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Trial of Postoperative Chemoradiotherapy With or Without Consolidation Chemotherapy for Cervical Cancer Patients

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ClinicalTrials.gov Identifier: NCT01755845
Recruitment Status : Unknown
Verified April 2016 by xie congying, Wenzhou Medical University.
Recruitment status was:  Recruiting
First Posted : December 24, 2012
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
xie congying, Wenzhou Medical University

December 19, 2012
December 24, 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 NCT01755845 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
 
Trial of Postoperative Chemoradiotherapy With or Without Consolidation Chemotherapy for Cervical Cancer Patients
Phase III Randomized Study of Concurrent Paclitaxel/Cisplatin Chemotherapy and Radiotherapy With or Without Consolidation Chemotherapy in High-Risk Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy
The purpose of this study is to determine the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage cervical cancer.

Cervical carcinoma is one of the most common gynecologic cancers worldwide. Early stage cervical cancer can be treated effectively with either radiotherapy or radical hysterectomy plus pelvic lymph node dissection. However, several pathological risk factors, such as lymph node metastasis, the involvement of vaginal resection margin, and the parametrial invasion, have been identified to compromise the patient prognosis.

Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, many patients with pathological risk factors treated with concurrent radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.

Paclitaxel has been demonstrated to be a good radiosensitizer. In addition, paclitaxel/cisplatin combination chemotherapy was demonstrated to have superior progression-free survival than platinum alone in some phase Ⅱ studies. In addition, it is not yet known whether chemotherapy and radiation therapy are more effective when given with consolidation chemotherapy in treating cervical cancer.

Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemotherapy and radiotherapy with consolidation chemotherapy in high-risk 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
  • 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. After completion of chemoradiotherapy, patients receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: paclitaxel
    • Drug: cisplatin
    • Radiation: radiotherapy
  • Active Comparator: Arm 2
    Patients receive chemoradiotherapy as in arm 1.
    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
300
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 I a2-II b (non-small cell type)
  • One or more risk factors (lymph node involvement, resection margin involvement, parametrial 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
  • Metastasis to paraaortic lymph node
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
 
 
NCT01755845
WZMC-11256
Yes
Not Provided
Not Provided
xie congying, Wenzhou Medical University
xie congying
Not Provided
Not Provided
Wenzhou Medical University
April 2016

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