Evaluating surgery for cervical cancer patients with remaining tumors after treatment

Salvage Surgery for Patients With Residual Disease After Concurrent Chemoradiation Therapy for Locally Advanced Cervical Cancer: A Prospective, Single-arm Clinical Study.

This study is testing if surgery can help women with locally advanced cervical cancer who still have leftover tumors after their initial treatment feel better and improve their chances of recovery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Chongqing University Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT05749887 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with FIGO stage Ib3 and IIA2-IVA cervical cancer who have residual tumors after completing chemoradiotherapy.

Not a fit: Patients who have not completed their radiotherapy and chemotherapy or those with contraindications to surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option that improves survival rates for patients with residual cervical cancer.

How similar studies have performed: While there is limited data on this specific approach, similar studies have shown promise in evaluating surgical options for patients with residual tumors after chemoradiation.

Eligibility criteria

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 this trial is running

Chongqing, Chongqing Municipality

• 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

Conditions Cervical Cancer; Locally advanced cervical cancer; chemoradiotherapy; redsidual tumor; salvage sugery; OS