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A Phase II Study of Conversion Surgery After IP Paclitaxel With XELOX Chemotherapy in AGC With Peritoneal Dissemination

Primary Purpose

Advanced Gastric Cancer, Peritoneal Carcinomatosis

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
1. Treatment: IP chemotherapy + Systemic chemotherapy
2. Response evaluation after 4 cycles of IP + systemic chemotherapy
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring Intraperitoneal chemotherapy, Conversion surgery, Advanced gastric cancer, peritoneal carcinomatosis

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically or cytologically confirmed advanced gastric cancer adenocarcinoma
  2. Peritoneal metastasis histopathologically confirmed by laparoscopy or laparotomy and PCI <12 (including patients with no gross peritoneal lesion and cytology positive)
  3. No prior surgery for curative aim and previous chemotherapy for recurrent/metastatic gastric cancer
  4. Patient who is willing and able to provide written informed consent/assent for the trial
  5. Age between 19 and 75 years
  6. Measurable lesion according to RECIST 1.1 criteria
  7. ECOG performance status 0-1

  8. Have adequate organ function

    • ANC ≥ 2,000/uL,
    • hemoglobin ≥ 9.0g/dL
    • platelet ≥ 100,000/uL
    • total Bilirubin: ≤ 1.5 × upper normal limit
    • Creatinine ≤ 1.5 × upper normal limit or Creatinine clearance ≥ 60ml/min
    • AST/ALT ≤ 3.0 x upper normal limit
    • Albumin ≥ 2.5 g/dL
    • PT or INR, aPTT ≤ 1.5 × upper normal limit
  9. Should agree to use an adequate method of contraception

Exclusion Criteria:

  1. Previous systemic chemotherapy for metastatic/recurrent advanced gastric cancer
  2. 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.)
  3. 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)
  4. BMI ≤ 18.5 kg/m2
  5. HER2 positive patient (IHC 3+, 2+ with in situ hybridization +)
  6. Remnant gastric cancer
  7. Intolerable to oral intake of chemotherapeutic agent or have malabsorption syndrome
  8. Known additional malignancy that is progressing or requires active treatment in recent 3 years (excluding skin basal cell carcinoma, skin squamous cell carcinoma, thyroid cancer, or in situ cervix cancer that has undergone potentially curative therapy)
  9. Symtomatic CNS metastasis and/or leptomeningeal seeding
  10. Autoimmune disease in recent 2 years requiring systemic therapy
  11. Clinically significant heart disease
  12. Peripheral neuropathy ≥ Grade 2
  13. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
  14. History of HIV, HBV, or HCV

Sites / Locations

  • Gangnam Severacne HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraperitoneal paclitaxel with systemic chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Rate of R0 resection
Success rate of conversion surgery (Rate of R0 resection)

Secondary Outcome Measures

Full Information

First Posted
March 11, 2021
Last Updated
March 11, 2021
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04797923
Brief Title
A Phase II Study of Conversion Surgery After IP Paclitaxel With XELOX Chemotherapy in AGC With Peritoneal Dissemination
Official Title
A Phase II Study Evaluating Efficacy and Safety of Conversion Surgery After Intraperitoneal Paclitaxel in Combination With Systemic Capecitabine and Oxaliplatin Chemotherapy in Advanced Gastric Cancer Patients With Peritoneal Dissemination
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Advanced gastric cancer combined with peritoneal seeind has dismal prognosis with poor response to systemic chemotherapy and with rapid aggravation of symptoms such as abdominal pain, ileus, and poor nutritional intake. Intraperitoneal (IP) chemotherapy through IP port or catheter has lower complication than HIPEC (hyperthermic intraperitoneal chemotherapy) and can deliver higher dose of chemotherapy with less systemic toxicity. IP chemotherapy combined with systemic chemotehrapy showed benefit in several clinical trials, despite lack of statistical significance in phase 3 clinical trial. Proper dose/combination of chemotherapeutic agents and indication of IP chemotherapy should be investigated through prospective, large-scale clinical trials. Conversion surgery after cytotoxic chemotherapy showed improved survival in retrospective studies. Our hypothesis is that IP chemotherapy combined with systemic chemotherpay (capecitabine + oxaliplatin) would improve success rate of conversion surgery with R0 resection. In the present study, the treatment regimen consists of intraperitoneal paclitaxel combined with oxaliplatin and capecitabine (XELOX), and will be performed following surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer, Peritoneal Carcinomatosis
Keywords
Intraperitoneal chemotherapy, Conversion surgery, Advanced gastric cancer, peritoneal carcinomatosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraperitoneal paclitaxel with systemic chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
1. Treatment: IP chemotherapy + Systemic chemotherapy
Intervention Description
1. Treatment: IP chemotherapy + Systemic chemotherapy Day1 + Day 8: IP Paclitaxel 40 mg/m2 every 3 weeks Day1: IV Oxaliplatin 100 mg/m2 every 3 weeks Day 1~14: Capecitabine 1000 mg/m2 PO, BID every 3 weeks
Intervention Type
Procedure
Intervention Name(s)
2. Response evaluation after 4 cycles of IP + systemic chemotherapy
Intervention Description
2. Response evaluation after 4 cycles of IP + systemic chemotherapy Conversion surgery will be done following diagnostic laparoscopy after 4 cycles of IP + systemic chemotherapy. Additional 4 cycles of IP + systemic chemotherapy wille be done following surgery. If surgery is impossible after 4th cycle, four additional cycles of treatment will be done, and convertibility will be evaluated. IP chemotherapy should not exceed total of 8 cycles.
Primary Outcome Measure Information:
Title
Rate of R0 resection
Description
Success rate of conversion surgery (Rate of R0 resection)
Time Frame
30 days after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed advanced gastric cancer adenocarcinoma Peritoneal metastasis histopathologically confirmed by laparoscopy or laparotomy and PCI <12 (including patients with no gross peritoneal lesion and cytology positive) No prior surgery for curative aim and previous chemotherapy for recurrent/metastatic gastric cancer Patient who is willing and able to provide written informed consent/assent for the trial Age between 19 and 75 years Measurable lesion according to RECIST 1.1 criteria ECOG performance status 0-1 Have adequate organ function ANC ≥ 2,000/uL, hemoglobin ≥ 9.0g/dL platelet ≥ 100,000/uL total Bilirubin: ≤ 1.5 × upper normal limit Creatinine ≤ 1.5 × upper normal limit or Creatinine clearance ≥ 60ml/min AST/ALT ≤ 3.0 x upper normal limit Albumin ≥ 2.5 g/dL PT or INR, aPTT ≤ 1.5 × upper normal limit Should agree to use an adequate method of contraception Exclusion Criteria: Previous systemic chemotherapy for metastatic/recurrent advanced gastric cancer 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) BMI ≤ 18.5 kg/m2 HER2 positive patient (IHC 3+, 2+ with in situ hybridization +) Remnant gastric cancer Intolerable to oral intake of chemotherapeutic agent or have malabsorption syndrome Known additional malignancy that is progressing or requires active treatment in recent 3 years (excluding skin basal cell carcinoma, skin squamous cell carcinoma, thyroid cancer, or in situ cervix cancer that has undergone potentially curative therapy) Symtomatic CNS metastasis and/or leptomeningeal seeding Autoimmune disease in recent 2 years requiring systemic therapy Clinically significant heart disease Peripheral neuropathy ≥ Grade 2 Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment History of HIV, HBV, or HCV
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung Ho Choi, M.D., Ph.D.
Phone
82-2-2019-3374
Email
choish@yuhs.ac
Facility Information:
Facility Name
Gangnam Severacne Hospital
City
Seoul
State/Province
Gangnnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Ho Choi
Phone
82-2-2019-3374
Email
choish@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

A Phase II Study of Conversion Surgery After IP Paclitaxel With XELOX Chemotherapy in AGC With Peritoneal Dissemination

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