Clinical trial · Interventional
Study on Early Stage Bulky Cervical Cancers
Randomised Phase III Clinical Trial on Concurent Chemoradiation vs. Neoadjuvant Chemoradiation and Surgery vs. Neoadjuvant Chemotherapy and Surgery in Early Stage Bulky Cervical Cancers (FIGO Stages IB2, IIA2 and IIB)
NCT01917695CI-TRIAL-00018818unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to establish the role of neoadjuvant chemotherapy and chemo irradiation in carcinoma cervix and to compare its results with the concurrent chemo irradiation in terms of overall survival, disease free survival and quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma Cervix | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Radiation | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| External Beam Radiotherapy | Radiation | — | UNRESOLVED |
| Radical Hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Concurrent Radical Chemoradiation
- description
- Paclitaxel(175 mg/sq.m) + Cisplatin (75 mg/sq.m) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT + Brachytherapy (7Gy HDR x 3 doses) All to be completed within 8-10 weeks
- interventionNames
- Drug: Chemotherapy
- Radiation: External Beam Radiotherapy
- Radiation: Brachytherapy
- type
- EXPERIMENTAL
- label
- Neoadjuvant Chemoradiation + Radical Hysterectomy
- description
- Paclitaxel(175 mg/m2) + Cisplatin(75 mg/m2) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT - completed within 5 weeks Radical Hysterectomy - 3 weeks after completion of RT All to be completed within 8-10 weeks
- interventionNames
- Drug: Chemotherapy
- Radiation: External Beam Radiotherapy
- Procedure: Radical Hysterectomy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically confirmed bulky cervical Squamous cell carcinoma (FIGO stage IB2, II A2, IIB). 2. Age 18-60 years 3. Karnofsky performance status of ≥70%; ECOG PS ≤ 2 Exclusion Criteria: 1. Nonsquamous Histologies 2. Other systemic diseases, comorbidities precluding full participation in the study 3. Concomitant treatment with any experimental drug 4. Pregnant or nursing women 5. Previous or concomitant malignant diseases other than non-melanoma skin cancer 6. Previous radiation to the pelvis
References
Publications (0)
Data not yet available
No reference posted for this study.