Status:
UNKNOWN
A Phase II Study of Conversion Surgery After IP Paclitaxel With XELOX Chemotherapy in AGC With Peritoneal Dissemination
Lead Sponsor:
Gangnam Severance Hospital
Conditions:
Advanced Gastric Cancer
Peritoneal Carcinomatosis
Eligibility:
All Genders
19-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04797923
Start Date
December 1 2019
End Date
December 30 2021
Last Update
March 15 2021
Active Locations (1)
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1
Gangnam Severacne Hospital
Seoul, Gangnnam, South Korea