A Phase 2 interventional study of Cisplatin and Hyperthermic Intraperitoneal Chemotherapy in Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma and Peritoneal Carcinomatosis, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
366 studies on the registry are indexed under Peritoneal Neoplasms; 56 are open to participants now.
This study's enrollment of 24 is below the median of 45 across 293 interventional studies indexed under Peritoneal Neoplasms.
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Distant metastatic disease of peritoneum may be visualized on imaging:
Exclusion Criteria:
Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.
Drug: Cisplatin · Drug: Hyperthermic Intraperitoneal Chemotherapy · Drug: Mitomycin
Given intraperitoneally
Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
Undergo HIPEC
Also known as: HIPEC
Given intraperitoneally
Also known as: Ametycine, MITO, MITO-C, Mito-Medac, Mitocin, Mitocin-C, Mitolem, Mitomycin C, Mitomycin-C, Mitomycin-X, Mitomycine C, Mitosol, Mitozytrex, Mutamycin, Mutamycine, NCI-C04706
Overall Survival
Overall survival from the date of diagnosis in subjects with stage IV gastric cancer
Time frame: Date of diagnosis to date of death or last follow-up
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
Time frame: 90-days from surgery
Phase II single arm trial at a single clinic and hospital from September 2016 to March 2019.
| Milestone | Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy |
|---|---|
| Started | 20 |
| Subtotal gastrectomy | 11 |
| Total gastrectomy | 9 |
| Completed | 20 |
| Not completed | 0 |
Overall survival from the date of diagnosis in subjects with stage IV gastric cancer
| Months | Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy |
|---|---|
| Overall Survival | 22.1 (15.4 to 30.3) |
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
| events | Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy |
|---|---|
| Grade I and II | 15 |
| Grade III | 6 |
| Grade IV | 1 |
Collected over Deaths were assessed up to 5 years. Complications according to the grading scale above were assessed 90 days from the date of surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy | 14/20 (70%) | 7/20 (35%) | 15/20 (75%) |
| Event | Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy |
|---|---|
| Grade IIIGeneral disorders | 6/20 |
| Grade IVGeneral disorders | 1/20 |
| Event | Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy |
|---|---|
| Grade IIGeneral disorders | 14/20 |
| Grade IGeneral disorders | 1/20 |
| Age, Categorical(Participants) | Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 6 |
| Age, Continuous(Years) | Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy |
|---|---|
| Median | 58 (20 to 75) |
| Sex: Female, Male(Participants) | Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy |
|---|---|
| Female | 7 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 20 |
| Race (NIH/OMB)(Participants) | Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 20 |
| Region of Enrollment(participants) | Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy |
|---|---|
| United States | 20 |
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Studies of the drugs tested here: Cisplatin · Mitomycin