Actively Recruiting
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
Led by Huazhong University of Science and Technology · Updated on 2021-02-02
340
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
H
Huazhong University of Science and Technology
Lead Sponsor
W
Women's Hospital School Of Medicine Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical stage IB3 to IIB cervical cancer with tumor diameter greater than 4 cm before treatment
- Pathologically confirmed cervical cancer including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- Age between 18 and 70 years
- ECOG performance status score of 1 or less
- Adequate blood counts and liver and kidney function within specified limits
- Willing and able to comply with study requirements and maintain contact
- Able to provide informed consent and follow study instructions
You will not qualify if you...
- Patients who did not undergo laparotomic or laparoscopic extensive hysterectomy with pelvic lymph node dissection after 2-3 cycles of neoadjuvant chemotherapy
- Neoadjuvant chemotherapy regimens different from the postoperative adjuvant therapy regimens
- Presence of postoperative high-risk factors such as lymph node metastasis, parauterine infiltration, or positive surgical margin
- Postoperative risk factors meeting the Sedlis criteria according to NCCN guidelines
- Participation in other clinical trials
- Severe diseases affecting important organs or systems
- Lack of legal capacity to consent
- Drug or alcohol abuse
- Unable or unwilling to sign informed consent
- Judged ineligible for the study by researchers
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Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
D
Ding Ma, M.D., PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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