Postoperative Adjuvant Chemotherapy in Early-stage Cervical Cancer That Not Meet Criteria of Adjuvant Therapeutic According to NCCN Guideline

NCT04723875 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 2020-S113
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 3

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.

Conditions

Uterine Cervical Neoplasms; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  3 year

Secondary Outcomes (3)

• Overall survival （OS）

  3 year

• 5-year DFS/OS

  5 years

• Incidence of Toxicity

  2 years

Study Arms (2)

Adjuvant chemotherapy group

EXPERIMENTAL

Participant will receive 3 cycles of adjuvant chemotherapy if having any of the following factors；participant will receive 6 cycles of adjuvant chemotherapy if having ≥2 of the following factors. 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 ≥ 2cm

Drug: Paclitaxel or docetaxel + Cisplatin or carboplatin

Control group

NO INTERVENTION

The participants receive no intervention.

Interventions

Paclitaxel or docetaxel + Cisplatin or carboplatin DRUG

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.

Adjuvant chemotherapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with 2018 FIGO staged IB1, IB2, IIA1 cervical cancer.
• 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.
• Postoperative pathological diagnosis was cervical squamous cell carcinoma, cervical adenosquamous cell carcinoma or cervical adenocarcinoma.
• 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.
• Age：18-70 years old.
• 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.
• Eastern Cooperative Oncology Group score 0-1.
• Well-compliance and willing to keep in touch.
• Willing to participate in this study, and sign the informed consent.

You may not qualify if:

• Postoperative pathology has high-risk factors（lymph node metastasis, parametrial infiltration or positive surgical margin）or meets Sedlis criteria.
• Participate in other clinical trials at the same time.
• 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.
• Persons without disposing capacity.
• Drug and/or alcohol abuse.
• Unable or unwilling to sign informed consents.
• Not eligible for the study judged by researchers.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Women's Hospital School Of Medicine Zhejiang University: collaborator
• Qilu Hospital of Shandong University: collaborator
• Obstetrics & Gynecology Hospital of Fudan University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Hunan Cancer Hospital: collaborator
• The Third Xiangya Hospital of Central South University: collaborator

Study Sites (3)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

Qilu Hospital, Shandong University, 107 West Wenhua Road

Ji'nan, Shandong, 250012, China

Location

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Paclitaxel; Docetaxel; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• Ding Ma, M.D., PhD

  Tongji Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: January 28, 2021
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

CN (3)