Randomized Control Trial on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy for the Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Multicenter Study on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy With Cisplatin and Docetaxel Combined With Radiotherapy for Local Advanced Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02703961
• Other study ID #: XJFL-2016-02-LACC-TP triweekly
• Status: Recruiting
• Phase: Phase 3
• First received: March 3, 2016
• Last updated: March 15, 2016
• Start date: February 2016
• Est. completion date: February 2021

Study information

• Verified date: March 2016
• Source: Fourth Military Medical University
• Contact: mei shi, professor
• Phone: 0086-029-84775432
• Email: mshi82[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The cervical cancer is the most common malignant gynecological tumor in the developing area. From 1999, the concurrent chemoradiotherapy has been established as the standard treatment for local advanced cervical cancer. The modern radiotherapy techniques, such as 3 dimensional conformal radiotherapy(3D-CRT), intensity modulated radiotherapy(IMRT), image guided 3-dimensional brachytherapy(3D-BT), was widely used for the treatment of cervical cancer. The recently clinical outcome showed that the 3 year local and regional control was more than 90%［1-3］. The distant metastasis has proved to be the main cause of failure and death, especially for the patient with pelvic lymph node metastasis, large volume of tumor and advanced FIGO stage. the data showed that the 3 year distant metastasis free survival and overall survival were 64.7% and 64.6% respectively for the patient with huge pelvic lymph node metastasis and FIGO stage III- IVA. The system treatment pointing at the distant metastasis has become to be the topic of clinical investigation.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 598
• Est. completion date: February 2021
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• concurrent chemotherapy with cisplatin
in experimental group: cisplatin 60mg/m2, d1,d22;
• concurrent chemotherapy with docetaxel
in experimental group: docetaxel 60mg/m2, d1,d22;

Radiation:
• 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

Drug:
• adjuvant chemotherapy with cisplatin and docetaxel
cisplatin 75mg/m2, d43,d64; docetaxel 75mg/m2, d43,d64

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Xijing Hospital, Fourth Military	Xi'an	Shanxi
China	Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University	Xi'an	Shanxi
China	Xijing hospital, the Fourth Military Medical University	Xi` An	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (7)

Dueñas-González A, Zarbá 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 adju — View Citation

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 experienc — View Citation

Jelavic TB, Miše 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. — View Citation

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 — View Citation

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. — View Citation

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 Univers — View Citation

Tinkle CL, Weinberg V, Chen LM, Littell R, Cunha JA, 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):1093-100. doi: 10.101 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival		3 year	Yes
Secondary	overall survival		3 year	Yes