Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility (NEOCON-F)

Netherlands Cancer Institute (NKI)

Status and phase: Terminated; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: Carboplatin; Procedure: conisation; Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT03852979

M17CPF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

neo-adjuvant chemotherapy

Experimental group

Description:

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

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Procedure: conisation