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Trial Title:
The Efficacy of Salvage Surgery in Patients With Residual Tumor After Concurrent Chemoradiation for Locally Advanced Cervical Cancer.
NCT ID:
NCT05749887
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Locally advanced cervical cancer
chemoradiotherapy
redsidual tumor
salvage sugery
OS
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
salvage surgery
Description:
Open/minimally invasive salvage surgery performed when cervical biopsy and/or PET/CT scan
( SUVmax ≥2.5 ) indicate patients with residual tumor intrapelvic 4-12 weeks after
standard CCRT.
Surgery type:
1. No parametrial involvement, extrafascial hysterectomy;
2. There is parametrial involvement, extensive hysterectomy(Q-MC);
3. Only bladder invasion, anterior pelvic exenteration;
4. Only rectal invasion, posterior pelvic exenteration or total pelvic exenteration;
5. Invasion of bladder and rectum, total exenteration.
6. The pelvic lymph nodes are removed at the same time when 18F -FDG PET /CT indicates
that the SUVmax is ≥ 2.5.
Arm group label:
salvage sugery
Summary:
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Zou Dongling, PH.D.
Phone:
+8613657690699
Email:
cqzl_zdl@163.com
Start date:
August 25, 2023
Completion date:
December 31, 2032
Lead sponsor:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Source:
Chongqing University Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05749887
