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| ID | Type | Description | Link |
|---|---|---|---|
| NL75095.000.20 | Registry Identifier | CCMO register |
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This study is a phase I safety and feasibility study to treat head and neck cancer patients with autologous salivary gland stem cell transplantation after postoperative (chemo)radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplantation | Experimental | Submandibular Gland Stem Cell Transplantation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Submandibular Gland Stem Cell Transplantation | Other | Autologous transplantation of salivary stem cells (salisphere derived cells) cultured in vitro as obtained from submandibular glands after postoperative radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: adverse events | The number of adverse events (AE), serious adverse events (SAE) or suspected unexpected adverse reactions (SUSAR) after autologous salivary stem cell transplantation. All possible adverse events will be scored according to the definitions of the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAEv4.0). | Data for assessing safety will be recorded from day 1 to 365. |
| Feasibility: salivary flow rate | The salivary flow rate of the remaining submandibular gland will be recorded. | Data for assessing feasibility will be recorded 6 and 12 months after autologous stem cell transplantation to assess if salivary flow will be increased compared to salivary flow before transplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary flow recovery | Unstimulated whole saliva, paraffin stimulated whole saliva and 5% citric acid stimulated parotid and submandibular/sublingual saliva measurements. | Saliva measurements at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation |
| Impact of transplantation |
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Inclusion Criteria:
Exclusion Criteria:
Primary (definitive) radiotherapy, with or without systemic treatment;
Previous radiotherapy of the head and neck region (re-irradiation);
Positive microbiological screening for Human Immunodeficiency Virus type 1 and 2, hepatitis B and C virus and Treponema pallidum.
Presence of systemic disease known to affect salivary gland functioning (e.g., Sjögren's syndrome);
Known allergy to mice and gentamicin
History within the past five years of malignancies other than:
Females who are pregnant or lactating at entry.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| R.J.H.M. Steenbakkers, MD, PhD | Contact | +31 (0)503610034 | r.steenbakkers@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| R.J.H.M. Steenbakkers, MD, PhD | UMC Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMCG | Recruiting | Groningen | Netherlands |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Patient-rated outcome measures including various side effects related to the postoperative (chemo)radiation and Quality of Life (QoL) using internationally validated questionnaires. |
| Patient-rated outcome measures at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation |
| Locoregional control | Locoregional control is defined as the number of patients with recurrent disease within or adjacent to the primary tumor site and regional lymph nodes after postoperative (chemo)radiation, assessed by pathology and/or oncologic imaging (CT, MRI or PET). | 5 years after postoperative (chemo)radiation |
| Overall survival and disease-free survival | 5 years after postoperative (chemo)radiation |
| Rate of water diffusion in remaining submandibular gland | The rate of water diffusion in remaining submandibular gland derived from DWI/DTI-MRI. | 6 and 12 months after postoperative (chemo)radiation |
| Amount of PSMA | The amount of prostate specific membrane antigen (PSMA) in the remaining submandibular gland derived from PET-CT | 6 and 12 months after autologous stem cell transplantation |