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

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

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.

Conditions3

Interventions1

Related trials

• Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC) — Changhai Hospital
• Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis — Sixth Affiliated Hospital, Sun Yat-sen University
• Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer — Sun Yat-sen University
• Circulating and Urine Tumor DNA Dynamics Predict Minimal Residual Disease and Recurrence Risk in Locally Advanced Upper Tract Urothelial Carcinoma — RenJi Hospital
• Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial — Larissa University Hospital
• Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers — Sun Yat-sen University
• Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer — Xijing Hospital
• OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes — The Netherlands Cancer Institute

Browse More Trials