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

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.

Study Overview

• Status: Terminated
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: Paclitaxel; Drug: Carboplatin; Procedure: conisation

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066CX
    • NKI-AvL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Paclitaxel; weekly paclitaxel 80 mg/m2 for 12 weeks; Drug: Carboplatin; weekly carboplatin AUC=2 for 12 weeks; Procedure: conisation; if tumor is reduced to <2 cm, patients will be treated with a conisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of neo-adjuvant chemotherapy	efficacy of neo-adjuvant chemotherapy on tumor response	week 6 of neoadjuvant treatment
safety of neo-adjuvant chemotherapy	defined as number of women who get recurrence within two years after conisation	2 years after conisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fertility	number of patients who are still fertile after treatment	5 years after treatment
ovarian function	hormone levels will be measured to evaluate ovarian function	2 years after conisation

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: M17CPF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: to be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No