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

RECRUITINGPhase 3Sponsored by Ruijin Hospital
Actively Recruiting
PhasePhase 3
SponsorRuijin Hospital
Started2022-03-15
Est. completion2025-12-30
Eligibility
Age18 Years – 80 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05277688

Summary

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

Age: 18 Years – 80 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions2

CancerCervical Cancer

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