Clinical trial · Interventional
Concurrent Chemoradiotherapy With Weekly Cisplatin Versus Concurrent Chemoradiotherapy With Weekly Cisplatin and Paclitaxel in Locally Advanced Carcinoma Cervix
NCT01593306CI-TRIAL-00006864unknownPhase 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 purpose of this study is to check whether addition of paclitaxel to cisplatin and radiation therapy will improve the outcome in locally advanced carcinoma cervix.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Paclitaxel, Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- cisplatin and paclitaxel with concurrent radiotherapy
- description
- weekly cisplatin at 30mg/m2 and paclitaxel at 50mg/m2 are given with concurrent radiotherapy at 2Gy per fraction at 5 fractions per week for 5 weeks followed by either low dose rate (LDR) Intracavitary (I/C) Brachytherapy or supplement Chemoradiotherapy (CRT); if not fit for I/C Brachytherapy
- interventionNames
- Drug: Paclitaxel, Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- cisplatin with concurrent radiotherapy
- description
- weekly cisplatin @ 40mg/m2 is given along with concurrent radiotherapy at 2Gy per fraction with 5 fractions per week for 5 weeks followed by LDR I/C brachytherapy or supplement CRT; if not fit for I/C Brachytherapy
- interventionNames
- Drug: Cisplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * histologically proven carcinoma cervix * age 18 years to 65 years * stage IIA, IIB, IIIA \& IIIB according to FIGO 2009 Exclusion Criteria: * age \> 65 years and \< 18 years * stage IA, IB, IVA \& IVB * Histology other than squamous cell, adenocarcinoma or adenosquamous carcinoma * history of prior pelvic surgery for cancer, prior pelvic radiotherapy or prior chemotherapy. * deranged renal function test and liver function test * KPS \>= 60 * distant metastasis
References
Publications (1)
- DERIVEDThakur P, Seam R, Gupta M, Gupta M. Prospective randomized study comparing concomitant chemoradiotherapy using weekly cisplatin & paclitaxel versus weekly cisplatin in locally advanced carcinoma cervix. Ann Transl Med. 2016 Feb;4(3):48. doi: 10.3978/j.issn.2305-5839.2015.11.19. PMID 26904570