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NCT Number: NCT05749887

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

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location status: Recruiting

Location contact

Zou Dongling, PH.D.

CONTACT

[email protected]

+8613657690699

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ~ 1.
  • 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.

Treatment and study plan

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:

  • 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.

Primary outcomes

  1. OS

    Time frame: 5 years

    5 years overall survival

Secondary outcomes

  1. PFS

    Time frame: 2 years

    Progression-free survival

Study contacts

Contact information is provided by the study sponsor or research team.

Dongling Zou, PH.D

CONTACT

[email protected]

13657690699

Dongling Zou, PH.D

CONTACT

Sponsors and collaborators

Lead sponsor

Chongqing University Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2032
First posted
Mar 1, 2023
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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