NCT00165048

✓ Unanimous Initial: inpatient Requery: mixed — The study requires patients to undergo palliative gastrectomy surgery (inpatient phase) followed by a two-year period of drug intervention and quality of life monitoring (outpatient phase).

✓ Unanimous Initial: outpatient Requery: outpatient — Patients receive oral COX-II inhibitor medication (Vioxx/Rofecoxib) after palliative surgery, which is typically administered on an outpatient basis for chronic management. Thinking: outpatient — The intervention (COX-II inhibitor therapy) is delivered after palliative surgery during a 2-year follow-up period measuring quality of life, indicating patients take the medication at home.

✓ Unanimous Initial: outpatient Requery: inpatient — The intervention is delivered to patients undergoing palliative resection for disseminated stomach cancer, which involves hospitalization for the surgical procedure. Thinking: outpatient — The intervention is long-term oral rofecoxib taken after discharge, delivered in follow-up rather than during a hospital admission.

✓ Unanimous Initial: no

✓ Unanimous Initial: yes Requery: no — This study tests rofecoxib (a COX-II inhibitor drug) as the intervention in patients who have undergone palliative resection, making it a pharmacologic intervention rather than a palliative care service intervention.

✓ Unanimous Initial: no Requery: no — The intervention being tested is a selective COX-II inhibitor drug, not palliative care itself.

✓ Unanimous Initial: yes Requery: yes — The primary outcome explicitly measures 'symptom-free survival,' which constitutes a direct symptom assessment.

✓ Unanimous Initial: no Requery: yes — The primary outcome includes 'Symptom-free survival' which directly measures symptom status in patients. Thinking: yes — Primary outcome includes symptom-free survival, which is a direct symptom assessment.

✓ Unanimous Initial: yes Requery: no — The trial's outcome measures focus on symptom-free survival and overall survival without specifying any direct symptom assessment using validated symptom instruments. Thinking: yes — Primary outcome includes symptom-free survival, which directly measures presence/absence of symptoms.

✓ Unanimous Initial: yes

✓ Unanimous Initial: yes Requery: yes — The study includes overall survival as a secondary outcome, which is not covered by symptom/QoL/dignity/cost categories.

✓ Unanimous Initial: no Requery: yes — The trial includes overall survival as a secondary outcome, which is not related to symptom/QoL/dignity/cost.

✓ Unanimous Initial: other Requery: other — The intervention involves a selective COX-II inhibitor (Rofecoxib), which is a non-steroidal anti-inflammatory drug (NSAID) used for palliative therapy in cancer, fitting into the 'other' category as it does not fall under the specified pharmacologic subgroups.

✓ Unanimous Initial: other Requery: other — Rofecoxib (Vioxx) is a selective COX-II inhibitor being used for palliative therapy in gastric cancer, which represents a pharmacologic intervention that doesn't fit into the other specific categories. Thinking: off label use — Vioxx (rofecoxib) was FDA-approved for pain and arthritis, not for suppressing cancer progression in stomach cancer patients.

✓ Unanimous Initial: off label use Requery: off label use — Rofecoxib (Vioxx) is a COX-II inhibitor approved for pain management and inflammation, but not specifically for cancer treatment, indicating off label use in this context for disseminated stomach cancer. Thinking: off label use — Rofecoxib is an approved COX-2 inhibitor being tested for a new, non-approved indication (palliative treatment of stomach cancer).