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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

Primary Purpose

Gastric Cancer With Peritoneal Metastasis (PCI<12)

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CRS+HIPEC

About this trial

This is an interventional prevention trial for Gastric Cancer With Peritoneal Metastasis (PCI<12)

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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 in exclusion criteria of TS-1, cisplatin, paclitaxel
- 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
- Recent active gastric infection
Patient with another primary cancer within last 5 years
Patient on medication which can interact with the drugs used in this study (fluoropyrimidine-group antineoplastic agents, flucytosine, phenytoin, etc)
Patients with other systemic chemotherapy or radiotherapy
Patients with psychiatric or neurologic disorder so that he or she cannot understand and sign the consent form.

Sites / Locations

Department of Surgery, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anti-cancer drug

Arm Description

Outcomes

Primary Outcome Measures

Ib: Maximum tolerate dose

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

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]

Secondary Outcome Measures

OS (overall survival)

the length of time from the patient signing the consent form until the patient is still alive

PFS (Progression-free survival)

the length of time from the patient signing the consent form until the patient shows disease progression

RR (response rate)

the proportion of complete response to partial response These will be estimated by the Kaplan-Meire method.

Full Information

NCT ID

NCT02995850

First Posted

December 14, 2016

Last Updated

August 7, 2023

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02995850

Brief Title

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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

February 22, 2017 (Actual)

Primary Completion Date

April 19, 2022 (Actual)

Study Completion Date

May 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer With Peritoneal Metastasis (PCI<12)

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

anti-cancer drug

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

CRS+HIPEC

Intervention Description

Ib Dose-escalation of intraperitoneal paclitaxel will follow a modified 3 + 3 dose escalation procedure. 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.

Primary Outcome Measure Information:

Title

Ib: Maximum tolerate dose

Description

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

Time Frame

3 months

Title

II: Safety

Description

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]

Time Frame

3 months

Secondary Outcome Measure Information:

Title

OS (overall survival)

Description

the length of time from the patient signing the consent form until the patient is still alive

Time Frame

12 months

Title

PFS (Progression-free survival)

Description

the length of time from the patient signing the consent form until the patient shows disease progression

Time Frame

12 months

Title

RR (response rate)

Description

the proportion of complete response to partial response These will be estimated by the Kaplan-Meire method.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 in exclusion criteria of TS-1, cisplatin, paclitaxel 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 Recent active gastric infection Patient with another primary cancer within last 5 years Patient on medication which can interact with the drugs used in this study (fluoropyrimidine-group antineoplastic agents, flucytosine, phenytoin, etc) Patients with other systemic chemotherapy or radiotherapy Patients with psychiatric or neurologic disorder so that he or she cannot understand and sign the consent form.

Facility Information:

Facility Name

Department of Surgery, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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