A Multicenter Trial of Benefits of Adding Post-surgery Chemotherapy for Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2008 by Sun Yat-sen University
Sponsor:
Collaborator:
Guangdong Provincial People's Hospital
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00806117
First received: December 8, 2008
Last updated: August 2, 2011
Last verified: December 2008
  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
Drug: Cisplatin
Drug: Paclitaxel+Cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Trial of Benefits of Adding Chemotherapy as the Adjuvant Post-surgery Therapy for Cervical Cancer With Adverse Pathological Prognostic Factors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • distant metastasis free survival,disease free survival [ Time Frame: 5-Yr ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 5-Yr ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 990
Study Start Date: February 2008
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Radiotherapy
Radiation: Radiotherapy

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: B

Concurrent chemoradiation:

External beam radiation with concurrent weekly platinum chemotherapy

Radiation: Radiotherapy

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)
Drug: Cisplatin
Cisplatin 40mg/m2 every week during external irradiation
Experimental: C

Sequence chemotherapy and radiotherapy:

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

Radiation: Radiotherapy

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)
Drug: Paclitaxel+Cisplatin
Paclitaxel 135~175mg/m2 over 3 hours Cisplatin 60~75mg/m2

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Jihong Liu, Ph.D. Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Jihong Liu, Ph.D. Professor, Sun Yat-sen University Cancer Center
ClinicalTrials.gov Identifier: NCT00806117     History of Changes
Other Study ID Numbers: 2008049
Study First Received: December 8, 2008
Last Updated: August 2, 2011
Health Authority: China: Ministry of Health

Keywords provided by 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
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014