Clinical trial · Interventional
The Efficacy of Salvage Surgery in Patients With Residual Tumor After Concurrent Chemoradiation for Locally Advanced Cervical Cancer.
Salvage Surgery for Patients With Residual Disease After Concurrent Chemoradiation Therapy for Locally Advanced Cervical Cancer: A Prospective, Single-arm Clinical Study.
NCT05749887CI-TRIAL-00070354recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-center single-arm study. The main purpose of this study is to study the efficacy of surgical treatment for patients with locally advanced cervical cancer (FIGO IB3, IIA2-IVA) who still have residual tumor after concurrent radiotherapy and chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| salvage surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- salvage sugery
- description
- Salvage surgery for patients diagnosed locally advanced cervical cancr with residual tumor after standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+ brachytherapy)
- interventionNames
- Procedure: salvage surgery
Primary outcomes (1)
- measure
- OS
- timeFrame
- 5 years
- description
- 5 years overall survival
Secondary outcomes (1)
- measure
- PFS
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.