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

Cervical Cancer Clinical Trial

— NEOCON-F  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03852979
• Other study ID #: M17CPF
• Status: Terminated
• Phase: Phase 2
• Start date: November 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: December 2018
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Paclitaxel
weekly paclitaxel 80 mg/m2 for 12 weeks
• Carboplatin
weekly carboplatin AUC=2 for 12 weeks

Procedure:
• conisation
if tumor is reduced to <2 cm, patients will be treated with a conisation

Locations

Country	Name	City	State
Netherlands	NKI-AVL	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of neo-adjuvant chemotherapy	efficacy of neo-adjuvant chemotherapy on tumor response	week 6 of neoadjuvant treatment
Primary	safety of neo-adjuvant chemotherapy	defined as number of women who get recurrence within two years after conisation	2 years after conisation
Secondary	fertility	number of patients who are still fertile after treatment	5 years after treatment
Secondary	ovarian function	hormone levels will be measured to evaluate ovarian function	2 years after conisation