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

March 15, 2016 updated by: Mei Shi, Air Force Military Medical University, China

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

598

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi' An, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital, the Fourth Military Medical University
        • Contact:
        • Contact:
    • Shanxi
      • Xi'an, Shanxi, China, 710032
        • Recruiting
        • Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
        • Contact:
        • Principal Investigator:
          • Mei Shi, MM
      • Xi'an, Shanxi, China, 710032
        • Recruiting
        • Department of Radiation Oncology, Xijing Hospital, Fourth Military
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: concurrent chemotherapy with cisplatin
in experimental group: cisplatin 60mg/m2, d1,d22;
Other Names:
  • cisplatin
Drug: concurrent chemotherapy with docetaxel
in experimental group: docetaxel 60mg/m2, d1,d22;
Other Names:
  • docetaxel
Radiation: pelvic radiotherapy
external beam radiotherapy for whole pelvix with 50Gy/25f boost radiotherapy for pelvic lymph node metastasis with 12-14Gy/4-7f.
Other Names:
  • external beam radiotherapy
Radiation: 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
OTHER: 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.
Drug: concurrent chemotherapy with cisplatin
in experimental group: cisplatin 60mg/m2, d1,d22;
Other Names:
  • cisplatin
Radiation: pelvic radiotherapy
external beam radiotherapy for whole pelvix with 50Gy/25f boost radiotherapy for pelvic lymph node metastasis with 12-14Gy/4-7f.
Other Names:
  • external beam radiotherapy
Radiation: brachytherapy
CT/MRI guided brachytherapy or x-ray guided brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease free survival
Time Frame: 3 year
3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3 year
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Investigators

  • Principal Investigator: mei shi, professor, Xijing Hospital, the Fourth Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ANTICIPATED)

February 1, 2018

Study Completion (ANTICIPATED)

February 1, 2021

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (ESTIMATE)

March 9, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJFL-2016-02-LACC-TP triweekly

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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