Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer

NCT01363466 | Terminated Phase 3

• 1 other identifier: GYNECO 02/0108
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 35

Brief 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).

Conditions

Stage IB2 Cervical Cancer; Stage II Cervical Cancer; Adenocarcinoma; Squamous Cell Carcinoma; Adenosquamous Carcinoma

Outcome Measures

Primary Outcomes (1)

• Relapse free survival

  There is a follow-up period of 3 years.

  from randomization to relapse or last contact (up to 3 years)

Secondary Outcomes (1)

• Overall Survival

  From randomisation to death or last contact (up to 3 years)

Study Arms (2)

with hysterectomy

EXPERIMENTAL

Procedure: hysterectomy

without hysterectomy

NO INTERVENTION

Interventions

hysterectomy PROCEDURE

with hysterectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Other tumor histology (neuro-endocrine)
• Stage \> II (FIGO 1995) at baseline
• Patient with remaining cervical cancer (after sub-total hysterectomy)

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (35)

Clinique Axium

Aix-en-Provence, 13100, France

Location

Polyclinique du Parc Rambot

Aix-en-Provence, 13100, France

Location

Clinique Sainte Thérèse de l'enfant Jésus

Amiens, 80039, France

Location

Centre Hospitalier Universitaire

Amiens, 80054, France

Location

Centre Paul Papin

Angers, 49033, France

Location

Centre Hospitalier de Beauvais

Beauvais, 60021, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Hospitalier Nord Deux-Sèvres

Bressuire, 79302, France

Location

Centre Hospitalier Universitaire de Brest

Brest, 29609, France

Location

Centre Hospitalier Intercommunal

Créteil, 94010, France

Location

Centre Georges-François Leclerc

Dijon, 21034, France

Location

Centre Hospitalier de Fontainebleau

Fontainebleau, 77305, France

Location

Hôpital Hotel-Dieu

Lyon, 69288, France

Location

Centre Hospitalier Edouard Herriot

Lyon, 69437, France

Location

Centre Hospitalier Lyon Sud

Lyon, 69495, France

Location

Institut paoli Calmettes

Marseille, 13273, France

Location

Centre Hospitalier Régional Universitaire La Timone

Marseille, 13385, France

Location

Hôpital de la conception

Marseille, 13385, France

Location

Centre Hospitalier Régional Universitaire Hôpital Nord

Marseille, 13915, France

Location

Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Centre Val d'Aurelle-Paul Lamarque

Montpellier, 34298, France

Location

Centre hospitalier des Pays de Morlaix

Morlaix, 29205, France

Location

Centre René Gauducheau

Nantes, 44805, France

Location

Hôpital de la Source

Orléans, 45067, France

Location

Hôpital des Diaconnesses

Paris, 75571, France

Location

Hôpital Européen Georges Pompidou

Paris, 75908, France

Location

Centre Hospitalier Universitaire Jean Bernard

Poitiers, 86021, France

Location

Polyclinique de Courlancy

Reims, 51100, France

Location

Clinique Mutualiste de la Sagesse

Rennes, 35013, France

Location

Centre Universitaire Hospitalier- Hôpital Sud

Rennes, 35203, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre René Huguenin

Saint-Cloud, 92210, France

Location

Institut Claudius Régaud

Toulouse, 31052, France

Location

Centre Hospitalier Bretonneau

Tours, 37044, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Adenocarcinoma; Carcinoma, Squamous Cell; Carcinoma, Adenosquamous

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Neoplasms, Complex and Mixed

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Philippe MORICE, Pr

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: June 1, 2011
• Study Start: May 1, 2003
• Study Completion: November 1, 2006
• Last Updated: June 1, 2011

Record last verified: 2011-05

Locations

FR (35)