Gastric Cancer Stage IV, Peritoneal Metastasis
Conditions
Keywords
Gastric cancer, Peritoneal Metastasis
Brief summary
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. * For Arm 1, participants will go for conversion surgery then continue systemic therapy. * For Arm 2, participants will continue systemic therapy. Radiological assessment will be performed every 6 months or upon progression of disease, whichever comes earlier.
Interventions
PROCEDUREConversion Surgery
Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy
systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy
Sponsors
Karolinska University Hospital
University of Lyon
M.D. Anderson Cancer Center
Seoul National University Hospital
University of Oxford
Peter MacCallum Cancer Centre, Australia
Queen Mary Hospital, Hong Kong
Chinese University of Hong Kong
University Hospital, Lille
Erasmus Medical Center
University Hospital, Montpellier
Universita di Verona
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* GCPM detected on surgical exploration and demonstrated by histology or cytology * Primary GC not resected * Age \> 21 (or \> 18 as allowed by individual institution review boards)
Exclusion criteria
* Pregnant and lactating females * Prior surgical treatment for GC involving resection * Clinical or radiological progression during 1st line systemic treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From enrollment to the end of follow-up at 36 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | From enrollment to the end of follow-up at 36 months. | 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. |
| Quality of Life - General Health Status (EQ-5D-5L) | Baseline and scheduled follow-up visits up to 36 months. | 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). |
| Surgical outcomes | From surgery to 90 days post-operation, and up to the end of follow-up at 36 months for late events. | Incidence of postoperative complications graded according to the Clavien-Dindo classification. |
| Quality of Life - Global Health Status (EORTC QLQ-C30 | Baseline and scheduled follow-up visits up to 36 months. | 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. |
| Quality of Life - Gastro-Oesophageal Symptoms (EORTC QLQ-OG25) | Baseline and scheduled follow-up visits up to 36 months. | 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. |
Contacts
Primary ContactProfessor Jimmy So
Outcome results
None listed