Advanced Gastric CancerPhase 2NCT04797923
A Phase II Study of Conversion Surgery After IP Paclitaxel With XELOX Chemotherapy in AGC With Peritoneal Dissemination
A Phase 2 study testing 1. Treatment: IP chemotherapy + Systemic chemotherapy and 2. Response evaluation after 4 cycles of IP + systemic chemotherapy in people with Advanced Gastric Cancer and Peritoneal Carcinomatosis, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Advanced Gastric Cancer, Peritoneal Carcinomatosis
- What is being tested?
- 1. Treatment: IP chemotherapy + Systemic chemotherapy and 2. Response evaluation after 4 cycles of IP + systemic chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2019to 30 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severacne Hospital
Seoul, Gangnnam
Seung Ho Choi, 82-2-2019-3374, choish@yuhs.ac
About this study
Official title: 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.
- Conditions
- Advanced Gastric Cancer, Peritoneal Carcinomatosis
- Being tested
- 1. Treatment: IP chemotherapy + Systemic chemotherapy, 2. Response evaluation after 4 cycles of IP + systemic chemotherapy
- Keywords
- Intraperitoneal chemotherapy, Conversion surgery, Advanced gastric cancer, peritoneal carcinomatosis
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Treatment: IP chemotherapy + Systemic chemotherapyDrug
- 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 chemotherapyProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal paclitaxel with systemic chemotherapy | Experimental | Not described Receives: Drug: 1. Treatment: IP chemotherapy + Systemic chemotherapy; Procedure: 2. Response evaluation after 4 cycles of IP + systemic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of R0 resection
Success rate of conversion surgery (Rate of R0 resection)
Measured: 30 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Dec 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Ho Choi, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797923
- Sponsor's protocol ID
- 3-2020-0237
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04797923
- Acronym / sponsor ID
- 3-2020-0237
- Conditions
- Advanced Gastric Cancer, Peritoneal Carcinomatosis
- Keywords
- Intraperitoneal chemotherapy, Conversion surgery, Advanced gastric cancer, peritoneal carcinomatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal paclitaxel with systemic chemotherapy | Experimental | Drug: 1. Treatment: IP chemotherapy + Systemic chemotherapy, Procedure: 2. Response evaluation after 4 cycles of IP + systemic chemotherapy |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (14 listed)
- 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 +)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. Treatment: IP chemotherapy + Systemic chemotherapy1. 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 | Drug | Intraperitoneal paclitaxel with systemic chemotherapy |
| 2. Response evaluation after 4 cycles of IP + systemic chemotherapy2. 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. | Procedure or surgery | Intraperitoneal paclitaxel with systemic chemotherapy |
Primary outcome
Rate of R0 resection
Time frame: 30 days after the surgery
Success rate of conversion surgery (Rate of R0 resection)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1. Treatment: IP chemotherapy + Systemic chemotherapy and 2. Response evaluation after 4 cycles of IP + systemic chemotherapy in people with Advanced Gastric Cancer and Peritoneal Carcinomatosis, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung Ho Choi, M.D., Ph.D. (82-2-2019-3374, choish@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of R0 resection (time frame: 30 days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021; AzTrials last refreshed its copy on 2 Nov 2026.