Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Docetaxel

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

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

The participants receive no intervention.

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.

Paclitaxel or docetaxel + Cisplatin or carboplatin

Ding Ma, M.D., PhD

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.

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

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

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.

OS is defined as the time from the date of randomization until death of any cause.

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. OS is defined as the time from the date of randomization until death of any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Postoperative Adjuvant Chemotherapy in Early-stage Cervical Cancer That Not Meet Criteria of Adjuvant Therapeutic According to NCCN Guideline	NCT04723875	Uterine Cervica... Cervical Cancer	Paclitaxel or d...	18 Years - 70 Years	Huazhong University of Science and Technology
Postoperative Adjuvant Chemotherapy in Early-stage Cervical Cancer That Not Meet Criteria of Adjuvant Therapeutic According to NCCN Guideline	NCT04723875	Uterine Cervica... Cervical Cancer	Paclitaxel or d...	18 Years - 70 Years	Huazhong University of Science and Technology

Spots Global Cancer Trial Database for paclitaxel or docetaxel + cisplatin or carboplatin