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

This study is currently recruiting participants.
Verified April 2016 by xie congying, Wenzhou Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01755845
First Posted: December 24, 2012
Last Update Posted: April 28, 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.
Information provided by (Responsible Party):
xie congying, Wenzhou Medical University
  Purpose
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.

Condition Intervention Phase
Cervical Cancer Drug: paclitaxel Drug: cisplatin Radiation: radiotherapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by xie congying, Wenzhou Medical University:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 5 years ]

Other Outcome Measures:
  • 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


Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: paclitaxel Drug: cisplatin Radiation: radiotherapy
Active Comparator: Arm 2
Patients receive chemoradiotherapy as in arm 1.
Drug: paclitaxel Drug: cisplatin Radiation: radiotherapy

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT01755845


Contacts
Contact: congying xie, MD +86-577-88069316 wzxiecongying@163.com

Locations
China, Zhejiang
The First Affiliated Hospital of Wenzhou Medical College Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: congying xie    +86-577-88069316    wzxiecongying@163.com   
Principal Investigator: congying xie, MD         
Sponsors and Collaborators
xie congying
  More Information

Responsible Party: xie congying, Director, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01755845     History of Changes
Other Study ID Numbers: WZMC-11256
First Submitted: December 19, 2012
First Posted: December 24, 2012
Last Update Posted: April 28, 2016
Last Verified: April 2016

Keywords provided by xie congying, Wenzhou Medical University:
cervical cancer
radiotherapy
postoperative therapy
chemotherapy

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
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action