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

NCT ID: NCT05749887

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-25
• Study Completion Date: 2032-12-31

Brief 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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

salvage sugery

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)

Group Type: OTHER

salvage surgery

Intervention Type: PROCEDURE

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.

Interventions

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:

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chongqing University Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dongling Zou

Director of Gynecologic Oncology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dongling Zou, PH.D

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Cancer Hospital

Locations

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dongling Zou, PH.D

Role: CONTACT

cqzl_zdl@163.com

13657690699

Dongling Zou, PH.D

Role: CONTACT

Facility Contacts

Zou Dongling, PH.D.

Role: primary

cqzl_zdl@163.com

+8613657690699

Other Identifiers

CQGOG0112

Identifier Type: -

Identifier Source: org_study_id