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

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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

December 13, 2012
December 25, 2012
April 28, 2016
January 2011
December 2016   (Final data collection date for primary outcome measure)
disease-free survival [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT01756170 on ClinicalTrials.gov Archive Site
overall survival [ Time Frame: 5 years ]
Same as current
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
Same as current
 
Postoperative Chemoradiation v.s Radiotherapy for Lymph Node Negative Cervical Cancer Patients
Phase III Randomized Trial of Comparing Chemoradiotherapy vs. Radiotherapy Alone in Lymph Node Negative Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Cervical Cancer
  • Drug: paclitaxel
  • Drug: cisplatin
  • Radiation: Radiotherapy
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
Same as current
December 2016
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01756170
WZMC-11352
No
Not Provided
Not Provided
xie congying, Wenzhou Medical University
xie congying
Not Provided
Study Director: Congying Xie, MD the 1st Affiliated Hospital of Wenzhou Medical College
Wenzhou Medical University
April 2016

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