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

Last updated: October 30, 2024
Sponsor: Huazhong University of Science and Technology
Overall Status: Active - Not Recruiting

Phase

3

Condition

Cervical Cancer

Dysfunctional Uterine Bleeding

Vaginal Cancer

Treatment

Paclitaxel or docetaxel + Cisplatin or carboplatin

Clinical Study ID

NCT04723875
2020-S113
  • Ages 18-70
  • Female

Study 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

Inclusion Criteria:

  1. Patients with 2018 FIGO staged IB1, IB2, IIA1 cervical cancer.

  2. The initial treatment was radical hysterectomy + pelvic lymphadenectomy bylaparotomy or laparoscopy with cervical cancer foci sealed before dissection of thevagina and without uterine manipulator.

  3. Postoperative pathological diagnosis was cervical squamous cell carcinoma, cervicaladenosquamous cell carcinoma or cervical adenocarcinoma.

  4. Assessment of risk factors not meeting Sedlis criteria (NCCN guideline),but havingone of following factors :(1)Deep stromal infiltration(≥2/3layer);(2)histopathological differentiation grade G2 ~ G3;(3)Lymph-vascular spaceinvasion ;(4)Adenocarcinoma or adenosquamous cell carcinoma;(5)Tumor size ≥2cm.

  5. Age:18-70 years old.

  6. WBC≥3.510^9/L, NEU≥1.510^9/L, Platelet≥80×10^9 /L; AST and ALT ≤1.5 times normalupper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serumcreatinine 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

Exclusion Criteria:

  1. Postoperative pathology has high-risk factors(lymph node metastasis, parametrialinfiltration 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 cardiacinsufficiency (NYHA standard); central nervous system diseases or nonfunctionalbehavior; hematological system diseases; liver or kidney malformation or history ofsurgery.

  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.

Study Design

Total Participants: 306
Treatment Group(s): 1
Primary Treatment: Paclitaxel or docetaxel + Cisplatin or carboplatin
Phase: 3
Study Start date:
January 28, 2021
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Tongji Hospital

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Qilu Hospital, Shandong University, 107 West Wenhua Road

    Ji'nan, Shandong 250012
    China

    Site Not Available

  • Women's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.