Evaluating surgery for cervical cancer patients with remaining tumors after treatment

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 study investigates the effectiveness of salvage surgery in patients diagnosed with locally advanced cervical cancer who still have residual tumors following concurrent chemoradiation. It is a single-center, single-arm study focusing on patients with specific FIGO stages of cervical cancer. The study aims to assess surgical outcomes after patients have undergone standard chemoradiotherapy and have been evaluated by a multidisciplinary team. The primary goal is to determine if surgical intervention can improve patient outcomes in this challenging clinical scenario.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Stage Ib3 and IIA2-IVA (FIGO2018) cervical cancer with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma.
2. Complete standard CCRT(Pelvic EBRT+ concurrent platinum-containing chemotherapy+ brachytherapy).
3. After 4-12 weeks of treatment, the cervical biopsy pathology confirmed residual cancer, or the cervical biopsy was negative, but PET /CT showed that SUVmax of the residual lesions in the cervical and/or pelvic lymph nodes were ≥ 2.5, two or more gynaecological oncologists with Grade IV operation qualification and the title of deputy director or above have gynecological examination, and the multidisciplinary team(MDT) evaluation recommended surgical treatment.
4. ECOG score:0 \~ 1.
5. The expected survival time\>6 months;
6. There is no absolute contraindication of surgery and the patients with good compliance.

Exclusion Criteria:

1. The radiotherapy and chemotherapy are not completed or the radiotherapy dose is not reached.
2. PET /CT and/or pathological indicates that there is a distant metastasis including para-aortic lymph nodes.
3. Other malignancies were diagnosed within five years or needed treatments.
4. History of important organ transplantation.
5. History of immune disease who need to take immunosuppressive drugs.
6. History of serious mental illness and brain functional disorder.
7. Drug abuse or drug use history.
8. Participants in other clinical trials at the same time.
9. Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements.
10. Without surgical conditions: 1) Chronic renal insufficiency or renal failure; 2) Liver insufficiency; 3)Chronic lung disease with restrictive respiratory dysfunction; 4) Cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians.
11. Patients who cannot understand the research regimen and refuse to sign the informed consent form.
12. Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.

Where it's running

• Chongqing Cancer Hospital
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Principal investigator: Dongling Zou, PH.D — Chongqing University Cancer Hospital
• Study coordinator: Dongling Zou, PH.D
• Email: cqzl_zdl@163.com
• Phone: 13657690699

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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.