Status:
TERMINATED
Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
Lead Sponsor:
The Netherlands Cancer Institute
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
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, ce...
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 hom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03852979
Start Date
November 1 2018
End Date
January 1 2020
Last Update
January 10 2020
Active Locations (1)
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1
NKI-AVL
Amsterdam, Netherlands, 1066CX