Clinical trial NCT04733820: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Uterine Cervical Neoplasms
Cervical Cancer
Keywords: Cervical Cancer
NACT
Adjuvant Chemotherapy
Locally Advanced 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: 2021-02-02
Enrollment: 340
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 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.


Eligibility criteria: 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: ① lymph node metastasis, ② parauterine infiltration, ③ 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.

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 5 year
Secondary outcomes:
measure: Overall survival （OS）
timeFrame: 5 year
measure: Quality of Life Outcomes
timeFrame: 5 years
measure: Quality of Life Outcomes of cervical cancer
timeFrame: 5 years
measure: Incidence of Toxicity
timeFrame: 5 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: