Trials
Search / Trial NCT06427460

Central-boost Ablative Radiation Therapy for Solid Tumors (CBART)

Launched by CHANGHAI HOSPITAL · May 19, 2024

Trial Information

Current as of February 18, 2025

Recruiting

Keywords

Pancreatic Cancer Stereotactic Body Radiation Therapy Inner Gross Tumor Volume Central Boost Ablative Radiation Dose

ClinConnect Summary

The clinical trial titled "Central-boost Ablative Radiation Therapy for Solid Tumors" (CBART) is studying a new way to treat pancreatic cancer and other solid tumors. The researchers want to see if a special type of radiation therapy, called stereotactic body radiation therapy (SBRT), can safely deliver high doses of radiation to large tumors without harming nearby organs. This trial is currently looking for participants aged 18 to 75 who have confirmed cases of pancreatic, lung, liver, or retroperitoneal tumors, especially if they have small areas of cancer spread elsewhere in the body.

To be eligible, participants should have tumors that are at least 2 centimeters in size or very close to sensitive organs, and they should be in good overall health (with a score of 0 to 1 on a specific performance scale). Those who have had radiation therapy for their tumor before or have certain health issues, like severe heart or lung problems, may not qualify. If you join the study, you'll receive this new radiation treatment, and the doctors will closely monitor your health and any side effects. This trial offers a potential new option for patients with challenging tumors that traditional treatments may not effectively target.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Aged 18-75 years.
  • Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor.
  • Oligometastasis in the case of metastatic tumor
  • the shortest diameter ≥2cm or the distance from the tumor to the organs at risk less than 5mm
  • ECOG of 0 to 1 point
  • No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10\^9/L, neutrophil count ≥2.0×10\^9, hemoglobin level ≥100g/L, platelet count ≥100×10\^9/L, ALT and AST level \< 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio \<2)
  • Exclusion Criteria:
  • History of radiotherapy for the lesion
  • History of tumor within 5 years
  • ECOG ≥2 points
  • Significant abnormality in blood routine test, liver and kidney function test and coagulation test
  • Active inflammatory bowel disease in the case of pancreas or retroperitoneal tumor
  • Gastrointestinal bleeding or perforation within 6 months in the case of pancreas or retroperitoneal tumor
  • Infections required antibiotics
  • Heart or respiratory insufficiency
  • Pregnant or breastfeeding women

Trial Officials

Huojun Zhang, M.D.

Principal Investigator

Changhai Hospital

About Changhai Hospital

Changhai Hospital is a leading medical institution dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to excellence, the hospital integrates cutting-edge medical technologies and a multidisciplinary approach to patient care. Changhai Hospital actively collaborates with research organizations and healthcare professionals to conduct rigorous clinical trials aimed at developing new treatments and improving patient outcomes. By prioritizing patient safety and ethical standards, the hospital plays a pivotal role in contributing to the advancement of medical knowledge and the enhancement of therapeutic options.

Locations

Shanghai, Shanghai, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0