This study has been transitioned to CTIS with ID 2024-512968-57-00 check the CTIS register for the current data. The primary objective of the study is to assess the safety and feasibility of autologous salivary gland stem cell transplantation of the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Head and neck cancer
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the study is to test the safety and the feasibility of
autologous salivary gland stem cell transplantation of the submandibular gland.
For safety, the number of adverse events (AE), serious adverse events (SAE) or
suspected unexpected adverse reactions (SUSAR) after autologous salivary stem
cell transplantation, will be recorded between days 1 to 365. All possible
adverse events will be scored according to the definitions of the Common
Toxicity Criteria for Adverse Events version 4.0 (CTCAEv4.0).
For feasibility, salivary flow rate of the remaining submandibular gland will
be recorded 6 months and 12 months after autologous stem cell transplantation.
Secondary outcome
- Unstimulated whole saliva, paraffin stimulated whole saliva and 5% citric
acid stimulated parotid and submandibular/sublingual saliva at 6 and 12 months
and then on a yearly basis until 5 years after postoperative (chemo)radiation
- Patient-rated outcome measures including various side effects related to the
postoperative (chemo)radiation and Quality of Life (QoL) at 6 and 12 months and
then on a yearly basis until 5 years after (chemo)radiation using
internationally validated questionnaires (GRIX, EORTC QLQ-H&N35, EORTC QLQ-C30)
- Locoregional control
- Overall survival and disease free survival
- The rate of water diffusion in remaining submandibular gland derived from
DWI-MRI at 6 and 12 months after postoperative (chemo)radiation.
- The amount of prostate specific membrane antigen (PSMA) in the remaining
submandibular gland derived from PET-CT
Background summary
The majority of patients with head and neck cancer are treated with
radiotherapy, either as single modality or in combination with surgery and/or
systemic agents. Despite the beneficial effects of radiotherapy regarding
loco-regional tumor control, damage inflicted to surrounding salivary glands
cause permanent xerostomia (hyposalivation), which severely hamper the quality
of life (QoL) as reported by patients.
In salivary glands, radiation damage is due to sterilization of the tissues*
endogenous gland stem cells rendering them incapable to replenish dysfunctional
or dead saliva producing cells. Increasing the regenerative potential of
salivary glands by stem cell therapy after irradiation should be able to
restore salivary gland function.
Study objective
This study has been transitioned to CTIS with ID 2024-512968-57-00 check the CTIS register for the current data.
The primary objective of the study is to assess the safety and feasibility of
autologous salivary gland stem cell transplantation of the submandibular gland.
Study design
The study design is a phase I safety and feasibility study to treat head and
neck cancer patients with autologous salivary gland stem cell transplantation
after postoperative radiotherapy.
Intervention
Autologous transplantation of salivary stem cells (salisphere derived cells)
cultured in vitro as obtained from submandibular glands after postoperative
radiotherapy.
Study burden and risks
Patients participating in the study follow the normal procedure of primary
tumour resection, ipsilateral neck dissection and postoperative radiotherapy
(with or without chemotherapy) as indicated by current national standards.
Extra burden of these patients, will be two additional salivary flow
measurements, four MRI scans, four PSMA-PET scans and the ultrasound guided
injection of submandibular salivary gland stem cells in the remaining
submandibular gland.
The additional risk for participating patients might be a mild local infection
(<10%) at the site of injection of the salivary stem cells into the remaining
submandibular gland after transplantation. Another highly unlikely risk (<0.1%)
is a transplanted tumour from the original removed head and neck cancer in the
remaining submandibular gland.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Squamous cell carcinoma (SCC) originating from the mucosa of the oral cavity
- Primary resection of tumour including an electively or therapeutic
ipsilateral neck dissection (at least levels Ib to III, including the
submandibular gland)
- Postoperative radiotherapy or chemoradiation, including prophylactic or
therapeutic irradiation of the contralateral side of the neck (where the
remaining submandibular gland is), including at least levels Ib to IV), next to
irradiation of the tumour bed and ipsilateral neck (current standard)
- Age >= 18 years
- WHO performance 0-2
- Written informed consent
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)
- History within the past five years of malignancies other than:
o basal or squamous cell carcinoma of the skin
o in situ carcinoma of the cervix
- Females who are pregnant or lactating at entry
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-512968-57-00 |
| EudraCT | EUCTR2020-000966-41-NL |
| ClinicalTrials.gov | NCT04593589 |
| CCMO | NL75095.000.20 |