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Postoperative Chemoradiation v.s Radiotherapy for Lymph Node Negative Cervical Cancer Patients

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01756170
Recruitment Status : Unknown
Verified April 2016 by xie congying, Wenzhou Medical University.
Recruitment status was:  Recruiting
First Posted : December 25, 2012
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
xie congying, Wenzhou Medical University

Tracking Information
First Submitted Date  ICMJE December 13, 2012
First Posted Date  ICMJE December 25, 2012
Last Update Posted Date April 28, 2016
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
disease-free survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01756170 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
overall survival [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 19, 2012)
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]
assessed by NCI Common Terminology Criteria v3.0
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Postoperative Chemoradiation v.s Radiotherapy for Lymph Node Negative Cervical Cancer Patients
Official Title  ICMJE Phase III Randomized Trial of Comparing Chemoradiotherapy vs. Radiotherapy Alone in Lymph Node Negative Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy
Brief Summary This phase III study is designed to examine if low-risk (lymph node negative), stage I a2-II b cervical cancer patients treated by paclitaxel/cisplatin chemoradiation have greater toxicities but similar survival rate as those treated by radiotherapy alone.
Detailed Description

Cervical carcinoma is one of the most common gynecologic cancers worldwide. Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with high risk factors cervical cancer. However, the treatment modality in patients with low-risk (lymph node negative) is still disputable. It is not yet known whether cisplatin-based chemoradiotherapy are more effective than radiotherapy alone in treating these patients.

Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemoradiotherapy vs. radiotherapy alone in lymph node negative patients with early-stage cervical cancer following radical hysterectomy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • Drug: paclitaxel
  • Drug: cisplatin
  • Radiation: Radiotherapy
Study Arms  ICMJE
  • Active Comparator: Arm 2
    Patients receive radiotherapy alone as in arm 1.
    Intervention: Radiation: Radiotherapy
  • Experimental: Arm 1
    Patients in this arm will postoperatively receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3 intravenously every 4 weeks with radiation. Radiotherapy consisted of 46-50 gray (5 x 2.0 gray/week) on pelvic area.
    Interventions:
    • Drug: paclitaxel
    • Drug: cisplatin
    • Radiation: Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 19, 2012)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Undertaken radical hysterectomy with diagnosis of invasive cervical cancer (non-small cell type)
  • Negative lymph node
  • At least two risk factors (interstitial infiltration of greater than 1/3, vascular or lymphatic involvement, cervix neoplasms larger than 4 cm, nerve involvement)
  • Eastern Cooperative Oncology Group 0-2
  • Expected life span over 6 months.
  • No distant metastasis
  • Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)
  • Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
  • Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)
  • Written informed consent

Exclusion Criteria:

  • Previous history of chemotherapy or radiation
  • Hypersensitive reaction to platinum/paclitaxel agent
  • History of other cancer
  • Concurrent systemic illness not appropriate for chemotherapy
  • Active infection requiring antibiotics
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01756170
Other Study ID Numbers  ICMJE WZMC-11352
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party xie congying, Wenzhou Medical University
Study Sponsor  ICMJE xie congying
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Congying Xie, MD the 1st Affiliated Hospital of Wenzhou Medical College
PRS Account Wenzhou Medical University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP