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

• ClinicalTrials.gov Identifier: NCT03852979
• Recruitment Status: Terminated
• First Posted: February 25, 2019
• Last Update Posted: January 10, 2020
• Sponsor: The Netherlands Cancer Institute
• Information provided by (Responsible Party): The Netherlands Cancer Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cervical Cancer	Drug: Paclitaxel; Drug: Carboplatin; Procedure: conisation	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: One arm two-stage Simon's design with response to neo-adjuvant chemotherapy as the primary endpoint
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
• Actual Study Start Date: November 1, 2018
• Actual Primary Completion Date: January 1, 2020
• Actual Study Completion Date: January 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. efficacy of neo-adjuvant chemotherapy [ Time Frame: week 6 of neoadjuvant treatment ]
   efficacy of neo-adjuvant chemotherapy on tumor response
2. safety of neo-adjuvant chemotherapy [ Time Frame: 2 years after conisation ]
   defined as number of women who get recurrence within two years after conisation

Secondary Outcome Measures :

1. fertility [ Time Frame: 5 years after treatment ]
   number of patients who are still fertile after treatment
2. ovarian function [ Time Frame: 2 years after conisation ]
   hormone levels will be measured to evaluate ovarian function

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Netherlands

NKI-AVL

Amsterdam, Netherlands, 1066CX

Sponsors and Collaborators

The Netherlands Cancer Institute

More Information

• Responsible Party: The Netherlands Cancer Institute
• ClinicalTrials.gov Identifier: NCT03852979
• Other Study ID Numbers: M17CPF
• First Posted: February 25, 2019
• Last Update Posted: January 10, 2020
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: to be determined

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Paclitaxel; Carboplatin; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action