Clinical trial · Interventional
Stereotactic Radiotherapy (SRT) Liver (COLD 1)
Phase I/II Trial of Highly Conformal Radiotherapy for Unresectable Liver Metastases and Hepatobiliary Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A minority of patients with colorectal liver metastases and hepatobiliary cancer (primary liver cancer) are candidates for surgery, but there are no curative treatment options for these patients. Their median survival time is 3 to 12 months. Stereotactic radiation (SRT) (highly conformal radiotherapy (CRT)) is a treatment option for these patients with unresectable liver cancer, now possible due to improvements in our ability to localize and immobilize liver tumors and an improved understanding of the partial liver volume tolerance to radiation. SRT should permit liver tumors to be treated to tumorcidal doses while sparing the uninvolved liver, decreasing the risk of treatment related normal tissue toxicity. With such conformal radiation, it is possible to deliver radiation in fewer fractions than traditionally required, which should be more convenient for patients. In this study, CRT will be delivered during shallow breathing or breath hold to minimize organ motion due to breathing, decreasing the volume of normal liver that must be irradiated.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiotherapy (SRT) or highly conformal (CRT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic RT or highly conformal RT
- interventionNames
- Procedure: Stereotactic radiotherapy (SRT) or highly conformal (CRT)
Primary outcomes (2)
- measure
- Phase I: To evaluate feasibility and maximally tolerated dose of SRT
- timeFrame
- assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years
- measure
- Phase II: To determine with more confidence the rate and spectrum of all toxicities that occur at the maximally tolerated dose of radiation.
- timeFrame
- assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary hepatobiliary confirmed pathologically or via imaging * Liver metastases from colorectal cancer or other solid malignancy, confirmed pathologically * New radiographic liver lesions most consistent with metastases, in a patient with previously pathologically proven solid malignancy and a previously negative liver contrast CT or MRI * The tumor must be unresectable or the patient must be medically inoperable or extra-hepatic metastases must be present * Karnofsky performance status (KPS) \> 60 * Age \> 18 years * Patients must have recovered from the effects of previous surgery, radiotherapy or chemotherapy * Chemotherapy must be completed at least 2 weeks prior to radiation therapy or not planned to be administered for at least 2 weeks * Adequate organ function as assessed as follows:Hemoglobin \> 90 g/L, Absolute neutrophil count \> 1.5 bil/L, Platelets \> 80,000 bil/L, Bilirubin \< 3.0 times upper range of normal, INR \< 1.3 or correctable with vitamin K, AST or ALT \< 6.0 times upper range of normal, Creatinine \< 200 umol/L (other than patients who are having dialysis or already have dialysis lines in place for future dialysis for renal failure. These patients may be treated on study with no upper limit on their creatinine.) * Child A liver score * Previous liver resection or ablative therapy is permitted. * Life expectancy \> 3 months * Multiple metastases are permitted (volume of uninvolved must be at least 800 cc, and the maximal effective liver volume that may be treated is 80%. * Informed consent form Exclusion Criteria: * Patients with active hepatitis or clinically significant liver failure * Prior radiation therapy to the right upper abdomen, precluding re-irradiation of the liver. (Prior pelvic radiation is permitted, as long as no overlap between pelvic and liver radiation fields occurs.) * Prior uncontrolled, life threatening malignancy within the past year. * Gross (clinically apparent) ascites. * Pregnancy is not permitted, and in women of child bearing age, a pregnancy test and birth control are warranted.
References
Publications (1)
- DERIVEDBujold A, Massey CA, Kim JJ, Brierley J, Cho C, Wong RK, Dinniwell RE, Kassam Z, Ringash J, Cummings B, Sykes J, Sherman M, Knox JJ, Dawson LA. Sequential phase I and II trials of stereotactic body radiotherapy for locally advanced hepatocellular carcinoma. J Clin Oncol. 2013 May 1;31(13):1631-9. doi: 10.1200/JCO.2012.44.1659. Epub 2013 Apr 1. PMID 23547075