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Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients
Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients

NCT05277688

RecruitingPhase 3

Sponsor: Ruijin Hospital

Conditions: Cervical Cancer

Interventions: adjuvant concurrent chemoradiotherapy, radiotherapy

Countries: China

To evaluate if adjuvant concurrent chemoradiotherapy is associated with a recurrence-free survival benefit in comparison with radiotherapy alone in selected intermediate risk cervical cancer after radical surgery.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* • 18 Years to 80 Years

  * Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy
  * Accepted radical hysterectomy 3-4 weeks before
  * Karnofsky score \>70
  * Postoperative pathology with one of the three risk factors criterials: (1) lympho-vascular space invasion(LVSI+) and deep 1/3 stromal invasion; (2 ) LVSI(+) and middle 1/3 stromal invasion, and tumor size≥4cm (3)Non-squamous cell carcinoma;
  * Examination results showed no radiation or chemotherapy contraindication
  * Willing to accept treatment
  * Ability to comply with trial requirements

Exclusion Criteria:

* • Postoperative residual

  * Postoperative recurrence or metastasis
  * Pelvic lymph node metastasis
  * parametrial invasion
  * positive surgical margin
  * Without lymph node dissection
  * Postoperative pathology showed aortic lymph node metastasis
  * Examination results showed radiotherapy contraindications
  * No indications for radiotherapy
Locations (2)
  • Shanghai, Shanghai Municipality, China
  • Shanghai, Shanghai Municipality, China