Heat-Activated Target Therapy of Local-Regional Relapse in Breast Cancer Patients (EURO-DIGNITY)
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|ClinicalTrials.gov Identifier: NCT02850419|
Recruitment Status : Suspended (Administrative)
First Posted : August 1, 2016
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: ThermoDox (Thermally Sensitive Liposomal Doxorubicin) Radiation: Radiation Therapy Device: Superficial Hyperthermia||Phase 2|
Locoregional recurrence of breast cancer (LRR) after mastectomy is a clinically challenging problem. Between 5% and 35% of women with operable breast cancer will experience an isolated LRR following their primary treatment, usually within 5 years of initial mastectomy. LRR or LR typically causes pain, lymphedema, and/or loss of freedom of movement. Therapeutic options usually involve resection, radiation or, at some specialized centers, combined radiation and hyperthermia. However, local control remains suboptimal in previously irradiated chest wall patients with the combination of radiation and hyperthermia providing local control rates of about 65%.
Lyso-thermosensitive liposomal doxorubicin (LTLD) is a temperature sensitive liposome which is systemically administered and is engineered to selectively release its doxorubicin contents when exposed to temperatures ≥ 39.5°C.
Local mild hyperthermia (40 to 44°C) is cytotoxic and is known to have an immunomodulatory effect along with a radiation and chemosensitizing effect in the heated tissue. Furthermore, mild hyperthermia enhances leakiness of tumor tissue, increases local perfusion and upregulates transvascular transport of doxorubicin.
Radiation therapy will be administered in this combination therapy.
This study evaluates the application of a tri-modal approach with LTLD to improve outcome: radiation, hyperthermia, and targeted release of a novel formulation of doxorubicin.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Heat-Activated Target Therapy (Radiotherapy + Hyperthermia + Lyso-Thermosensitive Liposomal Doxorubicin) of Local-Regional Relapse in Breast Cancer Patients|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||February 2020|
Experimental: ThermoDox (40mg/m2)+hyperthermia+RT
Treatment will consist of up to six cycles of LTLD combined with hyperthermia every 21 days with the first day of each cycle being Day 1. ThermoDox will be administered at a dose of 40 mg/m2. Thermal dose is a one-hour treatment at a temperature between 40 and 43°C at the target site. At Cycle 1, radiotherapy will begin and will be combined with hyperthermia. A total of 40 Gy in 20 fractions of 2 Gy per fraction will be administered. Up to 66 Gy of radiation therapy can be administered however institutional guidelines should be followed.
Drug: ThermoDox (Thermally Sensitive Liposomal Doxorubicin)
A dose of 40 mg/m2 will be administered at each cycle for a total of 6 cycles. ThermoDox will be administered in conjunction with hyperthermia.
Radiation: Radiation Therapy
A total of 40 Gy in 20 fractions of 2 Gy per fraction will be administered. Up to 66 Gy of radiation therapy can be administered however institutional guidelines should be followed.
Device: Superficial Hyperthermia
Thermal dose is an one-hour treatment at a temperature between 40 and 43 degrees Celsius at the target site.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 12 months ]
- Loco-regional breast tumor control in patient who underwent ThermoDox + hyperthermia + radiotherapy as measured by target lesion clinical response rate combining RECIST criteria with digital photography to gauge response. [ Time Frame: Up to 18 months ]
- Duration of local control [CR (complete response), PR (partial response) and SD (stable disease) following treatment with ThermoDox + Hyperthermia + Radiotherapy up to 12 months among patients with LRR breast cancer. [ Time Frame: Up to 18 months ]
- Patient Reported Quality of Life using the FACT-B following treatment with ThermoDox + Hyperthermia + Radiotherapy among patients with LRR breast cancer. [ Time Frame: Up to 18 months ]
- Patient Reported Quality of Life using the Brief Pain Inventory (BPI) following treatment with ThermoDox + Hyperthermia + Radiotherapy among patients with LRR breast cancer. [ Time Frame: Up to 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850419
|Inst. of Radiation Oncology Hospital Na Bulovce|
|Rambam Health Care Campus|
|Fondazione Del Piemonte Per L'Oncologia - Irccs Candiolo|
|Principal Investigator:||Pietro Gabriele, M.D.||FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA - IRCCS CANDIOLO|