Randomized Control Trial on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy for the Cervical Cancer
NCT ID: NCT02703961
Last Updated: 2016-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
598 participants
INTERVENTIONAL
2016-02-29
2021-02-28
Brief Summary
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Detailed Description
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Dueñas-González A'［4］ study demonstrated that the 3 year progress free survival and distant metastasis free survival has increased by 8.9% and 8.3% by the radial radiotherapy combined with concurrent chemotherapy with weekly gemcitabine and cisplatin and adjuvant chemotherapy with triweekly gemcitabine and cisplatin. Ryu SY［5］ also reported the triweekly concurrent cisplatin with 3 cycles improved survival outcomes compared with weekly concurrent cisplatin. Retrospective studies by Tang and Jelavić-TB［6-7］ suggested that the adjubant chemotherapy after CCRT has better DMFS and OS.
The aim of present study is to prospectively investigate the efficacy and safety of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for patients with local advanced cervical cancer, especially for those with FIGO III-IVA with or without pelvic lymph node metastasis and the FIGO IB2-IIB with pelvic lymph node metastasis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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experimental
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.
concurrent chemotherapy with cisplatin
in experimental group: cisplatin 60mg/m2, d1,d22;
concurrent chemotherapy with docetaxel
in experimental group: docetaxel 60mg/m2, d1,d22;
pelvic radiotherapy
external beam radiotherapy for whole pelvix with 50Gy/25f boost radiotherapy for pelvic lymph node metastasis with 12-14Gy/4-7f.
brachytherapy
CT/MRI guided brachytherapy or x-ray guided brachytherapy
adjuvant chemotherapy with cisplatin and docetaxel
cisplatin 75mg/m2, d43,d64; docetaxel 75mg/m2, d43,d64
control
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.
concurrent chemotherapy with cisplatin
in experimental group: cisplatin 60mg/m2, d1,d22;
pelvic radiotherapy
external beam radiotherapy for whole pelvix with 50Gy/25f boost radiotherapy for pelvic lymph node metastasis with 12-14Gy/4-7f.
brachytherapy
CT/MRI guided brachytherapy or x-ray guided brachytherapy
Interventions
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concurrent chemotherapy with cisplatin
in experimental group: cisplatin 60mg/m2, d1,d22;
concurrent chemotherapy with docetaxel
in experimental group: docetaxel 60mg/m2, d1,d22;
pelvic radiotherapy
external beam radiotherapy for whole pelvix with 50Gy/25f boost radiotherapy for pelvic lymph node metastasis with 12-14Gy/4-7f.
brachytherapy
CT/MRI guided brachytherapy or x-ray guided brachytherapy
adjuvant chemotherapy with cisplatin and docetaxel
cisplatin 75mg/m2, d43,d64; docetaxel 75mg/m2, d43,d64
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
FEMALE
No
Sponsors
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Air Force Military Medical University, China
OTHER
Responsible Party
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Mei Shi
chair of department
Principal Investigators
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mei shi, professor
Role: PRINCIPAL_INVESTIGATOR
Xijing Hospital, the Fourth Military Medical University
Locations
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Xijing hospital, the Fourth Military Medical University
Xi'an, Shaanxi, China
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi’an, Shanxi, China
Department of Radiation Oncology, Xijing Hospital, Fourth Military
Xi’an, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Tharavichitkul 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.
Gill 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.
Tinkle 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.
Duenas-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.
Ryu 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.
Tang 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.
Other Identifiers
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XJFL-2016-02-LACC-TP triweekly
Identifier Type: -
Identifier Source: org_study_id
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