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

Primary Purpose

Cervical Cancer

Status

Terminated

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Paclitaxel

Carboplatin

conisation

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

NKI-AVL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

neo-adjuvant chemotherapy

Arm 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

Outcomes

Primary Outcome Measures

efficacy of neo-adjuvant chemotherapy

efficacy of neo-adjuvant chemotherapy on tumor response

safety of neo-adjuvant chemotherapy

defined as number of women who get recurrence within two years after conisation

Secondary Outcome Measures

fertility

number of patients who are still fertile after treatment

ovarian function

hormone levels will be measured to evaluate ovarian function

Full Information

NCT ID

NCT03852979

First Posted

December 5, 2017

Last Updated

January 7, 2020

Sponsor

The Netherlands Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT03852979

Brief Title

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

Acronym

NEOCON-F

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Terminated

Why Stopped

study is merged with CONTESSA study

Study Start Date

November 1, 2018 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Netherlands Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

One arm two-stage Simon's design with response to neo-adjuvant chemotherapy as the primary endpoint

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

neo-adjuvant chemotherapy

Arm Type

Experimental

Arm 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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

weekly paclitaxel 80 mg/m2 for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

weekly carboplatin AUC=2 for 12 weeks

Intervention Type

Procedure

Intervention Name(s)

conisation

Intervention Description

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

Primary Outcome Measure Information:

Title

efficacy of neo-adjuvant chemotherapy

Description

efficacy of neo-adjuvant chemotherapy on tumor response

Time Frame

week 6 of neoadjuvant treatment

Title

safety of neo-adjuvant chemotherapy

Description

defined as number of women who get recurrence within two years after conisation

Time Frame

2 years after conisation

Secondary Outcome Measure Information:

Title

fertility

Description

number of patients who are still fertile after treatment

Time Frame

5 years after treatment

Title

ovarian function

Description

hormone levels will be measured to evaluate ovarian function

Time Frame

2 years after conisation

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

NKI-AVL

City

Amsterdam

ZIP/Postal Code

1066CX

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

to be determined

Learn more about this trial

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

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