Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
FEMALE
NCT05749887

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

Led by Chongqing University Cancer Hospital · Updated on 2023-10-10

188

Participants Needed

1

Research Sites

488 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients with stage IB3 and IIA2-IVA (FIGO2018) cervical cancer diagnosed as squamous cell carcinoma, adenosquamous cell carcinoma, or adenocarcinoma
  • Completed standard concurrent chemoradiotherapy including pelvic EBRT, concurrent platinum-containing chemotherapy, and brachytherapy
  • Residual cancer confirmed by cervical biopsy or negative biopsy but PET/CT showing SUVmax ≥ 2.5 in residual lesions 4-12 weeks after treatment
  • Evaluation by two or more gynecological oncologists with Grade IV operation qualification and multidisciplinary team recommendation for surgery
  • ECOG performance status score of 0 or 1
  • Expected survival time greater than 6 months
  • No absolute contraindications to surgery and good patient compliance
Not Eligible

You will not qualify if you...

  • Incomplete radiotherapy and chemotherapy or insufficient radiotherapy dose
  • Distant metastasis including para-aortic lymph nodes detected by PET/CT or pathology
  • Diagnosis of other malignancies within the past five years or requiring treatment
  • History of important organ transplantation
  • History of immune disease requiring immunosuppressive drugs
  • History of serious mental illness or brain functional disorders
  • History of drug abuse or current drug use
  • Participation in other clinical trials at the same time
  • Inability or unwillingness to accept surgical treatment, sign informed consent, or comply with research requirements
  • Surgical contraindications including chronic renal insufficiency, liver insufficiency, chronic lung disease with restrictive dysfunction, or cardiac dysfunction not cleared by cardiac physicians
  • Inability to understand the research protocol or refusal to sign informed consent
  • Other serious concomitant diseases or conditions that endanger health or interfere with the trial

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China, 400030

Actively Recruiting

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Research Team

D

Dongling Zou, PH.D

CONTACT

D

Dongling Zou, PH.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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