment demonstrated acceptable safety, with no mortality and a 23.1% rate of serious adverse events within 30 days post-surgery, indicating that CRS+HIPEC can be a viable option for improving survival in selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel to treat synchronous peritoneal carcinomatosis from gastric cancer: Results from a Chinese center. Wu, HT., Peng, KW., Ji, ZH., et al.[2022]

In a phase II study involving 44 patients with advanced gastric or gastroesophageal junction adenocarcinoma, the combination of sorafenib, docetaxel, and cisplatin resulted in a partial response rate of 41%, indicating promising efficacy for this treatment regimen.

The median overall survival was 13.6 months, and while the treatment was generally well-tolerated, 64% of patients experienced significant neutropenia, highlighting the need for careful monitoring of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Sun, W., Powell, M., O'Dwyer, PJ., et al.[2022]

In a phase 2 study of 46 patients with stage IIIB-IV gastric cancer, the combination of docetaxel, capecitabine, and cisplatin (DXP) showed promising efficacy, with a median recurrence-free survival of 26.9 months and overall survival of 43.9 months after a median follow-up of 56.1 months.

The treatment was associated with significant toxicities, including neutropenia in 40% of patients, indicating that while DXP is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 study of adjuvant chemotherapy with docetaxel, capecitabine, and cisplatin in patients with curatively resected stage IIIB-IV gastric cancer. Yoon, S., Yoo, C., Ryu, MH., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6668656/

Hyperthermic intraperitoneal chemotherapy with cisplatin ... The 5-year overall survival was 83.3%, although one patient died shortly after 5 years. Baratti [23] published a phase 2 study in 2016 that assessed adjuvant ...

2. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1122755/full

and mitomycin C-based hyperthermic intraperitoneal ... Our results demonstrated that oxaliplatin- and MMC-based HIPEC procedures are both temperature- and duration-dependent in an in vivo tumor model.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798313009438

Hyperthermic intraperitoneal chemotherapy using a ... Here we show the efficacy of the 3-drug combination of mitomycin C (MMC), 5-fluorouracil (5FU), and oxaliplatin (OHP) in an in vitro simulation of HIPEC.

4. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2804110

Efficacy and Safety of Intraoperative Hyperthermic ... This phase 3 randomized clinical trial assesses locoregional control rates after hyperthermic intraperitoneal chemotherapy with mitomycin C

5. jgo.amegroups.org jgo.amegroups.org/article/view/44334/html

Hyperthermic intraperitoneal chemotherapy (HIPEC) for ... ... HIPEC oxaliplatin. Oxaliplatin alone is not an effective chemotherapy agent for colorectal cancer. It has an approximately 20% response rate (23,24). The ...

6. jgo.amegroups.org jgo.amegroups.org/article/view/5503/5760

a review of hyperthermic intraperitoneal chemotherapy and ... Chemotherapy for intraperitoneal use: a review of hyperthermic intraperitoneal chemotherapy and early post-operative intraperitoneal chemotherapy.