Cervical Cancer
Conditions
Brief summary
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 will be performed.
Detailed description
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. Since low fertility rates after abdominal radical hysterectomy are observed due to the radical surgery performed on the uterine cervix, less radical surgery is warranted. To enable less radical surgery by cervical conisation, neo-adjuvant chemotherapy to reduce tumor size is incorporated to the multi-modal treatment scheme of these patients.
Interventions
DRUGPaclitaxel
weekly paclitaxel 80 mg/m2 for 12 weeks
DRUGCarboplatin
weekly carboplatin AUC=2 for 12 weeks
PROCEDUREconisation
if tumor is reduced to \<2 cm, patients will be treated with a conisation
Sponsors
The Netherlands Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One arm two-stage Simon's design with response to neo-adjuvant chemotherapy as the primary endpoint
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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) * Lymph vascular space invasion allowed (LVSI) * Age ≥18 years and ≤ 40 years * Wish to preserve fertility * Written and signed informed consent * Negative serum or urine pregnancy test within 14 days prior to registration, and an effective method of contraception must be used during treatment * 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 * Laboratory values: serum creatinine \< 140 μmol/L; creatinine clearance \> 60 ml/min(Cockroft formula); white blood cell count \> 3.5 x 109/l; platelets \> 100 x 109 /l
Exclusion criteria
* Other high grade histologies like neuro-endocrine and clearcell carcinoma * FIGO stage Ia, Ib1\< 2 cm, Ib2, II, III and IV disease * 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 malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of neo-adjuvant chemotherapy | week 6 of neoadjuvant treatment | efficacy of neo-adjuvant chemotherapy on tumor response |
| safety of neo-adjuvant chemotherapy | 2 years after conisation | defined as number of women who get recurrence within two years after conisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fertility | 5 years after treatment | number of patients who are still fertile after treatment |
| ovarian function | 2 years after conisation | hormone levels will be measured to evaluate ovarian function |
Countries
Netherlands
Outcome results
None listed