NCT07178808 PHASE II EVALUATION OF CYTOREDUCTION SURGERY AND HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (CRS/HIPEC) IN GASTRIC CANCER
| NCT ID | NCT07178808 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Banner Health |
| Condition | Gastric Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-04-16 |
| Primary Completion | 2031-02-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2021-04-16 with a primary completion date of 2031-02-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase II treatment study analyzing the role of preoperative chemotherapy, preoperative laparoscopic HIPEC, and gastrectomy with CRS/HIPEC in gastric adenocarcinoma patients with cytology-positive only carcinomatosis, radiologically-occult carcinomatosis, or radiology apparent peritoneal-surface only metastatic disease.
Eligibility Criteria
Inclusion Criteria: * 1\) Age 18 years and above. There will be no upper age restriction. 2)ECOG performance status ≤ 2. (See Appendix A -ECOG Performance Status Scale). 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 \<= 1.5 mg/dL 5)Distant metastatic disease of peritoneum may be visualized on imaging: <!-- --> 1. Positive peritoneal cytology only 2. Carcinomatosis on diagnostic laparoscopy or laparotomy. Exclusion Criteria: * 1)Distant metastatic disease not limited to peritoneum: 1. Solid organ metastases (liver, central nervous system, 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 ofchildbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) 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. 4)Participants with unstable angina or New York Heart Association Grade II or greater congestive heart failure. 5\) Participants deemed unable to comply with study and/or follow-up procedures. 6)Participants 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.
Frequently Asked Questions
Who can join the NCT07178808 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07178808 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07178808 currently recruiting?
Yes, NCT07178808 is actively recruiting participants. Visit ClinicalTrials.gov or contact Banner Health to inquire about joining.
Where is the NCT07178808 trial being conducted?
This trial is being conducted at Gilbert, United States.
Who is sponsoring the NCT07178808 clinical trial?
NCT07178808 is sponsored by Banner Health. The trial plans to enroll 30 participants.