NCT05277688 Adjuvant Concurrent Chemoradiotherapy Versus Radiotherapy in Early-stage Cervical Cancer Patients
| NCT ID | NCT05277688 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ruijin Hospital |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2022-03-15 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 340 participants in total. It began in 2022-03-15 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05277688 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05277688 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 340 participants.
Is NCT05277688 currently recruiting?
Yes, NCT05277688 is actively recruiting participants. Contact the research team at qiweixiang1113@163.com for enrollment information.
Where is the NCT05277688 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT05277688 clinical trial?
NCT05277688 is sponsored by Ruijin Hospital. The trial plans to enroll 340 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.