The Efficacy of Salvage Surgery in Patients With Residual Tumor After Concurrent Chemoradiation for Locally Advanced Cervical Cancer.

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05749887
• Other study ID #: CQGOG0112
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2023
• Est. completion date: December 31, 2032

Study information

• Verified date: October 2023
• Source: Chongqing University Cancer Hospital
• Contact: Dongling Zou, PH.D
• Phone: 13657690699
• Email: cqzl_zdl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 31, 2032
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• salvage surgery
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: No parametrial involvement, extrafascial hysterectomy; There is parametrial involvement, extensive hysterectomy(Q-MC); Only bladder invasion, anterior pelvic exenteration; Only rectal invasion, posterior pelvic exenteration or total pelvic exenteration; Invasion of bladder and rectum, total exenteration. The pelvic lymph nodes are removed at the same time when 18F -FDG PET /CT indicates that the SUVmax is = 2.5.

Locations

Country	Name	City	State
China	Chongqing Cancer Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing University Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	5 years overall survival	5 years
Secondary	PFS	Progression-free survival	2 years