Clinical trial · Interventional
Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
NCT01363466CI-TRIAL-00004933terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low recruitment
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Adenosquamous Carcinoma | Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IB2 Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- with hysterectomy
- interventionNames
- Procedure: hysterectomy
- type
- NO_INTERVENTION
- label
- without hysterectomy
Primary outcomes (1)
- measure
- Relapse free survival
- timeFrame
- from randomization to relapse or last contact (up to 3 years)
- description
- There is a follow-up period of 3 years.
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.