Radiation Oncology/RTOG Trials/0438

RTOG 04-38 (LIVER)

  • Title: A Phase I Trial of Highly Conformal Radiation Therapy for Patients with Liver Metastases
  • Objective: To identify the maximally tolerated dose (up to 50 Gy in 5 Gy per fraction) of high dose per fraction, highly conformal radiation therapy in patients with metastatic liver cancer.
  • Protocol:
    • All Patients will receive 10 fractions Monday-Friday for 2 weeks at the following levels; Dose escalation by 0.5 Gy to maximum of 50 Gy, as follows:
Dose level Level I Level II Level III Level IV
Dose / fx 3.5 Gy 4.0 Gy 4.5 Gy 5.0 Gy
Total dose 35 Gy 40 Gy 45 Gy 50 Gy
  • Eligibility:
    • Non-lymphoma liver metastases confirmed pathologically or new radiographic liver lesions most consistent with metastases, in a patient with known, pathologically proven non-lymphoma cancer and a previously negative contrast CT, MRI or PET/CT of the liver
    • <=5 liver lesions, <=6 cm per lesion
  • Treatment details:
    • GTV = tumor by contrast-enhanced CT scan or MRI. CTV = GTV + 5mm, within the liver. PTV = CTV plus setup margin, at least 4 mm and <= 10 mm.
    • Critical structures: "Normal liver" = liver minus GTV. Normal liver should be at least 1000 cc. No more than 30% may receive > 27 Gy. No more than 50% may receive > 24 Gy. Kidney: no more than 33% of both kidneys may receive > 18 Gy. Cord: max dose 34 Gy. Bowel and stomach: max dose 37 Gy to any 1 cc volume.
  • Enrollment Target: 18 patients
  • Activation: Nov 3, 2005