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AzTrials

Cervical CancerPhase 2NEOCON-FNCT03852979

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

A Phase 2 study testing Paclitaxel, Carboplatin and conisation in people with Cervical Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Paclitaxel, Carboplatin and conisation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteNetherlands
Study dates
1 Nov 2018to 1 Jan 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Netherlands1 site

  • NKI-AVL

    Amsterdam, 1066CX

Other trials in Netherlands

About this study

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.

Read the 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.

Conditions
Cervical Cancer
Being tested
Paclitaxel, Carboplatin, conisation
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    weekly paclitaxel 80 mg/m2 for 12 weeks

  • CarboplatinDrug

    weekly carboplatin AUC=2 for 12 weeks

  • conisationProcedure or surgery

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

Study groups in NCT03852979
Study groupRoleWhat they receive
neo-adjuvant chemotherapyExperimentalThe 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
Receives: Drug: Paclitaxel; Drug: Carboplatin; Procedure: conisation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. efficacy of neo-adjuvant chemotherapy

    efficacy of neo-adjuvant chemotherapy on tumor response

    Measured: week 6 of neoadjuvant treatment

  2. safety of neo-adjuvant chemotherapy

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

    Measured: 2 years after conisation

Secondary outcomes (2)

  1. fertility

    number of patients who are still fertile after treatment

    Measured: 5 years after treatment

  2. ovarian function

    hormone levels will be measured to evaluate ovarian function

    Measured: 2 years after conisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2019
  2. Study start1 Nov 2018
  3. Primary completion1 Jan 2020
  4. Study completion1 Jan 2020

Why it stopped: study is merged with CONTESSA study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
One arm two-stage Simon's design with response to neo-adjuvant chemotherapy as the primary endpoint
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03852979
Sponsor's protocol ID
M17CPF
Acronym
NEOCON-F
Status last verified
Dec 2018
First submitted
5 Dec 2017
Last updated
10 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: to be determined

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Carboplatin and conisation in people with Cervical Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: study is merged with CONTESSA study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

efficacy of neo-adjuvant chemotherapy (time frame: week 6 of neoadjuvant treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03852979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.

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