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

NCT04797923 | Unknown Phase 2

• 1 other identifier: 3-2020-0237
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Gastric Cancer; Peritoneal Carcinomatosis

Keywords

Intraperitoneal chemotherapy, Conversion surgery, Advanced gastric cancer, peritoneal carcinomatosis

Outcome Measures

Primary Outcomes (1)

• Rate of R0 resection

  Success rate of conversion surgery (Rate of R0 resection)

  30 days after the surgery

Study Arms (1)

Intraperitoneal paclitaxel with systemic chemotherapy

EXPERIMENTAL

Drug: 1. Treatment: IP chemotherapy + Systemic chemotherapy; Procedure: 2. Response evaluation after 4 cycles of IP + systemic chemotherapy

Interventions

1. Treatment: IP chemotherapy + Systemic chemotherapy DRUG

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

Intraperitoneal paclitaxel with systemic chemotherapy

2. Response evaluation after 4 cycles of IP + systemic chemotherapy PROCEDURE

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.

Intraperitoneal paclitaxel with systemic chemotherapy

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severacne Hospital

Seoul, Gangnnam, South Korea

RECRUITING

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Central Study Contacts

Seung Ho Choi, M.D., Ph.D.

CONTACT

82-2-2019-3374; choish@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 15, 2021
• Study Start: December 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 15, 2021

Record last verified: 2021-03

Locations

KR (1)