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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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 rec

Первичные конечные точки

• OS [Срок оценки: 5 years]

Вторичные конечные точки (1)

• PFS [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chongqing Cancer Hospital — Чунцин

Идентификаторы

NCT: NCT05749887 · CQGOG0112

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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