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

Who is this study for? Patients with early-stage cervical cancer with slected intermediate-risk factors
What treatments are being studied? Adjuvant concurrent chemoradiotherapy
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• • 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

Locations
Other Locations
China
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
NOT_YET_RECRUITING
Shanghai
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
RECRUITING
Shanghai
Contact Information
Primary
Wei-Xiang Qi, Dr.
qiweixiang1113@163.com
+862164370045
Time Frame
Start Date: 2022-03-15
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 340
Treatments
Experimental: experimental group
concurrent chemotherapy: cisplatin(DDP) weekly, 40mg/m2, begin with radiation Drug: cisplatin(DDP) weekly; pelvic radiotherapy: 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.
Active_comparator: controlled group
pelvic radiotherapy alone: 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.
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

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