Surgery for Residual Cervical Cancer After Chemoradiation
The Efficacy of Salvage Surgery in Patients With Residual Tumor After Concurrent Chemoradiation for Locally Advanced Cervical Cancer.
Recruiting
N/AInterventional Study
Cervical Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
188 (estimated)
Sponsor
Chongqing University Cancer Hospital · Other
Who this trial is looking for
This trial is looking for patients with locally advanced cervical cancer who still have cancer left after treatment. Participants will undergo a surgical procedure to remove any remaining cancer.
Are You a Good Fit for This Trial?
Rules you outChronic renal insufficiencyLiver insufficiencyChronic lung disease with restrictive respiratory dysfunctionCardiac dysfunction
You may be able to join if
I have stage Ib3 or IIA2-IVA cervical cancer.
I have completed standard treatment that includes radiotherapy and chemotherapy.
I have been confirmed to have leftover cancer after treatment.
I have an ECOG score of 0 or 1.
I expect to survive for more than 6 months.
I can comply with treatment and follow the study's requirements.
You may not be able to join if
I haven’t finished my radiotherapy and chemotherapy.
I have distant cancer spread, including to lymph nodes.
I have been diagnosed with another cancer in the last 5 years.
I have received an important organ transplant.
I have a history of immune disease that requires immunosuppressive drugs.
I have serious mental health issues or brain problems.
I have a history of drug abuse.
I am currently participating in another clinical trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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…
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.
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