CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 67 target
Drug / intervention
Central-boost ablative dose delivered by stereotactic body radiation therapyradiation
Likely dose
Not stated in record
Key inclusion· 5
  • Aged 18-75 years
  • Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor
  • Oligometastasis in metastatic tumor
  • Tumor ≥2cm or distance to organs at risk <5mm
Key exclusion· 9
  • Prior radiotherapy for the lesion
  • History of malignancy within 5 years
  • ECOG ≥2
  • Significant abnormality in blood routine, liver/kidney function, or coagulation tests

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06427460
NCT06427460Phase 2RecruitingUpdate OverdueUpdated 25mo ago · Completion was 12mo ago
Enrollment Stalled
Update Overdue

Central-boost Ablative Radiation Therapy for Large Tumors or Tumors Adjacent to Organs at Risk

Changhai Hospital·interventional·Posted May 23, 2024·Updated May 23, 2024

In Brief

A Phase 2 clinical trial evaluating Central-boost ablative dose delivered by stereotactic body radiation therapy for Pancreatic Cancer. Currently recruiting, targeting 67 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

In the case of large tumors or tumors closely adjacent to organs at risk, ablative doses offered by stereotactic body radiation therapy (SBRT) could not be delivered. Therefore, a technique that could provide high radiation doses to tumors without increasing of risks of severe adverse effects is required.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
202520262027
First PostedMay 23, 2024
Enrollment StartMay 12, 2024
Primary CompletionJun 30, 2025
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.1 years ago

Interventions

Central-boost ablative dose delivered by stereotactic body radiation therapyradiation

An inner and complete gross tumor volume (iGTV) is created within the gross tumor volume (GTV). For the liver or lung tumor, the convetional radiation dose is 35-45Gy/5f. Regarding the pancreatic tumor or retroperitoneal tumor, the radiation dose is 30-40Gy/5f. Hence, the radiation dose of iGTV should not be less than 120% of the dose of GTV.