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| ID | Type | Description | Link |
|---|---|---|---|
| 2012/1392 REK South East C |
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Insuffisient recruitment
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In this study the investigators will include colo-rectal cancer (CRC) patients starting last line of standard palliative chemotherapy. Eligible patients include patients with KRAS mutation starting line or KRAS wild type starting line treatment. Standard treatment today for these patients is chemotherapy only and median overall survival (OS) is about 10 months. The hypothesis is that local treatment in addition to systemic treatment will increase time to progression, progression free survival and overall survival compared to patients who receive systemic chemotherapy only. The investigators experience with local treatment of liver metastases in CRC patients is that side-effects of treatment in general are minor, although gastric bleeding have been observed after stereotactic body radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cheomotherapy and local treatment | Experimental | Standard chemotherapy + local treatment |
|
| Cheomotherapy | Placebo Comparator | Standard chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation, microwave, radiation therapy | Procedure | Radiofrequency ablation Microwave ablation Radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival from time of randomization | 6 months |
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Inclusion Criteria:
Histologically verified adenocarcinoma of colon or rectum
Ambulatory with an ECOG performance status 0-2
At least 18 years of age
Non-resectable liver metastases
Progressive disease on or within 4 months after 1.line chemotherapy for KRAS mutant or after 2.line chemotherapy in KRAS wild type patients
1-4 liver metastases with largest diameter of up to 6 cm on CT-scan
Up to 20 lesions in liver with no more than 4 lesions larger than 4 cm
The patients will start 2./3. line chemotherapy (KRAS mutant/KRAS wt)
Laboratory values as the following:
Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | N-0310 | Norway |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D008872 | Microwaves |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Standard Chemotherapy | Drug |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011846 | Radio Waves |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011840 | Radiation, Nonionizing |