RECRUITING

A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

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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

To learn about the effects of paclitaxel and gastrectomy (surgery to remove all or part of the stomach) on improving outcomes in patients with gastric cancer.

Official Title

A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

Quick Facts

Study Start:2023-09-08

Study Completion:2030-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05977998

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18 years and above. There will be no upper age restriction. Because no dosing or adverse event data are currently available on the use of intraperitoneal paclitaxel in patients \<18 years of age, children are excluded from this study. 2. ECOG performance status ≤ 2 (Karnofsky ≥60%). Appendices 1 and 2. 3. Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction. 4. Adequate renal, and bone marrow function: 1. Leukocytes \>= 3,000/uL 2. Absolute neutrophil count \>= 1,500/uL 3. Platelets \>= 60,000/Ul 4. Serum creatinine \<= 1.6 mg/dL 5. Distant Metastatic Disease of peritoneum: 1. Positive peritoneal cytology, or 2. Carcinomatosis on diagnostic laparoscopy or laparotomy. 6. Completion of preoperative systemic cytotoxic chemotherapy. Targeted therapy, such as HER2 directed therapy, and immunotherapy, such as PD-1 inhibitors, may be continued. 7. English and non-English speaking patients are eligible.	1. Distant metastatic disease not limited to the peritoneum such as solid organ metastases to the liver, central nervous system, or lung. 2. Infections such as pneumonia or wound infections that would preclude protocol therapy. 3. Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who are not postmenopausal defined as no menses in greater than or equal to 12 months, have not had a hysterectomy or bilateral salpingo-oophorectomy, do not have ovarian failure, or have not had a surgical sterilization procedure) must agree to refrain from breast-feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence. Men with reproductive potential must agree to an appropriate method of birth control, including abstinence or double barrier method (diaphragm plus condom). 4. Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure. 5. Subjects, such as those with cognitive impairment, deemed unable to comply with study and/or follow-up procedures. 6. Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity. 7. Previous surgery that would preclude safe cytoreduction and intraperitoneal port placement.

Inclusion Criteria

Exclusion Criteria

1. Age 18 years and above. There will be no upper age restriction. Because no dosing or adverse event data are currently available on the use of intraperitoneal paclitaxel in patients \<18 years of age, children are excluded from this study.
2. ECOG performance status ≤ 2 (Karnofsky ≥60%). Appendices 1 and 2.
3. Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
4. Adequate renal, and bone marrow function:
1. Leukocytes \>= 3,000/uL
2. Absolute neutrophil count \>= 1,500/uL
3. Platelets \>= 60,000/Ul
4. Serum creatinine \<= 1.6 mg/dL
5. Distant Metastatic Disease of peritoneum:
1. Positive peritoneal cytology, or
2. Carcinomatosis on diagnostic laparoscopy or laparotomy.
6. Completion of preoperative systemic cytotoxic chemotherapy. Targeted therapy, such as HER2 directed therapy, and immunotherapy, such as PD-1 inhibitors, may be continued.
7. English and non-English speaking patients are eligible.

1. Distant metastatic disease not limited to the peritoneum such as solid organ metastases to the liver, central nervous system, or lung.
2. Infections such as pneumonia or wound infections that would preclude protocol therapy.
3. Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who are not postmenopausal defined as no menses in greater than or equal to 12 months, have not had a hysterectomy or bilateral salpingo-oophorectomy, do not have ovarian failure, or have not had a surgical sterilization procedure) must agree to refrain from breast-feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence. Men with reproductive potential must agree to an appropriate method of birth control, including abstinence or double barrier method (diaphragm plus condom).
4. Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
5. Subjects, such as those with cognitive impairment, deemed unable to comply with study and/or follow-up procedures.
6. Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity.
7. Previous surgery that would preclude safe cytoreduction and intraperitoneal port placement.

Contacts and Locations

Study Contact

Hsiu-Yin Chang, RN

CONTACT

713-745-7335

hchang@mdanderson.org

Principal Investigator

Brian Badgwell, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Brian Badgwell, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson 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 Date2023-09-08

Study Completion Date2030-10-31

Study Record Updates

Study Start Date2023-09-08

Study Completion Date2030-10-31

Terms related to this study

Additional Relevant MeSH Terms

Gastric Adenocarcinoma
Carcinomatosis