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

Phase 3

Terminated

• Conditions: Stage IB2 Cervical Cancer; Stage II Cervical Cancer; Adenocarcinoma; Squamous Cell Carcinoma; Adenosquamous Carcinoma

• Registration Number: NCT01363466
• Lead Sponsor: UNICANCER

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study Completion: 2006-11
• Status Verified: 2011-05
• Study First Submitted: 2011-05-05
• Study First Submitted QC: 2011-05-30
• Last Update Submitted: 2011-05-30
• Study First Posted: 2011-06-01
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 61

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Relapse free survival	from randomization to relapse or last contact (up to 3 years)	There is a follow-up period of 3 years.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	From randomisation to death or last contact (up to 3 years)	There is a follow-up period of 3 years.

Trial Locations

Locations (35)

Clinique Axium; 🇫🇷 Aix-en-Provence, France

Polyclinique du Parc Rambot; 🇫🇷 Aix-en-Provence, France

Clinique Sainte Thérèse de l'enfant Jésus; 🇫🇷 Amiens, France

Centre Hospitalier Universitaire; 🇫🇷 Amiens, France

Centre Paul Papin; 🇫🇷 Angers, France

Centre Hospitalier de Beauvais; 🇫🇷 Beauvais, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre Hospitalier Nord Deux-Sèvres; 🇫🇷 Bressuire Cedex, France

Centre Hospitalier Universitaire de Brest; 🇫🇷 Brest, France

Centre Hospitalier Intercommunal; 🇫🇷 Créteil, France

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