The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer (CQGOG0102)

April 8, 2023 updated by: Dongling Zou, Chongqing University Cancer Hospital

Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer

The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Objective:

    To compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had CCRT alone to those who had adjuvant chemotherapy after CCRT.

  2. Patients:

    1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
    2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%), B点50Gy(+/-10%), concurrent platinum-containing chemotherapy（cisplatin or carboplatin）
    3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
  3. Methods:

The patients who have residual lesions after CCRT are randomized to arm A by observation or arm B by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Recruiting
        • Chongqing Cancer Hospital
        • Principal Investigator:
          • Dongling Zou, M.D.

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
  2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B点50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin))
  3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
  4. ECOG<2
  5. Expected survival is longer than six months
  6. Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L
  7. ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN
  8. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial

Exclusion Criteria:

  1. Activity or uncontrol severe infection
  2. Liver cirrhosis, Decompensated liver disease
  3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
  4. Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure
  5. Have suffered or combined with other malignant tumor
  6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
  7. A history targeted therapy or pelvic artery embolization
  8. Artery-enous thrombosis within 6 months
  9. Patients with autoimmune diseases
  10. Complications, need to be treatment with drugs which may lead to liver or kidney injury
  11. Patients with disease progression after chemoradiation

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
In this group, observation is given after CCRT.
Radiation: CCRT
Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)
Other Names:
  • control group: CCRT + observation
Experimental: trial group
In this group, adjuvant chemotherapy is given after CCRT.
Radiation: CCRT
Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)
Other Names:
  • control group: CCRT + observation
Drug: Paclitaxel, Cisplatin
The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.
Other Names:
  • trial group: CCRT + adjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 2 years
Progression-free survival
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 5 years
5 years overall survival
5 years
ORR
Time Frame: 3 months
To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer
3 months

Collaborators and Investigators

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

Sponsor

Chongqing University Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 26, 2020

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2029

Study Registration Dates

First Submitted

May 23, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 8, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQGOG0102

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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