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Comparison of Post-surgery Adjuvant Therapy for Cervical Carcinoma

This study is currently recruiting participants.
Verified March 2016 by Jihong Liu, Sun Yat-sen University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00806117
First Posted: December 10, 2008
Last Update Posted: March 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Guangdong Provincial People's Hospital
First Affiliated Hospital, Sun Yat-Sen University
Shenzhen People's Hospital
Cancer Hospital of Guangxi Medical University
Information provided by (Responsible Party):
Jihong Liu, Sun Yat-sen University
  Purpose

Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of the survival over years. The risk of recurrence after radical surgery has increased with positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep invasion of the cervical stroma. In recent years, the role of chemotherapy for cervical cancer has been gradually recognized. But as a adjuvant therapy post-surgery, if chemotherapy can improve the overall survival rate of patients with adverse pathological prognostic factors is inconclusive.

In this study, in order to investigate the effect and adverse reaction of chemotherapy as the adjuvant therapy post-surgery on patients with adverse pathological prognostic factors, nine hundred and ninety patients will be randomly divided into three groups, comparing radiotherapy alone, concurrent chemoradiation and sequence chemotherapy and radiotherapy (2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation). The investigators aim to find out the best therapeutic regimen with lowest adverse reaction for cervical cancer with adverse pathological prognostic factors. To guide clinical treatment options.


Condition Intervention Phase
Cervical Cancer Radiation: Radiotherapy (RT) Other: Concurrent chemoirradiation (CCRT) Other: Sequence chemotherapy and radiotherapy (SCRT) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Different Adjuvant Treatments Following Radical Surgery in Early Stage Cervical Carcinoma

Resource links provided by NLM:


Further study details as provided by Jihong Liu, Sun Yat-sen University:

Primary Outcome Measures:
  • Disease Free Survival [ Time Frame: 3-Yr ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 5-Yr ]

Estimated Enrollment: 990
Study Start Date: February 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiotherapy (RT)
Radiotherapy
Radiation: Radiotherapy (RT)

External irradiation 50Gy/5 weeks

  • Lateral: 2 cm lateral to the bony margin of the pelvis
  • Superior: Between L5 and S1
  • Inferior: 2 cm below the obturator foramen Intracavitary boost 30-35Gy/4 weeks(positive vaginal margins only)
Experimental: Concurrent chemoirradiation (CCRT)

Concurrent chemoirradiation:

External beam radiation with concurrent weekly platinum chemotherapy

Other: Concurrent chemoirradiation (CCRT)
Cisplatin 40mg/m2 every week during external irradiation
Experimental: Sequence chemo and radiation (SCRT)

Sequence chemotherapy and radiotherapy:

2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation

Other: Sequence chemotherapy and radiotherapy (SCRT)
Paclitaxel 135~175mg/m2 over 3 hours Cisplatin 60~75mg/m2

Detailed Description:

After radical surgery, patients with stage IB1 to IIA2 cervical cancer who had one or more following pathological factors were recruited: lymph node metastases (LNM), positive parametrium or margins (PPM), lymphatic vascular space involvement (LVSI), deep invasion of cervical stromal (DIS). Eligible patients were randomized to three groups. Group A underwent 50 GY RT alone. Group B received concurrent weekly cisplatin and RT. Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles.

We have recruited 800 patients till November 2014.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly histologically confirmed cervical carcinoma
  • Original clinical stage must be Ib~IIa (FIGO)
  • Age between 18-65
  • With the presence of these four factors after radical surgery:(1)positive lymph nodes,(2)positive parametria, or positive surgical margins,(3)positive lymphatic vascular space,(4)outer one-third invasion of the cervical stroma
  • More than 3 months survival is to expect
  • Patients must give signed informed consent

Exclusion Criteria:

  • The presence of uncontrolled life-threatening illness
  • Receiving other ways of anti-cancer therapy
  • Residual tumor which can not be removed in the surgery
  • Investigator consider the patients can't finish the whole study
  • With normal liver function test (ALT、AST>2.5×ULN)
  • With normal renal function test (Creatinine>1.5×ULN)
  • WBC<4,000/mm3 or PLT<100,000/mm3
  • Receive the external pelvic irradiation before the surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806117


Contacts
Contact: Jihong Liu, Ph.D. 86-20-8734-3102 Liujih@mail.sysu.edu.cn
Contact: He Huang, Ph.D. 86-20-8734-3104 huangh@sysucc.org.cn

Locations
China, Guangdong
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jihong Liu, Ph.D.    86-20-87343102    Liujih@mail.sysu.edu.cn   
Contact: He Huang, Ph.D.    86-20-87343104    huangh@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Guangdong Provincial People's Hospital
First Affiliated Hospital, Sun Yat-Sen University
Shenzhen People's Hospital
Cancer Hospital of Guangxi Medical University
Investigators
Study Chair: Jihong Liu, Ph.D. Sun Yat-sen University
  More Information

Responsible Party: Jihong Liu, Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00806117     History of Changes
Other Study ID Numbers: SYSU50102008049
First Submitted: December 8, 2008
First Posted: December 10, 2008
Last Update Posted: March 15, 2016
Last Verified: March 2016

Keywords provided by Jihong Liu, Sun Yat-sen University:
Cervical cancer
Concurrent chemoradiation
Randomized controlled clinical trials

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Antineoplastic Agents