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

March 11, 2021 updated by: Seung Ho Choi, Gangnam Severance Hospital

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

Study Type

Interventional

Enrollment (Anticipated)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

  • 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.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

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.

Clinical Trials on Peritoneal Carcinomatosis

Clinical Trials on 1. Treatment: IP chemotherapy + Systemic chemotherapy

3
Subscribe