To monitor the effects of radiotherapy alone, chemoradiation and radiotherapy combined with hyperthermia on the immune response and different T cell subsets over time in patients with cervical cancer.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The time-related immuneresponse during and after treatment with radiotherapy in
cervical cancer patients. T cell phenotypic changes and T cell-related immune
cell functional changes will be investigated.
Secondary outcome
N/A
Background summary
Radiotherapy is an important treatment for cervical cancer which can be used in
both a curative and palliative setting. Although radiotherapy is known to
negatively affect lymphoid cells, accumulating evidence indicates that
radiotherapy may also modify the tumour environment and stimulate an
antitumoural immune response. These immunomodulatory properties could predict
collaboration between cancer immunotherapy and radiotherapy in future. However,
the effect of radiotherapy on the general and the HPV16 E6 and E7-specific
immune responses is currently not well evaluated. Therefore the aim of this
exploratory study is to investigate the general and HPV-specific T cell
responses before, during and after radiotherapy.
This study is a part of a combined LUMC / CHDR clinical immunopharmacology
research line.
Study objective
To monitor the effects of radiotherapy alone, chemoradiation and radiotherapy
combined with hyperthermia on the immune response and different T cell subsets
over time in patients with cervical cancer.
Study design
Open, observational, exploratory study
Study burden and risks
All participating patients will be treated with standard radiotherapy, exactly
the same as when they wouldn't participate.
Only some additional blood sampling will take place for study purposes. Blood
sampling will take place during rregular hospital visits.
Albinusdreef 2, postbus 9600
2300 RC Leiden
NL
Albinusdreef 2, postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
- Patients should be at least 18 years of age;
- Patients should be able and willing to provide informed consent;
- Patients should have the clinical diagnosis of cervical cancer;
- Patients are scheduled for:
1. Primary external beam radiotherapy (EBRT) with intra-uterine brachytherapy (BT);
2. Primary EBRT with intra-uterine brachytherapy (BT) and concurrent chemotherapy (Cisplatin);
3. Primary EBRT with intra-uterine brachytherapy (BT) and combined with hyperthermia;
4. Adjuvant, post-operative external beam radiotherapy (EBRT);
5. Adjuvant, post-operative EBRT with concurrent chemotherapy (Cisplatin).
Exclusion criteria
- Any medical condition that may interfere with the study objectives;
- Positive test result for HIV or Hepatitis B;
- Any other active malignancy than cervical cancer.
Design
Recruitment
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 |
|---|---|
| CCMO | NL36829.058.11 |