Clinical trial NCT05277688: Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients
Official title: Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients With Selected Intermediate-risk Factors: a Randomized Controlled Phase III Trials (ACCEPT Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cervical Cancer
Keywords: cervical cancer
early stage
chemoradiotherapy
radiotherapy
survival
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 340
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 5-year recurrence-free survival
timeFrame: 5 years
Secondary outcomes:
measure: 5-year overall survival
timeFrame: 5 years
measure: Acute toxicity
timeFrame: 3 months
measure: Quality of Life (QoL)
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
state: Shanghai
Study officials:
References: