Primary objectives: To optimize ex vivo testing procedures for cervical cancer patients derived tumor tissue tumoroids culturing from tissue from the primary tumor.To evaluate the success rate of ex vivo drug sensitivity testing for cervical cancer…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Optimizing procedures for ex-vivo tumor testing for cervical cancer
Evaluation of success rates of ex vivo drug sensitivity testing for cervical
cancer patients eligible for NACT
explorative testing of ex vivo immune drug sensitivity for cervical cancer.
identification of tumor characteristics/ biomarkers/molecular markers that
predict response to multiple neo adjuvant chemotherapy options.
Secondary outcome
To evaluate the correlation between ex vivo drug sensitivity using tumor tissue
derived before chemotherapy and the clinical response in women with cervical
cancer who wish to preserve fertility and are treated with neo-adjuvant
chemotherapy in order to enable less radical surgery.
Background summary
Neo-adjuvant chemotherapy (NACT), which involves administration of chemotherapy
prior to surgical therapy, has become a valid option in cervical cancer,
especially in patients with a desire to become pregnant. The aim of
neo-adjuvant chemotherapy is 2-fold: both down-staging and down-sizing which
would result in more favourable outcome after less radical surgery in case of
fertility sparing surgery (FSS). However, the response to NACT is uncertain:
although most patients tend to respond, in 15-30% of cases no effect is
achieved after NACT. In cases without response to NACT other, possible
effective, treatment is delayed. Until now there is no diagnostic test to
predict responsiveness to NACT in gynaecological cancer in general and cervical
cancer in specific. This protocol evaluates the feasibility to establish ex
vivo testing of tumor tissue from patients who have cervical cancer and will be
submitted to chemotherapy before FSS.
Study objective
Primary objectives: To optimize ex vivo testing procedures for cervical cancer
patients derived tumor tissue tumoroids culturing from tissue from the primary
tumor.
To evaluate the success rate of ex vivo drug sensitivity testing for cervical
cancer patients eligible for NACT
To identify tumor characteristics/ biomarkers/molecular markers that predict
response to multiple neo adjuvant chemotherapy options.
To evaluate drug sensitivity to novel (immune) drugs.
Secondary objective: To evaluate the correlation between ex vivo drug
sensitivity using tumor tissue derived before chemotherapy and the clinical
response in women with cervical cancer who wish to preserve fertility and are
treated with neo-adjuvant chemotherapy in order to enable less radical surgery.
Study design
The study is a prospective cohort pilot study which will be executed at the
gynecological department in two hospitals (LUMC/AVL) and the department of
Pathology (LUMC). Patients will be eligible for this study if they have
cervical cancer (tumor size 2<=4cm) and have a fertility wish. To evaluate if
women are eligible for neo-adjuvant chemotherapy in order to downsize the tumor
size and to allow less radical fertility sparing surgery afterwards, women will
undergo a pelvic lymphadenectomy to exclude metastases. A biopsy from the
tumor will be taken during the pelvic lymphadenectomy.
Study burden and risks
Patients who have cervical cancer (measuring 2<=4 cm) and have a fertility wish
will need one extra biopsy of the tumor during the pelvic lymphadenectomy.
This biopsy will be performed under general anesthesia.
Only small risks are expected, such as local infection or local bleeding.
albinusdreef 2
Leiden 2300RC
NL
albinusdreef 2
Leiden 2300RC
NL
Listed location countries
Age
Inclusion criteria
Patients are eligible for this study in case they meet the following inclusion
criteria:
• Patients must have histologically confirmed invasive cervical cancer with
adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring
>2cm to <=4cm by magnetic radiological imaging (MRI). Lymphovascular space
invasion (LVSI) is allowed.
• Patients must be >=18 years of age, and < 40 years of age
• Patients must be premenopausal and wish to preserve fertility
• At time of registration, patient may not have had any prior therapy to treat
their cancer lesion, patients with diagnostic cone or LEEP are allowed
• Eastern Cooperative Group (ECOG) performance status <= 2 (Karnofsky >=60%, see
Appendix C).
No evidence of active uncontrolled infection (patients on antibiotics are
eligible).
Patient must have disease that is measurable per RECIST 1.1.
• Ability to understand and willing to sign a written informed consent document.
• Patients must agree to use effective contraceptive methods prior to study
entry, during study participation, and for at least one year after the FSS
procedure.
Exclusion criteria
Exclusion criteria for this study:
• Patients who have had chemotherapy or radiotherapy or surgery for their
cancer. Patients with diagnostic cone or LEEP are allowed
• Patients who are receiving any other investigational agents.
• Patients with other cancers requiring ongoing treatment. Patients with
malignancies unrelated to their cervical cancer can be included if they have
not required treatment for 2 years. Patient with baso cellular skin cancer are
allowed.
• Patients with known / evidence of brain metastases are excluded from
participation in this clinical trial.
• History of allergic reactions attributed to compounds of similar chemical or
biologic composition to paclitaxel, carboplatin, or cisplatin or other agents
used in study.
• Uncontrolled inter-current illness including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
would limit compliance with study requirements.
• Patients who are pregnant or breastfeeding
• Any other condition that would, in the Investigator*s judgment,
contraindicate the patient*s participation in the clinical study due to safety
concerns or compliance with clinical study procedures, e.g.,
infection/inflammation, intestinal obstruction, unable to swallow medication,
social/ psychological issues.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL76138.058.20 |