- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04797923
A Phase II Study of Conversion Surgery After IP Paclitaxel With XELOX Chemotherapy in AGC With Peritoneal Dissemination
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
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Seung Ho Choi, M.D., Ph.D.
- Phone Number: 82-2-2019-3374
- Email: choish@yuhs.ac
Study Locations
-
-
Gangnnam
-
Seoul, Gangnnam, Korea, Republic of
- Recruiting
- Gangnam Severacne Hospital
-
Contact:
- Seung Ho Choi
- Phone Number: 82-2-2019-3374
- Email: choish@yuhs.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intraperitoneal paclitaxel with 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of R0 resection
Time Frame: 30 days after the surgery
|
Success rate of conversion surgery (Rate of R0 resection)
|
30 days after the surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Abdominal Neoplasms
- Stomach Neoplasms
- Carcinoma
- Peritoneal Neoplasms
Other Study ID Numbers
- 3-2020-0237
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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