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| ID | Type | Description | Link |
|---|---|---|---|
| ASCO Clinical Research Grant |
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| Name | Class |
|---|---|
| American Society of Clinical Oncology | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic RT or highly conformal RT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic radiotherapy (SRT) or highly conformal (CRT) | Procedure | SRT or CRT is radiation delivered precisely conforming the high dose region to the tumor, usually in a few highdose fractions. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: To evaluate feasibility and maximally tolerated dose of SRT | assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years | |
| Phase II: To determine with more confidence the rate and spectrum of all toxicities that occur at the maximally tolerated dose of radiation. | assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate local control, progression-free survival and survival of patients with unresectable primary hepatobiliary cancer and metastatic liver cancer treated with SRT. | assessment: weekly during treatment; 1, 3, 6, 9, 12 months post, every 6 months for up to 3 years | |
| To evaluate the quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Dawson, MD | Princess Margaret Hospital, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23547075 | Derived | Bujold 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. |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| assessment: pre-treatement, 1, 3, 6,12 months post |
| To evaluate changes in liver function following SRT. | 3 to 12 months |
| To evaluate patterns of breathing at and during RT. | during radiation treatment only |
| To develop more confidence in a revised normal tissue complication probability (NTCP) model for radiation induced liver toxicity and collect preliminary data to determine how the liver responds to radiation. | at 3 months post RT |
| To determine whether serum cytokines and P-III-P can help predict RILD. | baseline, during radiation and up to 3 months post radiation |
| D008107 |
| Liver Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |