NCT05749887Recruiting
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.
Source: ClinicalTrials.gov · Last updated 10 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 188 (estimated)
- First submitted
- 20 Feb 2023
- Start date
- 25 Aug 2023
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Chongqing University Cancer Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT05749887
What you commit to
- Study type: Interventional
- Planned participants: 188
- From 25 Aug 2023 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The radiotherapy and chemotherapy are not completed or the radiotherapy dose is not reached.
- Drug abuse or drug use history.
- Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements.
- Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
Other illness
- Other malignancies were diagnosed within five years or needed treatments.
- History of important organ transplantation.
- History of immune disease who need to take immunosuppressive drugs.
- History of serious mental illness and brain functional disorder.
- 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.
Other
- PET /CT and/or pathological indicates that there is a distant metastasis including para-aortic lymph nodes.
- Participants in other clinical trials at the same time.
- Patients who cannot understand the research regimen and refuse to sign the informed consent form.
Who the study is looking for
- Stage Ib3 and IIA2-IVA (FIGO2018) cervical cancer with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma.
- Complete standard CCRT(Pelvic EBRT+ concurrent platinum-containing chemotherapy+ brachytherapy).
- 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.
- ECOG score:0 \~ 1.
- The expected survival time\>6 months;
- There is no absolute contraindication of surgery and the patients with good compliance.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chongqing Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.