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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

NCT02995850

Description:

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

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • 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: 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

Clinical Trial IDs

  • ORG STUDY ID: 4-2016-0252
  • NCT ID: NCT02995850

Conditions

  • Gastric Cancer With Peritoneal Metastasis (PCI<12)

Interventions

DrugSynonymsArms
CRS+HIPECanti-cancer drug

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
anti-cancer drugExperimental
  • CRS+HIPEC

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.

          6. 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

          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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Ib: Maximum tolerate dose
Time Frame:3 months
Safety Issue:
Description:Ib: To determine the MTD of orally administered S-1 + intraperitoneal paclitaxel +cisplatin in gastric cancer with peritoneal metastasis.

Secondary Outcome Measures

Measure:OS (overall survival)
Time Frame:12 months
Safety Issue:
Description:the length of time from the patient signing the consent form until the patient is still alive
Measure:PFS (Progression-free survival)
Time Frame:12 months
Safety Issue:
Description:the length of time from the patient signing the consent form until the patient shows disease progression
Measure:RR (response rate)
Time Frame:12 months
Safety Issue:
Description:the proportion of complete response to partial response These will be estimated by the Kaplan-Meire method.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Yonsei University

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