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| ID | Type | Description | Link |
|---|---|---|---|
| 26306419.8.0000.0065 | Registry Identifier | Plataforma Brasil - CAAE | |
| 2020/13249-0 | Other Grant/Funding Number | The Sao Paulo Research Foundation, FAPESP |
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Peritoneal carcinomatosis (PC) in gastric cancer (GC) is considered a fatal disease, without expectation of definitive cure. Since conventional surgery is not indicated in the palliative setting, and systemic chemotherapy treatments are not sufficient to contain the disease, a multimodal approach associating intraperitoneal (IP) chemotherapy (CMT) with surgery may represent an alternative for these patients.
IP CMT has shown superior results to conventional treatment in patients at this stage of the disease, and can achieve complete regression of lesions in a significant portion of cases. Once response to treatment is achieved, patients become fit for curative surgery, which offers a new perspective on the survival in these previously unresectable cases, and raising survival rates to similar levels to patients undergoing surgery with curative intention.
Thus, the aim of this study is to evaluate the complete response rate and curative resection in patients with PC by GC at Instituto do Cancer do Estado de São Paulo (ICESP) treated with IP CMT. Patients prospectively included in the study will undergo implantation of a peritoneum catheter to perform outpatient IP CMT in order to promote the regression of lesions. Those with complete regression may be referred for surgical treatment, curing a portion of these patients. The diagnosis of PC will be performed by conventional cytological, immunohistochemical and liquid cytology methods to determine the presence of tumor cells in the peritoneal lavage and to evaluate the sensitivity of the methods. In addition, it is proposed in the study the storage of material for further study of circulating markers in peripheral blood and peritoneal lavage that may be related to response or resistance to treatment.
It is believed that IP CMT may not only increase the survival of patients with PC, but also offer the possibility of cure for a significant portion of patients who are currently without treatment prospects and with a median survival of only six months.
This is a prospective study lasting 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraperitoneal chemotherapy | Experimental | Intraperitoneal chemotherapy in gastric cancer patients with peritoneal carcinomatosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraperitoneal chemotherapy | Combination Product | Patients will undergo intraperitoneal chemotherapy with Paclitaxel (4 cycles) associated with systemic chemotherapy. After treatment, patients will be reassessed and if there is a peritoneal response, they will undergo gastrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete peritoneal response after 04 cycles of intraperitoneal (IP) chemotherapy (CMT) associated with systemic CMT with XP. | Absence of visible carcinomatosis on imaging tests, absence of viable peritoneal lesion at laparoscopy and absence of neoplastic cells in peritoneal lavage. | At the end of Cycle 4 (each cycle is 8 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Time between conversion surgery and date of disease progression, assessed in the first 6 months | 6 months |
| Overall survival (OS) | Time between conversion surgery and last follow-up after 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andre Roncon Dias, MD, PhD | Contact | +55 11 3893-2000 | andre.dias@hc.fm.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Andre Roncon Dias, MD, PhD | Instituto do Câncer de São Paulo - ICESP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Câncer de São Paulo - ICESP | Recruiting | São Paulo | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D010534 | Peritoneal Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| D004358 | Drug Therapy |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D006979 | Hyperthermia, Induced |
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Patients will undergo intraperitoneal chemotherapy with Paclitaxel (4 cycles) associated with systemic chemotherapy. After treatment, patients will be reassessed and if there is a peritoneal response, they will undergo gastrectomy.
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|
|
| 5 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D000008 | Abdominal Neoplasms |
| D010532 | Peritoneal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D043823 |
| Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |