RECRUITING

Study of Sequential Systemic Therapy + Intraperitoneal Paclitaxel in Gastric/GEJ Peritoneal Carcinomatosis

Conditions

Gastric Cancer Peritoneal Carcinomatosis Gastroesophageal Junction Adenocarcinoma Gastroesophageal Junction (GEJ) Adenocarinoma Paclitaxel 5-FU Fluorouracil Leucovorin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase II clinical trial assessing the safety and efficacy of sequential systemic and intraperitoneal (IP) chemotherapy in patients with primary gastric/gastroesophageal junction cancer with cytology positive peritoneal lavage and/or peritoneal carcinomatosis.

Official Title

Phase II Trial of Sequential Systemic Therapy Plus Intraperitoneal Paclitaxel in Gastric/GEJ Cancer Peritoneal Carcinomatosis (STOPGAP)

Quick Facts

Study Start:2021-02-18

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04762953

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must have histologically or cytologically confirmed primary gastric or gastroesophageal adenocarcinoma and have received a minimum of three months of first line systemic treatment without visceral metastatic progression * Must have peritoneal cytology positive disease or peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy * Age ≥ 18 -75 years * Performance status: ECOG performance status ≤ 2 (Appendix A) . ECOG 2 allowed is attributed to malignancy (rather than comorbidities) * Life expectancy of greater than 6 months * Adequate organ and marrow function as defined below: 1. Leukocytes: ≥ 2,000/mcL 2. Absolute Neutrophil Count: ≥ 1,500/mcL 3. Platelets: ≥ 80,000/mcL 4. Total Bilirubin: within normal institutional limits 5. AST(SGOT)/ALT(SPGT): ≤5 X institutional upper limit of normal 6. Creatinine: \< 1.5 X institutional upper limit of normal 7. Hemoglobin: \> 8.0 g/dL (may be transfused) 8. Serum albumin: ≥ g/dL * Ability to understand and the willingness to sign a written informed consent	* Systemic treatment for unresectable or metastatic disease for more than three months prior to enrollment * Any evidence of distant, solid organ metastases (visceral (liver, lung, brain), bone, extra-abdominal) * Any evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy * Any evidence of small or large bowel obstruction with the exception of gastric outlet obstruction due to primary malignancy * Uncontrolled intercurrent illness including, but not limited to, the following conditions: 1. Ongoing or active infection 2. Symptomatic congestive heart failure 3. Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic event,) within 3 months before initiation of treatment 4. Unstable angina pectoris 5. Cardiac arrhythmia * History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ and not treated with systemic therapy. * Inability to comply with study and follow-up procedures as judged by the Investigator * Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Has an active infection requiring systemic therapy. * Prior surgery that would preclude safe diagnostic laparoscopy and port placement * Has a known history of active tuberculosis (TB; Bacillus tuberculosis). * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator

Inclusion Criteria

Exclusion Criteria

* Patients must have histologically or cytologically confirmed primary gastric or gastroesophageal adenocarcinoma and have received a minimum of three months of first line systemic treatment without visceral metastatic progression
* Must have peritoneal cytology positive disease or peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy
* Age ≥ 18 -75 years
* Performance status: ECOG performance status ≤ 2 (Appendix A) . ECOG 2 allowed is attributed to malignancy (rather than comorbidities)
* Life expectancy of greater than 6 months
* Adequate organ and marrow function as defined below:
1. Leukocytes: ≥ 2,000/mcL
2. Absolute Neutrophil Count: ≥ 1,500/mcL
3. Platelets: ≥ 80,000/mcL
4. Total Bilirubin: within normal institutional limits
5. AST(SGOT)/ALT(SPGT): ≤5 X institutional upper limit of normal
6. Creatinine: \< 1.5 X institutional upper limit of normal
7. Hemoglobin: \> 8.0 g/dL (may be transfused)
8. Serum albumin: ≥ g/dL
* Ability to understand and the willingness to sign a written informed consent

* Systemic treatment for unresectable or metastatic disease for more than three months prior to enrollment
* Any evidence of distant, solid organ metastases (visceral (liver, lung, brain), bone, extra-abdominal)
* Any evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy
* Any evidence of small or large bowel obstruction with the exception of gastric outlet obstruction due to primary malignancy
* Uncontrolled intercurrent illness including, but not limited to, the following conditions:
1. Ongoing or active infection
2. Symptomatic congestive heart failure
3. Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic event,) within 3 months before initiation of treatment
4. Unstable angina pectoris
5. Cardiac arrhythmia
* History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ and not treated with systemic therapy.
* Inability to comply with study and follow-up procedures as judged by the Investigator
* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Has an active infection requiring systemic therapy.
* Prior surgery that would preclude safe diagnostic laparoscopy and port placement
* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-7883

ucstudy@uci.edu

University of California, Irvine Medical Center

CONTACT

Principal Investigator

Maheswari Senthil, MD

PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

Maheswari Senthil, MD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-18

Study Completion Date2025-06

Study Record Updates

Study Start Date2021-02-18

Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

Gastric Cancer
Peritoneal Carcinomatosis
Gastroesophageal Junction (GEJ) Adenocarinoma
Paclitaxel
5-FU
Fluorouracil
Leucovorin

Additional Relevant MeSH Terms

Gastric Cancer
Peritoneal Carcinomatosis
Gastroesophageal Junction Adenocarcinoma