NCT03852979

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 10, 2020

Status Verified

December 1, 2018

Enrollment Period

1.2 years

First QC Date

December 5, 2017

Last Update Submit

January 7, 2020

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • fertility

    5 years after treatment

  • ovarian function

    2 years after conisation

Study Arms (1)

neo-adjuvant chemotherapy

EXPERIMENTAL

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: PaclitaxelDrug: CarboplatinProcedure: conisation

Interventions

PaclitaxelDRUG

weekly paclitaxel 80 mg/m2 for 12 weeks

neo-adjuvant chemotherapy
CarboplatinDRUG

weekly carboplatin AUC=2 for 12 weeks

neo-adjuvant chemotherapy
conisationPROCEDURE

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

neo-adjuvant chemotherapy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NKI-AVL

Amsterdam, 1066CX, Netherlands

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

PaclitaxelCarboplatinConization

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: One arm two-stage Simon's design with response to neo-adjuvant chemotherapy as the primary endpoint
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2017

First Posted

February 25, 2019

Study Start

November 1, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

January 10, 2020

Record last verified: 2018-12

Locations

NL(1)