The primary objective is to determine the efficacy of neo-adjuvant chemotherapy to reduce tumour size below 2 cm in diameter and thus enabling conisation.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To demonstrate safety and feasability of the combination of neo-adjuvant
chemotherapy followed by less radical surgery
Secondary outcome
need for adjuvant therapy (radical hysterectomy or (chemo)radiation,
preservation of ovarian function, quality of life.
Background summary
The standard treatment of stage Ib1 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
The primary objective is to determine the efficacy of neo-adjuvant chemotherapy
to reduce tumour size below 2 cm in diameter and thus enabling conisation.
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
Ib1 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 four
courses of weekly neo-adjuvant chemotherapy (12 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 4 time points in this trial. One extra blood sample is taken prior to study
registration. Extra biopsies are taken while under general anesthesia in the
operating theatre just before scheduled surgery (pelvic lymph node dissection
and conisation).
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.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
* Stage Ib1 cervical cancer measuring *2 - *4 cm on physical examination and imaging in any direction
* Histologic type: squamous cell carcinoma (SCC), adeno cell carcinoma (ACC), adeno-squamous cell carcinoma (ASC)
* Age *18 years and * 40 years
* MRI abdomen and pelvis, chest X-ray must be performed and negative for metastatic disease within 12 weeks of enrolment
* No metastases on pelvic lymph node dissection
Exclusion criteria
* Involvement of tumor in uterine corpus on MRI or hysteroscopy if performed
* Evidence of metastatic disease on imagining (PET/CT/MRI) performed within 12 weeks of enrolment
* other diagnosis of malignancy or evidence of other malignancy for 5 years before screening for this study (except non-melanoma skin cancer).
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 |
|---|---|
| EudraCT | EUCTR2017-003102-40-NL |
| ClinicalTrials.gov | NCTnummervolgt |
| CCMO | NL63346.031.18 |