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

NCT ID: NCT03852979

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-01-01

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

neo-adjuvant chemotherapy

The patients are given weekly paclitaxel 80 mg/m2 + carboplatin AUC=2 (or AUC=6 per three weeks) during 12 weeks/4 courses followed by conization if tumor size is reduced to \<2 cm

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

weekly paclitaxel 80 mg/m2 for 12 weeks

Carboplatin

Intervention Type: DRUG

weekly carboplatin AUC=2 for 12 weeks

conisation

Intervention Type: PROCEDURE

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

Interventions

Paclitaxel

weekly paclitaxel 80 mg/m2 for 12 weeks

Intervention Type: DRUG

Carboplatin

weekly carboplatin AUC=2 for 12 weeks

Intervention Type: DRUG

conisation

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NKI-AVL

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

M17CPF

Identifier Type: -

Identifier Source: org_study_id