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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02341 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2016-0269 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well heated mitomycin and cisplatin during surgery work in treating patients with stomach or gastroesophageal cancer. Drugs used in chemotherapy, such as mitomycin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To assess overall survival from the date of diagnosis in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis after cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration.
SECONDARY OBJECTIVES:
I. To assess the safety of cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration for subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis.
OUTLINE:
Patients undergo hyperthermic intraperitoneal chemotherapy (HIPEC) comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.
After completion of study treatment, patients are followed up within 4 weeks, and then every 6 months for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (mitomycin, cisplatin) | Experimental | Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Given intraperitoneally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival from the date of diagnosis in subjects with stage IV gastric cancer | Date of diagnosis to date of death or last follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Clavien-Dindo Surgical Complications | 90-day surgical complications graded according to an accepted classification scale (Clavien-Dindo) Classification of Surgical Complications Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V: Death of a patient |
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Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction
Leukocytes >= 3,000/uL
Absolute neutrophil count >= 1,500/uL
Platelets >= 60,000/Ul
Serum creatinine =< 1.5 mg/dL
Distant metastatic disease of peritoneum may be visualized on imaging:
Completion of preoperative systemic chemotherapy and preoperative laparoscopic HIPEC
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian D Badgwell | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32556731 | Derived | Badgwell B, Ikoma N, Murphy MB, Wang X, Estrella J, Roy-Chowdhuri S, Das P, Minsky BD, Lano E, Song S, Mansfield P, Ajani J. A Phase II Trial of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Perfusion with Chemotherapy for Patients with Gastric Cancer and Carcinomatosis or Positive Cytology. Ann Surg Oncol. 2021 Jan;28(1):258-264. doi: 10.1245/s10434-020-08739-5. Epub 2020 Jun 17. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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Exclusion criteria included stage IV disease outside of the peritoneum
Phase II single arm trial at a single clinic and hospital from September 2016 to March 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy | cytoreduciton, gastrectomy, and intraperitoneal chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2018 |
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| Hyperthermic Intraperitoneal Chemotherapy | Drug | Undergo HIPEC |
|
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| Mitomycin | Drug | Given intraperitoneally |
|
|
| 90-days from surgery |
| Subtotal Gastrectomy |
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| Total Gastrectomy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy | cytoreduciton, gastrectomy, and intraperitoneal chemotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival | Overall survival from the date of diagnosis in subjects with stage IV gastric cancer | Posted | Median | 95% Confidence Interval | Months | Date of diagnosis to date of death or last follow-up |
|
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| ||||||||||||||||||||||||||
| Secondary | Clavien-Dindo Surgical Complications | 90-day surgical complications graded according to an accepted classification scale (Clavien-Dindo) Classification of Surgical Complications Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V: Death of a patient | Posted | Number | events | 90-days from surgery |
|
|
Deaths were assessed up to 5 years. Complications according to the grading scale above were assessed 90 days from the date of surgery.
We used the Clavien-Dindo surgical complication grading system, grade III and IV are considered major complications and perhaps similar to serious adverse events, of note, this system does not use the organ system classification of the CTCAE system
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy | Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy | 14 | 20 | 7 | 20 | 15 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade III | General disorders | Clavien-Dindo | Systematic Assessment |
| |
| Grade IV | General disorders | Clavien-Dindo | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade I | General disorders | Clavien-Dindo | Non-systematic Assessment |
| |
| Grade II | General disorders | Clavien-Dindo | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Badgwell | University of M D Anderson Cancer Center | 713-745-7351 | bbadgwell@mdanderson.org |
| May 14, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| C044245 | 1,2-diaminocyclohexaneplatinum II citrate |
| D010984 | Platinum |
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| D016685 | Mitomycin |
| C473651 | Mitozytrex |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
|