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

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CCRT
Paclitaxel, Cisplatin
Sponsored by
Chongqing University Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Locally adcanced, CCRT, Adjuvant chemotherapy

Eligibility Criteria

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

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

Sites / Locations

  • Chongqing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

trial group

Arm Description

In this group, observation is given after CCRT.

In this group, adjuvant chemotherapy is given after CCRT.

Outcomes

Primary Outcome Measures

PFS
Progression-free survival

Secondary Outcome Measures

OS
5 years overall survival
ORR
To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer

Full Information

First Posted
May 23, 2020
Last Updated
April 8, 2023
Sponsor
Chongqing University Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04409860
Brief Title
The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer
Acronym
CQGOG0102
Official Title
Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing University Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Locally adcanced, CCRT, Adjuvant chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
In this group, observation is given after CCRT.
Arm Title
trial group
Arm Type
Experimental
Arm Description
In this group, adjuvant chemotherapy is given after CCRT.
Intervention Type
Radiation
Intervention Name(s)
CCRT
Other Intervention Name(s)
control group: CCRT + observation
Intervention Description
Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel, Cisplatin
Other Intervention Name(s)
trial group: CCRT + adjuvant chemotherapy
Intervention Description
The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.
Primary Outcome Measure Information:
Title
PFS
Description
Progression-free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
OS
Description
5 years overall survival
Time Frame
5 years
Title
ORR
Description
To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma Complete CCRT(Radiation Does: A point 85Gy(+/-10%),B点50Gy(+/-10%),concurrent platinum-containing chemotherapy (cisplatin or carboplatin)) MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm). ECOG<2 Expected survival is longer than six months Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN 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: Activity or uncontrol severe infection Liver cirrhosis, Decompensated liver disease History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure Have suffered or combined with other malignant tumor Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure A history targeted therapy or pelvic artery embolization Artery-enous thrombosis within 6 months Patients with autoimmune diseases Complications, need to be treatment with drugs which may lead to liver or kidney injury Patients with disease progression after chemoradiation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongling Zou, M.D.
Phone
13657690699
Email
cqzl_zdl@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongling Zou, M.D.
Organizational Affiliation
Chongqing University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongling Zou, M.D.
Phone
13657690699
Email
cqzl_zdl@163.com
First Name & Middle Initial & Last Name & Degree
Dongling Zou, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
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The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

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