Trial Outcomes & Findings for Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer (NCT NCT02891447)

NCT ID: NCT02891447

Last Updated: 2024-09-19

Results Overview

Overall survival from the date of diagnosis in subjects with stage IV gastric cancer

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: Date of diagnosis to date of death or last follow-up
• Results posted on: 2024-09-19

Participant Flow

Phase II single arm trial at a single clinic and hospital from September 2016 to March 2019.

Exclusion criteria included stage IV disease outside of the peritoneum

Participant milestones

Measure	Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy cytoreduciton, gastrectomy, and intraperitoneal chemotherapy
Overall Study STARTED	20
Overall Study Subtotal Gastrectomy	11
Overall Study Total Gastrectomy	9
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer

Baseline characteristics by cohort

Measure	Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy n=20 Participants cytoreduciton, gastrectomy, and intraperitoneal chemotherapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	58 Years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Date of diagnosis to date of death or last follow-up

Overall survival from the date of diagnosis in subjects with stage IV gastric cancer

Outcome measures

Measure	Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy n=20 Participants cytoreduciton, gastrectomy, and intraperitoneal chemotherapy
Overall Survival	22.1 Months Interval 15.4 to 30.3

SECONDARY outcome

Timeframe: 90-days from surgery

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

Outcome measures

Measure	Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy n=20 Participants cytoreduciton, gastrectomy, and intraperitoneal chemotherapy
Clavien-Dindo Surgical Complications Grade III	6 events
Clavien-Dindo Surgical Complications Grade I and II	15 events
Clavien-Dindo Surgical Complications Grade IV	1 events

Adverse Events

Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy

Serious events: 7 serious events

Other events: 15 other events

Deaths: 14 deaths

Serious adverse events

Measure	Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy n=20 participants at risk Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy
General disorders Grade III	30.0% 6/20 • 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
General disorders Grade IV	5.0% 1/20 • 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

Other adverse events

Measure	Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy n=20 participants at risk Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy
General disorders Grade I	5.0% 1/20 • 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
General disorders Grade II	70.0% 14/20 • 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

Additional Information

Dr. Brian Badgwell

University of M D Anderson Cancer Center

Phone: 713-745-7351

Email: bbadgwell@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place