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Study was stopped in agreement with investigator due to slow recruitment.
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Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size.
The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction of the imILT treatment method performed pecutaneously in patients diagnosed with pancreatic cancer. The purpose is also to investigate the functionality and safety of the method.
This trial is an open-label, double-arm study. Twenty patients diagnosed with pancreatic cancer will be treated in this trial, ten recieving imILT treatment and ten recieving standard chemotherapy. The study is estimated to be carried out during a time period of 21 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| imILT treatment | Experimental | Immunostimulating Interstitial Laser Thermotherapy (imILT) |
|
| Standard chemotherapy treatment | Active Comparator | This study arm recieves chemotherapy treatment as standard care at the clinical study site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imILT | Device | The imILT treatment arm recieves imILT treatment and no simultaneous chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment effect by radiology | Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by the incidence the of adverse events | Evaluation of adverse events and laboratory analyses. | 12 months |
| Usability (user evaluation of instrument) | Analysis of instrument and user questionnaires relating to the ease of use. |
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Inclusion Criteria:
A diagnosis of non-resectable pancreatic adenocarcinoma by form of either locally advanced disease (stage II-III) or of stage IV disease with hepatic metastasis (staging according to UICC 2009)
Locally advanced disease shall have a lesion diameter less than 4cm
If stage IV disease, the patient shall have only liver metastasis, with less than 5 in number, each one less than 4 cm in diameter
The patient is a candidate for standard chemotherapy (as described at point 5.1)
Age between 18 and 80 years, males and females
Anticipated compliance with treatment and follow-up
Have given informed verbal and written consent to participation in the trial
Have stable and adequate haematologic, renal and hepatic functions:
At least a part of the tumour can be treated with imILT without damage to adjacentvital structures
Have an ECOG performance status <2 (Karnofsky> 60%)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Belarmino Goncalves, MD | Portuguese Oncology Institute of Porto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portuguese Oncology Institute of Porto | Porto | 4200-072 | Portugal |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Standard chemotherapy treatment | Drug | The standard chemotherapy treamtment arm recieves only chemotherapy. |
|
| 12 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |