Back to resultsClinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery
Primary Purpose
Uterine Cervical Neoplasms, Cervical Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Adjuvant chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Cervical Cancer, NACT, Adjuvant Chemotherapy, Locally Advanced Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter > 4cm before treatment.
- Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma.
- Age：18-70 years old.
- ECOG status score ≤1;
- WBC≥3.5*10^9/L, NEU≥1.5*10^9/L, Platelet≥80×10^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value.
- Well-compliance and willing to keep in touch.
- Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol.
Exclusion Criteria:
- After 2-3 cycles of neoadjuvant chemotherapy, patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.
- Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens.
- Postoperative high risk factors: ① lymph node metastasis, ② parauterine infiltration, ③ positive surgical margin.
- Postoperative risk factors meet the Sedlis standard of the NCCN guideline.
- Participate in other clinical trials.
- Severe diseases of other important systems and organs.
- Persons without disposing capacity.
- Drug and/or alcohol abuse.
- Unable or unwilling to sign informed consents.
- Not eligible for the study judged by researchers.
Sites / Locations
- Tongji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Adjuvant chemotherapy group
Control group
Arm Description
Participant will receive at least 2 cycles of adjuvant chemotherapy. If having any of the following factors, participant will receive additional 2 cycles of adjuvant chemotherapy per risk factor. All patients received maximum 6 cycles of postoperative chemotherapy. Risk factors: (1) Deep cervical invasion（≥ 2/3）；（2）Differentiation grade 2-3；（3）Lymphatic vascular space infiltration；（4）Adenocarcinoma or adenosquamous carcinoma；（5）Tumor size ≥ 4cm before surgery.
The participants receive no intervention.
Outcomes
Primary Outcome Measures
Disease-free survival (DFS)
DFS is defined as the time interval between the date of random assignment and the date of the first documented evidence of relapse at any site or death related to cancer (including toxicity), whichever occurred first.
Secondary Outcome Measures
Overall survival （OS）
OS is defined as the time from the date of randomization until death of any cause.
Quality of Life Outcomes
Patients are asked to complete the questionnaire EORTC QLQ-C30
Quality of Life Outcomes of cervical cancer
Patients are asked to complete the questionnaire EORTC QLQ-CX24
Incidence of Toxicity
The toxicity induced by chemotherapy during observation time will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 5.0.
Full Information
NCT ID
NCT04733820
First Posted
January 21, 2021
Last Updated
January 30, 2021
Sponsor
Huazhong University of Science and Technology
Collaborators
Women's Hospital School Of Medicine Zhejiang University, Qilu Hospital of Shandong University, Obstetrics & Gynecology Hospital of Fudan University, First Affiliated Hospital of Chongqing Medical University, Hunan Cancer Hospital, The Third Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT04733820
Brief Title
Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery
Official Title
Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
February 1, 2028 (Anticipated)
Study Completion Date
February 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
Collaborators
Women's Hospital School Of Medicine Zhejiang University, Qilu Hospital of Shandong University, Obstetrics & Gynecology Hospital of Fudan University, First Affiliated Hospital of Chongqing Medical University, Hunan Cancer Hospital, The Third Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients with FIGO stage IB3, Ⅱ A2 or IIB with tumor size> 4 cm will be enrolled. Patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (NACT) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. Patients meet criteria of adjuvant therapy according to NCCN guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. The primary endpoint was disease-free survival (DFS) rate at 5 year. The secondary endpoints were 5-year overall survival (OS), safety and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms, Cervical Cancer
Keywords
Cervical Cancer, NACT, Adjuvant Chemotherapy, Locally Advanced Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adjuvant chemotherapy group
Arm Type
Experimental
Arm Description
Participant will receive at least 2 cycles of adjuvant chemotherapy. If having any of the following factors, participant will receive additional 2 cycles of adjuvant chemotherapy per risk factor. All patients received maximum 6 cycles of postoperative chemotherapy.
Risk factors: (1) Deep cervical invasion（≥ 2/3）；（2）Differentiation grade 2-3；（3）Lymphatic vascular space infiltration；（4）Adenocarcinoma or adenosquamous carcinoma；（5）Tumor size ≥ 4cm before surgery.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The participants receive no intervention.
Intervention Type
Drug
Intervention Name(s)
Adjuvant chemotherapy
Intervention Description
Drug: Paclitaxel or docetaxel + Cisplatin or carboplatin Paclitaxel 135-175mg/m2 over 3 hours or docetaxel 70-75 mg/m2， 30min ＋ Cisplatin 75-80mg/m2 or carboplatin AUC = 5, repeat per 21 days.
Primary Outcome Measure Information:
Title
Disease-free survival (DFS)
Description
DFS is defined as the time interval between the date of random assignment and the date of the first documented evidence of relapse at any site or death related to cancer (including toxicity), whichever occurred first.
Time Frame
5 year
Secondary Outcome Measure Information:
Title
Overall survival （OS）
Description
OS is defined as the time from the date of randomization until death of any cause.
Time Frame
5 year
Title
Quality of Life Outcomes
Description
Patients are asked to complete the questionnaire EORTC QLQ-C30
Time Frame
5 years
Title
Quality of Life Outcomes of cervical cancer
Description
Patients are asked to complete the questionnaire EORTC QLQ-CX24
Time Frame
5 years
Title
Incidence of Toxicity
Description
The toxicity induced by chemotherapy during observation time will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 5.0.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter > 4cm before treatment.
Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma.
Age：18-70 years old.
ECOG status score ≤1;
WBC≥3.5*10^9/L, NEU≥1.5*10^9/L, Platelet≥80×10^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value.
Well-compliance and willing to keep in touch.
Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol.
Exclusion Criteria:
After 2-3 cycles of neoadjuvant chemotherapy, patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.
Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens.
Postoperative high risk factors: ① lymph node metastasis, ② parauterine infiltration, ③ positive surgical margin.
Postoperative risk factors meet the Sedlis standard of the NCCN guideline.
Participate in other clinical trials.
Severe diseases of other important systems and organs.
Persons without disposing capacity.
Drug and/or alcohol abuse.
Unable or unwilling to sign informed consents.
Not eligible for the study judged by researchers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ding Ma, M.D., PhD
Phone
0086-27-83662681
Email
dma@tjh.tjmu.edu.cn
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ding Ma, M.D., PhD
Phone
0086-27-83662681
Email
dma@tjh.tjmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery
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