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

Primary Purpose

Cervical Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

paclitaxel

cisplatin

Radiotherapy

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring cervical cancer, radiotherapy, postoperative therapy, chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

The First Affiliated Hospital of Wenzhou Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 2

Arm 1

Arm Description

Patients receive radiotherapy alone as in 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.

Outcomes

Primary Outcome Measures

disease-free survival

Secondary Outcome Measures

overall survival

Full Information

NCT ID

NCT01756170

First Posted

December 13, 2012

Last Updated

April 27, 2016

Sponsor

xie congying

1. Study Identification

Unique Protocol Identification Number

NCT01756170

Brief Title

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

Official Title

Phase III Randomized Trial of Comparing Chemoradiotherapy vs. Radiotherapy Alone in Lymph Node Negative Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

xie congying

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

cervical cancer, radiotherapy, postoperative therapy, chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Description

Patients receive radiotherapy alone as in arm 1.

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

paclitaxel

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Primary Outcome Measure Information:

Title

disease-free survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

Number of participants with adverse events as a measure of safety and tolerability

Description

assessed by NCI Common Terminology Criteria v3.0

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

congying xie, MD

Phone

+86-577-88069316

wzxiecongying@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Congying Xie, MD

Organizational Affiliation

the 1st Affiliated Hospital of Wenzhou Medical College

Official's Role

Study Director

Facility Information:

Facility Name

The First Affiliated Hospital of Wenzhou Medical College

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

congying xie, MD

Phone

+86-577-88069316

wzxiecongying@163.com

First Name & Middle Initial & Last Name & Degree

congying xie, MD

12. IPD Sharing Statement

Learn more about this trial

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

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