Overview

Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility

Status:
Terminated
Trial end date:
2020-01-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Netherlands Cancer Institute
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Paclitaxel
Criteria
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