Comparing chemoradiotherapy and radiotherapy for early-stage cervical cancer
Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients With Selected Intermediate-risk Factors: a Randomized Controlled Phase III Trials (ACCEPT Trial)
This study is testing if adding chemotherapy to radiation treatment helps women with early-stage cervical cancer who have had surgery to stay cancer-free longer than just radiation alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT05277688 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of adjuvant concurrent chemoradiotherapy compared to radiotherapy alone in patients with early-stage cervical cancer who have undergone radical surgery. It focuses on those with intermediate-risk factors, such as lympho-vascular space invasion and tumor size, to determine if the combination therapy improves recurrence-free survival. The study aims to clarify the benefits of chemoradiotherapy in a population that may have varying risks of relapse. The primary endpoint is the recurrence-free survival from the day of randomization.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 80 with histologically proven early-stage cervical cancer and specific intermediate-risk factors after radical hysterectomy.
Not a fit: Patients with postoperative recurrence, metastasis, or contraindications to radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival outcomes for patients with early-stage cervical cancer.
How similar studies have performed: Previous studies have shown that adjuvant radiotherapy can improve outcomes in similar patient populations, but the specific combination of chemoradiotherapy in this context is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
- Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wei-Xiang Qi, Dr.
- Email: qiweixiang1113@163.com
- Phone: +862164370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.