AzTrials
AzTrials

Cervical CancerPhase 3NCT00039338

Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical Cancer

A Phase 3 study testing conventional surgery, neoadjuvant chemotherapy and brachytherapy in people with Cervical Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 24 sites in 8 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
conventional surgery, neoadjuvant chemotherapy and brachytherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
686 participants
Where
24 sitesin 8 countries
Study dates
Mar 2002to Jul 2019
Phase
Phase 3
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed cervical cancer, including the following subtypes:
  • Squamous cell carcinoma
  • Adenosquamous cell carcinoma
  • Adenocarcinoma (excluding small cell, clear cell, and other rare variants of the classical adenocarcinoma)
  • FIGO stage IB2, IIA (greater than 4 cm), or IIB

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.46 mg/dL

Renal:

  • Creatinine clearance greater than 60 mL/min

Other:

  • No other prior or concurrent malignancy except adequately treated basal cell skin cancer
  • No psychological, familial, sociological, or geographical condition that would preclude study
  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Not specified

Other:

  • No other concurrent anticancer agent

Trial locations and contacts

24 sites in 8 countries.

24 sites in 8 countries

Netherlands7 sites

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ

  • Vrije Universiteit Medisch Centrum

    Amsterdam

  • Medisch Spectrum Twente

    Enschede

  • Leiden University Medical Center

    Leiden

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen

  • Erasmus MC - Daniel den Hoed Cancer Center

    Rotterdam, 3008 AE

  • Universitair Medisch Centrum - Academisch Ziekenhuis

    Utrecht

Other trials in Netherlands

Italy6 sites

  • Istituto Europeo Di Oncologia

    Milan

  • Ospedale San Gerardo

    Monza

  • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori

    Naples

  • Ospedale Mauriziano Umberto I

    Torino, 10128

  • Clinica Universitaria

    Turin, 10126

  • Ospedale di Circolo e Fondazione Macchi

    Varese

Other trials in Italy

Belgium3 sites

  • Universitair Ziekenhuis Antwerpen

    Edegem

  • U.Z. Gasthuisberg

    Leuven

  • Centre Hospitalier Regional de la Citadelle

    Liège, 4000

Other trials in Belgium

United Kingdom3 sites

  • NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre

    Glasgow, Scotland

  • Mid Kent Oncology Centre

    Maidstone, Kent

  • Queen Elizabeth The Queen Mother Hospital

    Margate, England

Other trials in United Kingdom

Austria2 sites

  • Karl-Franzens-University Graz

    Graz

  • Kaiser Franz Josef Hospital

    Vienna

Other trials in Austria

France1 site

  • Centre Regional Francois Baclesse

    Caen

Other trials in France

Portugal1 site

  • Hospitais da Universidade de Coimbra (HUC)

    Coimbra

Other trials in Portugal

Spain1 site

  • Hospital Universitario San Carlos

    Madrid

Other trials in Spain

About this study

Official title: Randomized Phase III Study Of Neoadjuvant Chemotherapy Followed By Surgery Vs. Concomitant Radiotherapy And Chemotherapy In FIGO Ib2, IIa>4 cm or IIb Cervical Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective followed by surgery or combined with radiation therapy in treating cervical cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer.

Read the detailed description

OBJECTIVES:

  • Compare the overall and progression-free survival of patients with stage IB2, IIA, or IIB cervical cancer treated with neoadjuvant cisplatin-based chemotherapy followed by radical hysterectomy vs standard therapy comprising concurrent radiotherapy and cisplatin-based chemotherapy.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, FIGO stage, age (18 to 50 vs 51 to 75), and histological subtype (adenomatous vs non-adenomatous component). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive neoadjuvant cisplatin-based chemotherapy on day 1. Treatment repeats every 21 days. Within 6 weeks after the last chemotherapy course, patients undergo a type III-V Piver-Rutledge radical hysterectomy. Patients with positive lymph nodes or tumor invasion into the parametria or less than 5 mm from the resection borders after surgery receive standard adjuvant external beam radiotherapy once daily, 5 days a week, for 5-5.6 weeks (25-28 treatment days) followed by external boost radiotherapy or brachytherapy for 1 or 2 days.
  • Arm II: Patients receive standard therapy comprising radiotherapy as in arm I concurrently with cisplatin-based chemotherapy once weekly for 6 weeks. Adjuvant hysterectomy is allowed, but not recommended, in case of histologically proven residual tumor.

Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. For patients in both arms, cisplatin may be combined with other chemotherapeutics as long as the minimum platinum dose is given.

Quality of life is assessed at baseline and at 6, 12, 18, and 24 months.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 686 patients (343 per treatment arm) will be accrued for this study within 3.8 years.

Conditions
Cervical Cancer
Being tested
conventional surgery, neoadjuvant chemotherapy, brachytherapy, radiation therapy, cisplatin
Keywords
stage IB cervical cancer, stage IIB cervical cancer, stage IIA cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous cell carcinoma
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.

  • conventional surgeryProcedure or surgery

    Radial hysterectomy

  • neoadjuvant chemotherapyProcedure or surgery

    Experimental arm: minimal cumulative cisplatin dose of 225 mg/m2. Comparator arm: cumulative cisplatin dose of 200-240 mg/m2.

  • brachytherapyRadiation

    Brachytherapy at the end of external radiation. Minimal total dose (external with or without external boost + brachytherapy) of 75 Gy EQD2 to point A. Overall treatment less than 50 days.

  • radiation therapyRadiation

    Between 45-50 Gy, in fractions of 1.8 to 2 Gy.

  • cisplatinDrug

    Minimal cumulative 225 mg/m2 (experimental arm). Cumulative 200-240 mg/m2 (comparator arm).

Study groups in NCT00039338
Study groupRoleWhat they receive
Chemotherapy followed by surgeryExperimentalneoadjuvant chemotherapy (Cisplatin) followed by surgery (radial hysterectomy)
Receives: Procedure: conventional surgery; Procedure: neoadjuvant chemotherapy; Drug: cisplatin
Radio-chemotherapyActive comparatorConcomitant radiotherapy (external radiotherapy combined with external boost or brachytherapy) and chemotherapy (cisplatin)
Receives: Procedure: neoadjuvant chemotherapy; Radiation: brachytherapy; Radiation: radiation therapy; Drug: cisplatin

What is being measured

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

  1. Overall survival at 5 years

    Measured: 5 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 2002
  3. Primary completionJul 2019 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
686 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00039338
Sponsor's protocol ID
EORTC-55994
Other IDs
2008-003396-52, 2008
Status last verified
Dec 2016
First submitted
6 Jun 2002
Last updated
5 Dec 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Kenter GG, Greggi S, Vergote I, Katsaros D, Kobierski J, van Doorn H, Landoni F, van der Velden J, Reed N, Coens C, van Luijk I, Colombo N, Steen-Banasik EV, Ottevanger N, Casado A; EORTC-55994 Study Group. Randomized Phase III Study Comparing Neoadjuvant Chemotherapy Followed by Surgery Versus Chemoradiation in Stage IB2-IIB Cervical Cancer: EORTC-55994. J Clin Oncol. 2023 Nov 10;41(32):5035-5043. doi: 10.1200/JCO.22.02852. Epub 2023 Sep 1.

    PubMed 37656948

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing conventional surgery, neoadjuvant chemotherapy and brachytherapy in people with Cervical Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 24 sites in 8 countries.

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

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Netherlands, Italy, Belgium, United Kingdom, Austria and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this 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?

Overall survival at 5 years (time frame: 5 years). 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 NCT00039338, which also lists 1 linked publication.

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 5 Dec 2016.

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