Clinical trial NCT04723875: Postoperative Adjuvant Chemotherapy in Early-stage Cervical Cancer That Not Meet Criteria of Adjuvant Therapeutic According to NCCN Guideline
Official title: Postoperative Adjuvant Chemotherapy in Early-stage Cervical Cancer That Not Meet Criteria of Adjuvant Therapeutic According to NCCN Guideline: A Prospective Multicenter Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Uterine Cervical Neoplasms
Cervical Cancer
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Women's Hospital School Of Medicine Zhejiang University
name: Qilu Hospital of Shandong University
name: Obstetrics & Gynecology Hospital of Fudan University
name: First Affiliated Hospital of Chongqing Medical University
name: Hunan Cancer Hospital
name: The Third Xiangya Hospital of Central South University
First posted: 2021-01-26
Enrollment: 306
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients who undergo radical surgery but do not meet criteria of adjuvant therapy according to NCCN guideline are enrolled to receive adjuvant chemotherapy. The primary endpoint was disease-free survival (DFS) rate at 3 year. The secondary endpoints were 5-year DFS, overall survival (OS) and safety.


Eligibility criteria: Inclusion Criteria:

1. Patients with 2018 FIGO staged IB1, IB2, IIA1 cervical cancer.
2. The initial treatment was radical hysterectomy + pelvic lymphadenectomy by laparotomy or laparoscopy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.
3. Postoperative pathological diagnosis was cervical squamous cell carcinoma, cervical adenosquamous cell carcinoma or cervical adenocarcinoma.
4. Assessment of risk factors not meeting Sedlis criteria （NCCN guideline），but having one of following factors ：（1）Deep stromal infiltration（≥2/3 layer）；（2）histopathological differentiation grade G2 \~ G3；（3）Lymph-vascular space invasion ；（4）Adenocarcinoma or adenosquamous cell carcinoma；（5）Tumor size ≥2cm.
5. Age：18-70 years old.
6. 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.
7. Eastern Cooperative Oncology Group score 0-1.
8. Well-compliance and willing to keep in touch.
9. Willing to participate in this study, and sign the informed consent.

Exclusion Criteria:

1. Postoperative pathology has high-risk factors（lymph node metastasis, parametrial infiltration or positive surgical margin）or meets Sedlis criteria.
2. Participate in other clinical trials at the same time.
3. Comorbidity including but not limited to: heart diseases (grade III-IV cardiac insufficiency (NYHA standard); central nervous system diseases or nonfunctional behavior; hematological system diseases; liver or kidney malformation or history of surgery.
4. Persons without disposing capacity.
5. Drug and/or alcohol abuse.
6. Unable or unwilling to sign informed consents.
7. Not eligible for the study judged by researchers.

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 3 year
Secondary outcomes:
measure: Overall survival （OS）
timeFrame: 3 year
measure: 5-year DFS/OS
timeFrame: 5 years
measure: Incidence of Toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Ji'nan
country: China
facility: Qilu Hospital, Shandong University, 107 West Wenhua Road
state: Shandong
city: Hangzhou
country: China
facility: Women's Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Tongji Hospital
name: Ding Ma, M.D., PhD
role: STUDY_CHAIR
References: