This study has been transitioned to CTIS with ID 2023-507230-24-00 check the CTIS register for the current data. To assess the feasibility of preserving fertility in women with 2018 FIGO stage IB2 cervical cancer with lesions measuring >2 cm -
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
to determine the rate of functional uterus defined as successful fertility
sparing surgery (FSS) with no adjuvant therapy
Secondary outcome
response rate based on RECIST 1.1 following neoadjuvant chemotherapy
safety of the fertility sparing surgery (FSS)
overall survival (OS)
Background summary
The standard treatment of stage Ib2 2-4 cm cervical cancer in women who wish to
preserve fertility is an abdominal radical trachelectomy with pelvic lymph node
dissection. Since the number of take home babies after completing this
procedure is below 10%, there is a need for exploration of alternative
treatment modalities with better chances of preserving fertility at equal risk
of recurrence.
Study objective
This study has been transitioned to CTIS with ID 2023-507230-24-00 check the CTIS register for the current data.
To assess the feasibility of preserving fertility in women with 2018 FIGO stage
IB2 cervical cancer with lesions measuring >2 cm - <=4 cm.
Study design
This is a prospective, multi-center phase II open label non-randomized trial
evaluating the outcomes of performing less radical surgery in women with stage
Ib2 2-4 cm cervical cancer with no pelvic lymph node metastases and adequate
response to neo-adjuvant chemotherapy, who wish to preserve their fertility
Intervention
If no metastases are observed, patients will start a short protocol of three
courses of weekly neo-adjuvant chemotherapy (9 weeks). If response to
chemotherapy results in a tumor of less than 2 cm, cervical conisation or a
simple trachelectomy/portio amputation with application of a cerclage will be
performed
Study burden and risks
Burden: Patients will undergo a sequential treatment of surgery (pelvic lymph
node dissection), followed by neo-adjuvant chemotherapy and conisation. This
process takes several months and is more time consuming than the current
standard treatment of radical abdominal trachelectomy with pelvic lymph node
dissection in one session. Patients will be asked to fill in QoL questionnaires
at 9 time points in this trial.
Risk: recurrence of disease, short-term and long-term side effects of
chemotherapy (bone marrow depression, opportunistic infections, neurotoxic side
effects, reduced fertility).
Benefit: women are expected to have better chances to become pregnant and have
less immature and premature deliveries. Due to less radical surgery, women are
expected to have less side effects on rectal-, bladder and sexual function.
700 University Ave, 7th floor 700
Toronto, ON M5G 1X6
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700 University Ave, 7th floor 700
Toronto, ON M5G 1X6
CA
Listed location countries
Age
Inclusion criteria
Patients must have histologically confirmed invasive cervical cancer with
adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring
>2 cm - <=4 cm
Patients must be >=18 years of age, and < 40 years of age
Patients must be premenopausal and wish to preserve fertility
no prior therapy to treat their cancer lesion, patients with diagnostic cone or
LEEP are allowed but a measurable tumor of >2 cm - <=4 cm is mandatory
Eastern Cooperative Group (ECOG) performance status <= 2
Within 7 days of the proposed start of treatment, patients must have normal
organ and marrow function
No evidence of active uncontrolled infection
Patient must have disease that is measurable per RECIST 1.1.
Ability to understand and willing to sign a written informed consent document.
A negative serum pregnancy test
Exclusion criteria
Patients who are receiving any other investigational agents.
Patients with other cancers requiring ongoing treatment.
Patients with known / evidence of brain metastases
Uncontrolled inter-current illness
Patients who are pregnant or breastfeeding
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 | CTIS2023-507230-24-00 |
| EudraCT | EUCTR2020-000404-11-NL |
| ClinicalTrials.gov | NCT04016389 |
| CCMO | NL72658.031.20 |