Adjuvant chemotherapy for locally advanced cervical cancer patients not meeting NCCN guidelines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 randomized controlled trial investigates the efficacy of adjuvant chemotherapy in patients with locally advanced cervical cancer who do not meet the NCCN guidelines for adjuvant treatment after receiving neoadjuvant chemotherapy and surgery. Eligible patients will undergo 2-3 cycles of neoadjuvant chemotherapy followed by surgery, and those who do not qualify for adjuvant therapy will be randomly assigned to receive either adjuvant chemotherapy or just follow-up visits. The primary endpoint is the disease-free survival rate at five years, with secondary endpoints including overall survival, safety, and quality of life assessments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tongji Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Ding Ma, M.D., PhD
• Email: dma@tjh.tjmu.edu.cn
• Phone: 0086-27-83662681

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cervical screening and care options for women living with HIV who test positive for high-risk HPV

  This study tests different ways to screen and manage high-risk HPV in women with HIV to see what might work best for them.

  Recruiting University of California, San Diego · Nairobi · NCT07925307

• Hydrogel spacer to protect the rectum during cervical cancer radiotherapy

  This study tests whether placing an absorbable hydrogel spacer between the cervix/vagina and rectum before definitive radiotherapy can reduce rectal radiation exposure for women with cervical cancer.

  Recruiting Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07904182

• How cinema sessions during chemotherapy might help cervical cancer patients

  We’re testing if watching films during chemotherapy helps cervical cancer patients feel less anxious and improve quality of life.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07902180

• One-Finger Technique to identify the left upper ureter during para-aortic lymphadenectomy

  This study tests a new surgical method to help surgeons find the left upper ureter during open para-aortic lymphadenectomy in women with gynecologic cancers.

  Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07895212

• Radiotherapy for gynecologic cancer with up to 10 metastatic sites

  This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość · NCT07883798

• Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy

  The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.

  Recruiting The Second People's Hospital of Huai'an · Huai'an, Jiangsu · NCT07860203

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.