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
1 other identifier
interventional
598
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2016
Longer than P75 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 3, 2016
CompletedFirst Posted
Study publicly available on registry
March 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedMarch 17, 2016
March 1, 2016
2 years
March 3, 2016
March 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease free survival
3 year
Secondary Outcomes (1)
overall survival
3 year
Study Arms (2)
experimental
EXPERIMENTALconcurrent 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.
control
OTHERstandard 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.
Interventions
in experimental group: cisplatin 60mg/m2, d1,d22;
in experimental group: docetaxel 60mg/m2, d1,d22;
external beam radiotherapy for whole pelvix with 50Gy/25f boost radiotherapy for pelvic lymph node metastasis with 12-14Gy/4-7f.
cisplatin 75mg/m2, d43,d64; docetaxel 75mg/m2, d43,d64
Eligibility Criteria
You may qualify if:
- Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamouscarcinoma of the cervix
- FIGO clinical stage IB2-IIB with pelvic lymph node metastasis or FIGO clinical stage III-IVA with or without pelvic lymph node metastasis
- ECOG performance score 0-1
- The bone marrow, hepatic and renal function was normal at registration
- The patients signed informed consent
You may not qualify if:
- clear cell and small cell neuroendocrine, sarcoma
- FIGO stage IVB
- Prior invasive malignancy
- Prior systemic chemotherapy
- Prior radiotherapy to the pelvis or abdomen
- Severe, active co-morbidity
- Women who are pregnant
- immunocompromised status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Xijing hospital, the Fourth Military Medical University
Xi'an, Shaanxi, 710032, China
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi’an, Shanxi, 710032, China
Department of Radiation Oncology, Xijing Hospital, Fourth Military
Xi’an, Shanxi, 710032, China
Related Publications (7)
Jelavic 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: 26124372BACKGROUNDTharavichitkul 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: 23603369RESULTGill 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: 25680598RESULTTinkle 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: 26194683RESULTDuenas-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: 21444871RESULTRyu 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.
PMID: 21840137RESULTTang J, Tang Y, Yang J, Huang S. Chemoradiation and adjuvant chemotherapy in advanced cervical adenocarcinoma. Gynecol Oncol. 2012 May;125(2):297-302. doi: 10.1016/j.ygyno.2012.01.033. Epub 2012 Jan 31.
PMID: 22307061RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
mei shi, professor
Xijing Hospital, the Fourth Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chair of department
Study Record Dates
First Submitted
March 3, 2016
First Posted
March 9, 2016
Study Start
February 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2021
Last Updated
March 17, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will share