A Phase Ib/II Study of Efficacy and Feasibility of Cytoreductive Surgery, Extensive Peritoneal Lavage, Hyperthermicintraperitoneal Chemotherapy and Post-operative Intraperitoneal Chemotherapy Combination in Gastric Cancer With Peritoneal Metastasis

NCT02995850 | Completed Phase 1

• 1 other identifier: 4-2016-0252
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, non-randomized, single-center, phase Ib/II study, evaluating efficacy and feasibility of cytoreductive surgery(CRS), extensive peritoneal lavage, hyperthermic intraperitoneal chemotherapy(HIPEC) and post-operative intraperitoneal chemotherapy combination in gastric cancer with peritoneal metastasis

Conditions

Gastric Cancer With Peritoneal Metastasis (PCI<12)

Outcome Measures

Primary Outcomes (2)

• Ib: Maximum tolerate dose

  Ib: To determine the MTD of orally administered S-1 + intraperitoneal paclitaxel +cisplatin in gastric cancer with peritoneal metastasis.

  3 months

• II: Safety

  II:To assess the safety and tolerability of CRS +HIPEC (Clavien-Dindo classification of surgical complication \& NCI-common terminology criteria for adverse events(CTC-AE) for chemotherapy\]

  3 months

Secondary Outcomes (3)

• OS (overall survival)

  12 months

• PFS (Progression-free survival)

  12 months

• RR (response rate)

  12 months

Study Arms (1)

anti-cancer drug

EXPERIMENTAL

Drug: CRS+HIPEC

Interventions

CRS+HIPEC DRUG

1. Ib * Dose-escalation of intraperitoneal paclitaxel will follow a modified 3 + 3 dose escalation procedure. 2. II ① CRS If PCI \<12, CRS will be performed by gastrectomy with D2-lymphadenectomy and resection of any involved adjacent structures. If PCI≥12, instead of CRS, 3 times of IP paclitaxel +cisplatin and oral S-1 chemotherapy every 3 weeks, and then PCI \<12, CRS will be done. ② Extensiveintraperitoneal lavage Peritoneal lavage after CRS will be done with 10 L before HIPEC. ③ HIPEC Following surgery HIPEC will be performed using CDDP (60 mg/m2) and PTX (P2RD mg/m2). IP chemotherapy will be performed. ④ Post-operative intraperitoneal chemotherapy Postoperative chemotherapy will be done 8 cycles of IP paclitaxel+ cisplatin and oral S-1 after 4 weeks.

anti-cancer drug

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age of 19 years or older and age of 75 years or younger.
• Histologically proven gastric or esophagogastric junction adenocarcinoma with peritoneal metastasis under diagnostic laparoscopy.
• Primary tumor measured as resectable in preoperative images.
• Performance status based on ECOG : 0\~1
• No prior treatment (chemotherapy, radiotherapy, etc.)
• Adequate hepatic, renal, and hematologic function
• ANC≥1,500/uL,
• hemoglobin≥9.0g/dL
• platelet≥100,000/uL
• total Bilirubin: ≤ 1.5 × upper normal limit
• Creatinine\<1.5mg/dL
• AST/ALT, ALP ≤ 2.5 x upper normal limit
• Patients who can understand this study and sign the consent form.

You may not qualify if:

• Patient who has distant metastasis or para-aortic lymph node metastasis or retroperitoneal metastasis except peritoneal metastasis. (But the patient who has ovarian metastasis with resectable status can be enrolled.)
• Primary tumor cannot be resected because of direct invasion to other important organ. (But, if the invaded organ can be resected together, such as spleen, gallbladder, distal pancreas, and liver, the patient can be enrolled)
• HER2 positive patient
• Patient with active viral infection (for example, HIV, HBV, HCV, except stable status of HBV infection)
• Pregnant patient, or patient in breast-feeding, or who is planning pregnancy.
• Patients with a history of severe hypersensitivity to these drugs
• Patients with severe bone marrow depression
• patients who has severe hepatic, renal disorder
• patients who has hereditary problem or galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
• Patients who has important medical problem or infection
• Cerebrovascular accident(CVA) within 1 year
• Heart attack within 6 months, uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure(CHF), severe arrhythmia
• Major operation or injury within 28 days
• Severe and not recovered wound, ulcer, fracture
• Uncontrolled bleeding disease

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Surgery, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 19, 2016
• Study Start: February 22, 2017
• Primary Completion: April 19, 2022
• Study Completion: May 5, 2022
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

KR (1)