Stage IB2 Cervical CancerPhase 3NCT01363466
Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
A Phase 3 study testing hysterectomy in people with Stage IB2 Cervical Cancer and Stage II Cervical Cancer, run by UNICANCER at 35 sites in France.
Trial summary
GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional relapse, especially in patient with a reduced metastatic risk and who received a local chemoradiation therapy with an increase of radiotherapy doses (45 grays). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Stage IB2 Cervical Cancer, Stage II Cervical Cancer, Adenocarcinoma
- What is being tested?
- hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 35 sitesFrance
- Study dates
- May 2003to Nov 2006
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- operable Stage IB2/II Cervical Cancer
- adenocarcinoma, squamous cell or adenosquamous carcinoma
- Patient between 18 and 70 years old
- No lombo-aortic lymph node invasion at baseline
- Previous 45 grays external pelvic radiation with concomitant chemotherapy (cisplatin 40 mg/m2/week corresponding to 5 cycles)
- Followed by a 15 grays utero-vaginal brachytherapy, eventually combined with a 6th cycle of chemotherapy (cisplatin 40 mg/m2)
- with a pelvic boost if lymph node or parametrial invasion
- No macroscopic residual tumor after 6 to 8 weeks after brachytherapy.
Who cannot join
- Other tumor histology (neuro-endocrine)
- Stage > II (FIGO 1995) at baseline
- Patient with remaining cervical cancer (after sub-total hysterectomy)
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
France35 sites
Clinique Axium
Aix-en-Provence, 13100
Polyclinique du Parc Rambot
Aix-en-Provence, 13100
Clinique Sainte Thérèse de l'enfant Jésus
Amiens, 80039
Centre Hospitalier Universitaire
Amiens, 80054
Centre Paul Papin
Angers, 49033
Centre Hospitalier de Beauvais
Beauvais, 60021
Institut Bergonié
Bordeaux, 33076
Centre Hospitalier Nord Deux-Sèvres
Bressuire, 79302
Centre Hospitalier Universitaire de Brest
Brest, 29609
Centre Hospitalier Intercommunal
Créteil, 94010
Centre Georges-François Leclerc
Dijon, 21034
Centre Hospitalier de Fontainebleau
Fontainebleau, 77305
Hôpital Hotel-Dieu
Lyon, 69288
Centre Hospitalier Edouard Herriot
Lyon, 69437
Centre Hospitalier Lyon Sud
Lyon, 69495
Institut paoli Calmettes
Marseille, 13273
Centre Hospitalier Régional Universitaire La Timone
Marseille, 13385
Hôpital de la conception
Marseille, 13385
Centre Hospitalier Régional Universitaire Hôpital Nord
Marseille, 13915
Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve
Montpellier, 34295
Centre Val d'Aurelle-Paul Lamarque
Montpellier, 34298
Centre hospitalier des Pays de Morlaix
Morlaix, 29205
Centre René Gauducheau
Nantes, 44805
Hôpital de la Source
Orléans, 45067
Hôpital des Diaconnesses
Paris, 75571
Hôpital Européen Georges Pompidou
Paris, 75908
Centre Hospitalier Universitaire Jean Bernard
Poitiers, 86021
Polyclinique de Courlancy
Reims, 51100
Clinique Mutualiste de la Sagesse
Rennes, 35013
Centre Universitaire Hospitalier- Hôpital Sud
Rennes, 35203
Centre Henri Becquerel
Rouen, 76038
Centre René Huguenin
Saint-Cloud, 92210
Institut Claudius Régaud
Toulouse, 31052
Centre Hospitalier Bretonneau
Tours, 37044
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional relapse, especially in patient with a reduced metastatic risk and who received a local chemoradiation therapy with an increase of radiotherapy doses (45 grays).
- Conditions
- Stage IB2 Cervical Cancer, Stage II Cervical Cancer, Adenocarcinoma, Squamous Cell Carcinoma, Adenosquamous Carcinoma
- Being tested
- hysterectomy
- Medical subject headings
- Uterine Cervical Neoplasms, Adenocarcinoma, Carcinoma, Squamous Cell, Carcinoma, Adenosquamous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysterectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| with hysterectomy | Experimental | Not described Receives: Procedure: hysterectomy |
| without hysterectomy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse free survival
There is a follow-up period of 3 years.
Measured: from randomization to relapse or last contact (up to 3 years)
Secondary outcomes (1)
Overall Survival
There is a follow-up period of 3 years.
Measured: From randomisation to death or last contact (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startMay 2003
- Study completionNov 2006
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IB2 Cervical CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Investigators
- Philippe MORICE, Pr, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363466
- Sponsor's protocol ID
- GYNECO 02/0108
- Status last verified
- May 2011
- First submitted
- 5 May 2011
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
- ClinicalTrials.gov ID
- NCT01363466
- Acronym / sponsor ID
- GYNECO 02/0108
- Conditions
- Stage IB2 Cervical Cancer, Stage II Cervical Cancer, Adenocarcinoma, Squamous Cell Carcinoma, Adenosquamous Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 61 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- May 2003
- Study completion
- Nov 2006 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional relapse, especially in patient with a reduced metastatic risk and who received a local chemoradiation therapy with an increase of radiotherapy doses (45 grays).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with hysterectomy | Experimental | Procedure: hysterectomy |
| without hysterectomy | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- operable Stage IB2/II Cervical Cancer
- adenocarcinoma, squamous cell or adenosquamous carcinoma
- Patient between 18 and 70 years old
- No lombo-aortic lymph node invasion at baseline
- Previous 45 grays external pelvic radiation with concomitant chemotherapy (cisplatin 40 mg/m2/week corresponding to 5 cycles)
Key exclusion criteria (3 listed)
- Other tumor histology (neuro-endocrine)
- Stage > II (FIGO 1995) at baseline
- Patient with remaining cervical cancer (after sub-total hysterectomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hysterectomy | Procedure or surgery | with hysterectomy |
Primary outcome
Relapse free survival
Time frame: from randomization to relapse or last contact (up to 3 years)
There is a follow-up period of 3 years.
1 secondary outcome
Overall Survival
Time frame: From randomisation to death or last contact (up to 3 years)
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe MORICE, Pr principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hysterectomy in people with Stage IB2 Cervical Cancer and Stage II Cervical Cancer, run by UNICANCER at 35 sites in France.
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 8 inclusion and 3 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 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in France. 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?
The study was stopped early (reason given: low recruitment). 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?
Relapse free survival (time frame: from randomization to relapse or last contact (up to 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2011.