RecruitingPhase 3NCT05277688

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

Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients With Selected Intermediate-risk Factors: a Randomized Controlled Phase III Trials (ACCEPT Trial)


Sponsor

Ruijin Hospital

Enrollment

340 participants

Start Date

Mar 15, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares radiation alone versus radiation combined with chemotherapy (concurrent chemoradiotherapy) for early-stage cervical cancer patients who have had a hysterectomy and have specific risk factors for recurrence. **You may be eligible if...** - You are 18–80 years old with confirmed cervical cancer (FIGO stage Ia2–IIb) - You had a radical hysterectomy 3–4 weeks before starting the study - Your post-surgery pathology shows specific intermediate-risk features (e.g., lymphovascular invasion with deep tumor invasion, large tumor size, or non-squamous cell type) - Your performance score is 70 or above (Karnofsky) - You have not received prior chemotherapy or radiation **You may NOT be eligible if...** - You have cancer remaining after surgery, or evidence of spread (lymph nodes, margins, or parametrial invasion) - You had pelvic or aortic lymph node metastases found at surgery - Your pathology showed positive surgical margins - You are not fit for radiation or chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGadjuvant concurrent chemoradiotherapy

concurrent chemotherapy: cisplatin(DDP) weekly, 40mg/m2, begin with radiation Drug: cisplatin(DDP) weekly; Intensity modulated radiotherapy (IMRT) is given five fractions per week at 1.8-2 Gy/fraction/day with total dose summed up to 45-50Gy.

RADIATIONradiotherapy

Intensity modulated radiotherapy (IMRT) is given five fractions per week at 1.8-2 Gy/fraction/day with total dose summed up to 45-50Gy.


Locations(2)

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, China

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, China

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NCT05277688


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