NCT05277688

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Adjuvant therapy for patients with cervical cancer (CC) with intermediate-risk factors remains controversial. According to result of GOG 92 trail, adjuvant radiotherapy significantly improved recurrence-free survival in early stage cervical cancer with intermediate risks (Sedlis criteria). However, significant heterogeneity exists in Sedlis criteria, high risk of relapse and death occurred in patients with (1) lympho-vascular space invasion(LVSI+) and deep 1/3 stromal invasion;(2) LVSI(+) and middle 1/3 stromal invasion, and tumor size≥4cm when compared with other factors. In addition, multiple studies have confirmed that (3)non-squamous histology is an independent prognostic factor in early stage cervical cancer, who might be benefited from adjuvant concurrent chemoradiotherapy. As a result, The objective of the trial is 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. The primary endpoint of the study is the recurrence-free survival from the day of randomization.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	adjuvant 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.
RADIATION	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.

Timeline

• Start date: 2022-03-15
• Primary completion: 2025-12-30
• Completion: 2027-12-30
• First posted: 2022-03-14
• Last updated: 2022-09-16

Locations

2 sites across 1 country: China