A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pelvic or Para-aortic Node Involvement)

March 22, 2018 updated by: Wei-jun Ye, Sun Yat-sen University

Adjuvant Chemotherapy Versus Observation After Radiation With Concurrent Cisplatin of Cervical Cancer (With Pelvic or Para-aortic Node Involvement) :A Phase 3 Prospective Multi-institutional Randomised Controlled Trial

Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events and local recurrence rate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Background Cervical Cancer is one of the most common malignant tumors of Chinese females. Women with evidence of para-aortic node involvement have a poor prognosis with a five-year survival rate of approximately 40 percent. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. It is not clear whether systemic chemotherapy delivered following RT will obtain survival benefit.
  2. Objective The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events, 3y-PFS and 5y-OS, .
  3. Patients

A patient will be enrolled when patient have:

  1. Pathologically diagnosed cervical cancer;

  2. pelvic or para-aortic lymph metastases, at least match one of following

    • CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane
    • pelvic or para-aortic lymph node shows necrosis or extra capsular spread
    • PET/CT scan finds positive pelvic or para-aortic node lymph node
    • biopsy confirms lymph metastase
  3. Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;
  4. Karnofsky Performance Scores ≥ 70;

4.Method

  1. Randomization is performed to divide the patients into the control group (Group A) and the experimental group (Group B). In Group A, observation is given after radiation with concurrent cisplatin. But in Group B, three cycles of adjuvant chemotherapy ( Paclitaxel plus Cisplatin) are administered after radiation with concurrent cisplatin. The regimen of adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks.The Grade 3/4 adverse events (CTCAE criteria ver. 4.03), the 3-year progression-free survival of the 2 groups, the 5-year overall survival of the 2 groups are compared.
  2. In Group A and Group B, both the radiation method and the regimen of concurrent chemotherapy are the same.The gross tumor volume (GTVnd) is the lymph node lesion and given a dose of 60Gy. The clinical target volume (CTV) is according to the lymph drainage pathway and given a dose of 45Gy. The regimen of concurrent chemotherapy is Cisplatin 80mg/m2 once three weeks.

Study Type

Interventional

Enrollment (Anticipated)

432

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Foshan, Guangdong, China
        • Not yet recruiting
        • Sun Yat-sen University Affiliated Foshan Hospital
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
        • Contact:
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Hospital of of Guangdong Armed Police Corps
        • Contact:
          • Zhen-lun Li, M.D
          • Phone Number: 86-13580516205
          • Email: sfqiu@126.com
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
        • Contact:
      • Guanzhou, Guangdong, China
        • Not yet recruiting
        • Guangzhou First People's Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • Not yet recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
    • Hainan
      • Haikou, Hainan, China
        • Not yet recruiting
        • Hainan General Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • Not yet recruiting
        • Xinjiang Medical University Affiliated Tumor Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Pathologically diagnosed cervical cancer;

  2. pelvic or para-aortic lymph metastases, at least match one of following

    • CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane
    • pelvic or para-aortic lymph node shows necrosis or extra capsular spread
    • PET/CT scan finds positive pelvic or para-aortic node lymph node
    • biopsy confirms lymph metastase
  3. Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;
  4. Karnofsky Performance Scores ≥ 70;

Exclusion Criteria:

  1. Patients with distant metastasis before or during radiotherapy
  2. Severe dysfunction of heart, lung, liver, kidney or hematopoietic system
  3. Severe neurological, mental or endocrine diseases
  4. History of other malignancies
  5. Those who are considered by the researchers unsuitable to participate -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: The control group (Group A)
In Group A, observation is given after chemoradiation
Radiation: chemoradiation
radiation with concurrent ciplatin
EXPERIMENTAL: The experiment group (Group B)
in Group B, three cycles of Paclitaxel, Cisplatin are administered after radiation with concurrent cisplatin. The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks.
Radiation: chemoradiation
radiation with concurrent ciplatin
Drug: Paclitaxel, Cisplatin
The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel, Cisplatin once 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year progression-free survival (3y-PFS)
Time Frame: 3 years after the date of adjuvant chemotherapy completion
Percentage of patients in a treatment group who are alive without disease get worse for a 3-year period of follow-up after the date of adjuvant chemotherapy completion
3 years after the date of adjuvant chemotherapy completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of grade 3/4 adverse event
Time Frame: Once a week during therapy, up to 5 years after the date of adjuvant chemotherapy completion
Incidence of patients in a treatment group who manifest a specific adverse event (such as myelosuppression) of grade 3/4. Incidence is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) criteria ver. 4.03.
Once a week during therapy, up to 5 years after the date of adjuvant chemotherapy completion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year overall survival (5y-OS)
Time Frame: 5 years after the date of adjuvant chemotherapy completion
Percentage of patients in a treatment group who are alive for a 5-year period of follow-up after the date of adjuvant chemotherapy completion
5 years after the date of adjuvant chemotherapy completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Wei-jun Ye, M.D, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ANTICIPATED)

March 1, 2025

Study Completion (ANTICIPATED)

March 1, 2025

Study Registration Dates

First Submitted

March 10, 2018

First Submitted That Met QC Criteria

March 15, 2018

First Posted (ACTUAL)

March 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2018

Last Update Submitted That Met QC Criteria

March 22, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2017-105-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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