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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| University of Lyon | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| Seoul National University Hospital |
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The goal of this clinical trial is to evaluate the impact of conversion surgery on overall survival (OS) in patients with gastric cancer peritoneal metastases (GCPM) who show a good response to preoperative systemic therapy (including first-line chemotherapy with or without targeted therapy and/or immunotherapy) with or without peritoneal-directed chemotherapy.]. The main question it aims to answer is:
(i) Will Conversion surgery be associated with improved overall survival (OS) in patients with GCPM who respond well to preoperative systemic therapy, compared to patients who do not undergo surgery? (ii) Will Quality of life be comparable or improved in patients who undergo conversion surgery compared to patients receiving palliative chemotherapy as measured by the QLQ-C30 questionnaire?
If there is a comparison group: Researchers will compare Arm 1 (Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy) to Arm 2 (systemic therapy alone (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy) to see if the conversion surgery will be associated with improved overall survival (OS) in Arm 1.
Participants will be randomized to either Arm 1 or Arm 2.
Radiological assessment will be performed every 6 months or upon progression of disease, whichever comes earlier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunot | Experimental |
| |
| systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal d | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conversion Surgery | Procedure | Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time from randomization to death from any cause. Patients alive or lost to follow-up at analysis will be censored at the date last known alive. | From enrollment to the end of follow-up at 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Time from randomization to radiological or clinical recurrence (Arm 1) or progression (Arm 2), or death from any cause, whichever occurs first. Patients alive and without recurrence/progression will be censored at the date last known disease-free. | From enrollment to the end of follow-up at 36 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | Singapore |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D061887 | Conversion to Open Surgery |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019984 | Quality Indicators, Health Care |
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| OTHER |
| University of Oxford | OTHER |
| Peter MacCallum Cancer Centre, Australia | OTHER |
| Queen Mary Hospital, Hong Kong | OTHER |
| Chinese University of Hong Kong | OTHER |
| University Hospital, Lille | OTHER |
| Erasmus Medical Center | OTHER |
| University Hospital, Montpellier | OTHER |
| Universita di Verona | OTHER |
| Antoni van Leeuwenhoek Hospital | OTHER |
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| Systemic Therapy/Standard of Care | Drug | systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy |
|
| Surgical outcomes |
Incidence of postoperative complications graded according to the Clavien-Dindo classification. |
| From surgery to 90 days post-operation, and up to the end of follow-up at 36 months for late events. |
| Quality of Life - Global Health Status (EORTC QLQ-C30 | Change in global health status/quality-of-life score using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scale 0-100; higher scores indicate better global health/QoL. | Baseline and scheduled follow-up visits up to 36 months. |
| Quality of Life - Gastro-Oesophageal Symptoms (EORTC QLQ-OG25) | Change in symptom-specific scores using the EORTC QLQ-OG25 module assessing upper GI symptoms and treatment-related side effects. Scale 0-100; higher scores indicate worse symptoms. | Baseline and scheduled follow-up visits up to 36 months. |
| Quality of Life - General Health Status (EQ-5D-5L) | Change in EQ-5D-5L health status index (range -0.594 to 1.0; higher indicates better health) and visual analog scale (VAS 0-100; higher indicates better perceived health). | Baseline and scheduled follow-up visits up to 36 months. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |