Adaptive Radiation for Abdominopelvic Metastases
Single arm Phase I trial of adaptive stereotactic body radiation (SBRT) for abdominopelvic metastases. Adaptive SBRT will allow for escalation of the prescription dose and target coverage while maintaining grade 3+ toxicity no greater than 10%. Subjects with metastatic cancer to the abdomen or pelvis requiring local co
| Condition(s) | Neoplasm - Soft Tissue Pelvis Malignant Secondary, Malignant Neoplasm of Stomach |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | Single arm Phase I trial of adaptive stereotactic body radiation (SBRT) for abdominopelvic metastases. Adaptive SBRT will allow for escalation of the prescription dose and target coverage while maintaining grade 3+ toxicity no greater than 10%. Subjects with metastatic cancer to the abdomen or pelvis requiring local control or palliation will be enrolled. |
| Who can participate | Inclusion Criteria: 1. Subjects must have histologically or cytologically confirmed cancer that is metastatic (all solid tumor types accepted), with at least one target lesion untreated by radiation, IR techniques, or growing in the abdomen or pelvis. Adjacent lymph nodes in the same region (5 cm or closer) constitute one active lesion. Target lesion must be measurable according to RECIST v 1.1. Previous systemic therapies are allowed. 2. Age \> 18 years. 3. ECOG performance status 0 or 1 4. Estimated survival of \>/= 12 months 5. Subjects must have normal organ and marrow function as defined below * Absolute neutrophil count \> 1,500/mcL * Platelets \> 100,000/mcL * Total bilirubin \< 2 mg/dL * AST/ALT (SGOT/SGPT) \< 5X ULN * Creatinine \< 1.5X ULN OR * Creatinine clearance ≥ 50 ml/min/1. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fox Chase Cancer Center |
| Locations | Philadelphia, Pennsylvania, United States |
| Start date | 2023-08-01 |
| NCT ID | NCT05880667 |
| Official listing | https://clinicaltrials.gov/study/NCT05880667 |