Actively Recruiting

Phase 3
Age: 18Years - 80Years
FEMALE
NCT05277688

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

Led by Ruijin Hospital · Updated on 2022-09-16

340

Participants Needed

2

Research Sites

302 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 80 years
  • Histologically confirmed cervical cancer, FIGO stage Ia2 to IIb, with no prior chemotherapy or radiotherapy
  • Radical hysterectomy performed 3 to 4 weeks before enrollment
  • Karnofsky performance score greater than 70
  • Postoperative pathology showing at least one intermediate-risk factor: (1) lympho-vascular space invasion (LVSI+) with deep one-third stromal invasion; (2) LVSI(+) with middle one-third stromal invasion and tumor size 64 cm; or (3) non-squamous cell carcinoma
  • No contraindications to radiation or chemotherapy based on examination results
  • Willingness to accept treatment
  • Ability to comply with trial requirements
Not Eligible

You will not qualify if you...

  • Presence of postoperative residual tumor
  • Postoperative recurrence or metastasis
  • Pelvic lymph node metastasis
  • Parametrial invasion
  • Positive surgical margins
  • No lymph node dissection performed
  • Postoperative pathology showing aortic lymph node metastasis
  • Examination results indicating contraindications to radiotherapy
  • No indications for radiotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, China, 200025

Not Yet Recruiting

2

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

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Research Team

W

Wei-Xiang Qi, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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