Clinical trial · Interventional
Randomized Control Trial on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy for the Cervical Cancer
Multicenter Study on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy With Cisplatin and Docetaxel Combined With Radiotherapy for Local Advanced Cervical Cancer
NCT02703961CI-TRIAL-00021408unknownPhase 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 standard treatment of local advanced cervical cancer is concurrent chemoradiotherapy. The 3 year disease free survival was about 50-70%. The distant metastasis is the main cause of failure in local advanced cervical cancer treated with 3-dimensional conformal radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT). The purpose of this study is to investigate the efficacy and tolerance of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for local advanced cervical cancer. It was expected that the 3 year disease free survival would be increased by 10% with this new treatment schedule.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant chemotherapy with cisplatin and docetaxel | Drug | — | UNRESOLVED |
| brachytherapy | Radiation | — | UNRESOLVED |
| concurrent chemotherapy with cisplatin | Drug | — | UNRESOLVED |
| concurrent chemotherapy with docetaxel | Drug | — | UNRESOLVED |
| pelvic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- experimental
- description
- concurrent and adjuvant chemotherapy with cisplatin and docetaxel combined radical radiotherapy. During external beam radiotherapy: cisplatin 60mg/m2, d1,d22; docetaxel 60mg/m2, d1,d22. After external beam radiotherapy: cisplatin 75mg/m2, d43,d64; The patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy. docetaxel 75mg/m2, d43,d64.
- interventionNames
- Drug: concurrent chemotherapy with cisplatin
- Drug: concurrent chemotherapy with docetaxel
- Radiation: pelvic radiotherapy
- Radiation: brachytherapy
- Drug: adjuvant chemotherapy with cisplatin and docetaxel
- type
- OTHER
- label
- control
- description
- standard chemoradiotherapy with weekly cisplatin. Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamouscarcinoma of the cervix 2. FIGO clinical stage IB2-IIB with pelvic lymph node metastasis or FIGO clinical stage III-IVA with or without pelvic lymph node metastasis 3. ECOG performance score 0-1 4. The bone marrow, hepatic and renal function was normal at registration 5. The patients signed informed consent Exclusion Criteria: 1. clear cell and small cell neuroendocrine, sarcoma 2. FIGO stage IVB 3. Prior invasive malignancy 4. Prior systemic chemotherapy 5. Prior radiotherapy to the pelvis or abdomen 6. Severe, active co-morbidity 7. Women who are pregnant 8. immunocompromised status
References
Publications (7)
- BACKGROUNDJelavic TB, Mise BP, Strikic A, Ban M, Vrdoljak E. Adjuvant Chemotherapy in Locally Advanced Cervical Cancer After Treatment with Concomitant Chemoradiotherapy--Room for Improvement? Anticancer Res. 2015 Jul;35(7):4161-5. PMID 26124372
- RESULTTharavichitkul E, Chakrabandhu S, Wanwilairat S, Tippanya D, Nobnop W, Pukanhaphan N, Galalae RM, Chitapanarux I. Intermediate-term results of image-guided brachytherapy and high-technology external beam radiotherapy in cervical cancer: Chiang Mai University experience. Gynecol Oncol. 2013 Jul;130(1):81-5. doi: 10.1016/j.ygyno.2013.04.018. Epub 2013 Apr 17. PMID 23603369
- RESULTGill BS, Kim H, Houser CJ, Kelley JL, Sukumvanich P, Edwards RP, Comerci JT, Olawaiye AB, Huang M, Courtney-Brooks M, Beriwal S. MRI-guided high-dose-rate intracavitary brachytherapy for treatment of cervical cancer: the University of Pittsburgh experience. Int J Radiat Oncol Biol Phys. 2015 Mar 1;91(3):540-7. doi: 10.1016/j.ijrobp.2014.10.053. Epub 2015 Jan 30. PMID 25680598
- RESULTTinkle CL, Weinberg V, Chen LM, Littell R, Cunha JAM, Sethi RA, Chan JK, Hsu IC. Inverse Planned High-Dose-Rate Brachytherapy for Locoregionally Advanced Cervical Cancer: 4-Year Outcomes. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):1093-1100. doi: 10.1016/j.ijrobp.2015.04.018. Epub 2015 Jul 14. PMID 26194683
- RESULTDuenas-Gonzalez A, Zarba JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. doi: 10.1200/JCO.2009.25.9663. Epub 2011 Mar 28. PMID 21444871
- RESULTRyu SY, Lee WM, Kim K, Park SI, Kim BJ, Kim MH, Choi SC, Cho CK, Nam BH, Lee ED. Randomized clinical trial of weekly vs. triweekly cisplatin-based chemotherapy concurrent with radiotherapy in the treatment of locally advanced cervical cancer. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e577-81. doi: 10.1016/j.ijrobp.2011.05.002. Epub 2011 Aug 11.