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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04733820
• Other study ID #: 2020-S111
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2021
• Est. completion date: February 1, 2028

Study information

• Verified date: January 2021
• Source: Huazhong University of Science and Technology
• Contact: Ding Ma, M.D., PhD
• Phone: 0086-27-83662681
• Email: dma[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: February 1, 2028
• Est. primary completion date: February 1, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter > 4cm before treatment.

2. Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma.

3. Age:18-70 years old.

4. ECOG status score =1;

5. 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.

6. Well-compliance and willing to keep in touch.

7. Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol.

Exclusion Criteria:

1. 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.

2. Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens.

3. Postoperative high risk factors: ? lymph node metastasis, ? parauterine infiltration, ? positive surgical margin.

4. Postoperative risk factors meet the Sedlis standard of the NCCN guideline.

5. Participate in other clinical trials.

6. Severe diseases of other important systems and organs.

7. Persons without disposing capacity.

8. Drug and/or alcohol abuse.

9. Unable or unwilling to sign informed consents.

10. Not eligible for the study judged by researchers.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Adjuvant chemotherapy
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.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (7)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	First Affiliated Hospital of Chongqing Medical University, Hunan Cancer Hospital, Obstetrics & Gynecology Hospital of Fudan University, Qilu Hospital of Shandong University, The Third Xiangya Hospital of Central South University, Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 year
Secondary	Overall survival (OS)	OS is defined as the time from the date of randomization until death of any cause.	5 year
Secondary	Quality of Life Outcomes	Patients are asked to complete the questionnaire EORTC QLQ-C30	5 years
Secondary	Quality of Life Outcomes of cervical cancer	Patients are asked to complete the questionnaire EORTC QLQ-CX24	5 years
Secondary	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.	5 years