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

NCT05749887 | Recruiting

• 1 other identifier: CQGOG0112
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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

Keywords

Locally advanced cervical cancer; chemoradiotherapy; redsidual tumor; salvage sugery; OS

Outcome Measures

Primary Outcomes (1)

• OS

  5 years overall survival

  5 years

Secondary Outcomes (1)

• PFS

  2 years

Study Arms (1)

salvage sugery

OTHER

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)

Procedure: salvage surgery

Interventions

salvage surgery 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.

salvage sugery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The radiotherapy and chemotherapy are not completed or the radiotherapy dose is not reached.
• PET /CT and/or pathological indicates that there is a distant metastasis including para-aortic lymph nodes.
• 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.
• Drug abuse or drug use history.
• Participants in other clinical trials at the same time.
• Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements.
• 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.
• Patients who cannot understand the research regimen and refuse to sign the informed consent form.
• Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Dongling Zou, PH.D

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongling Zou, PH.D

CONTACT

13657690699; cqzl_zdl@163.com

Dongling Zou, PH.D

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gynecologic Oncology Department

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 1, 2023
• Study Start: August 25, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

CN (1)