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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

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ClinicalTrials.gov Identifier: NCT02995850
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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

Condition or disease Intervention/treatment Phase
Gastric Cancer With Peritoneal Metastasis (PCI<12) Drug: CRS+HIPEC Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: anti-cancer drug Drug: 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.





Primary Outcome Measures :
  1. Ib: Maximum tolerate dose [ Time Frame: 3 months ]
    Ib: To determine the MTD of orally administered S-1 + intraperitoneal paclitaxel +cisplatin in gastric cancer with peritoneal metastasis.

  2. II: Safety [ Time Frame: 3 months ]
    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 :
  1. OS (overall survival) [ Time Frame: 12 months ]
    the length of time from the patient signing the consent form until the patient is still alive

  2. PFS (Progression-free survival) [ Time Frame: 12 months ]
    the length of time from the patient signing the consent form until the patient shows disease progression

  3. RR (response rate) [ Time Frame: 12 months ]
    the proportion of complete response to partial response These will be estimated by the Kaplan-Meire method.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995850


Contacts
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Contact: Woo Jin Hyung, M.D. 82-2-2228-2129 WJHYUNG@yuhs.ac

Locations
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Korea, Republic of
Department of Surgery, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Woo Jin Hyung, MD    82-2-2228-2129    WJHYUNG@yuhs.ac   
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02995850    
Other Study ID Numbers: 4-2016-0252
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Stomach Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases