A Phase II Study of Conversion Surgery After IP Paclitaxel With XELOX Chemotherapy in AGC With Peritoneal Dissemination
NCT ID: NCT04797923
Last Updated: 2021-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
43 participants
INTERVENTIONAL
2019-12-01
2021-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intraperitoneal paclitaxel with systemic chemotherapy
1. Treatment: IP chemotherapy + Systemic chemotherapy
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
2. Response evaluation after 4 cycles of IP + systemic chemotherapy
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.
Interventions
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1. Treatment: IP chemotherapy + Systemic chemotherapy
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
2. Response evaluation after 4 cycles of IP + systemic chemotherapy
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.
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
75 Years
ALL
No
Sponsors
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Gangnam Severance Hospital
OTHER
Responsible Party
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Seung Ho Choi
Professor
Locations
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Gangnam Severacne Hospital
Seoul, Gangnnam, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3-2020-0237
Identifier Type: -
Identifier Source: org_study_id
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