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Clinical Trials/NCT05749887
NCT05749887RecruitingNot Applicable

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

Chongqing University Cancer Hospital1 site in 1 country188 target enrollmentStarted: August 25, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
188
Locations
1
Primary Endpoint
OS
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 ~
  • •The expected survival time>6 months;
  • •There is no absolute contraindication of surgery and the patients with good compliance.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

OS

Time Frame: 5 years

5 years overall survival

Secondary Outcomes

  • PFS(2 years)

Investigators

Sponsor
Chongqing University Cancer Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dongling Zou

Director of Gynecologic Oncology Department

Chongqing University Cancer Hospital

Study Sites (1)

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