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

NCT ID: NCT02995850

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2022-05-05

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

Detailed Description

Peritoneal metastases in gastric cancer are considered to indicate terminal disease due to poor prognosis because systemic chemotherapy is unlikely to accumulate in peritoneal nodules in cytotoxic concentrations. Cytoreductive surgery (CRS) along with hyperthermic intraperitoneal chemotherapy (HIPEC) has been suggested to improve survival in select patients with limited peritoneal spread, resulting in a median overall survival (OS) of 8 to 14 months. It remains unclear, however, which regimen is best and who have benefits from CRS and HIPEC. Herein, we has conducting prospective phase Ib/II trial of CRC and HIPEC with intraperitoneal paclitaxel and cisplatin, and oral S-1 in gastric cancer with peritoneal metastasis.

Conditions

Gastric Cancer With Peritoneal Metastasis (PCI<12)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

anti-cancer drug

Group Type: EXPERIMENTAL

CRS+HIPEC

Intervention Type: 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.

Interventions

CRS+HIPEC

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient age of 19 years or older and age of 75 years or younger.

2. Histologically proven gastric or esophagogastric junction adenocarcinoma with peritoneal metastasis under diagnostic laparoscopy.

3. Primary tumor measured as resectable in preoperative images.

4. Performance status based on ECOG : 0~1

5. No prior treatment (chemotherapy, radiotherapy, etc.)

6. 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

7. Patients who can understand this study and sign the consent form.

Exclusion Criteria

1. 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.)

2. 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)

3. HER2 positive patient

4. Patient with active viral infection (for example, HIV, HBV, HCV, except stable status of HBV infection)

5. 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

7. 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
• Recent active gastric infection

8. Patient with another primary cancer within last 5 years

9. Patient on medication which can interact with the drugs used in this study (fluoropyrimidine-group antineoplastic agents, flucytosine, phenytoin, etc)

10. Patients with other systemic chemotherapy or radiotherapy

11. Patients with psychiatric or neurologic disorder so that he or she cannot understand and sign the consent form.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Surgery, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2016-0252

Identifier Type: -

Identifier Source: org_study_id