NCT04136886 Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma
| NCT ID | NCT04136886 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 346 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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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 346 participants in total. It began in 2020-01-01 with a primary completion date of 2027-12.
⚠ 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
The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.
Eligibility Criteria
Inclusion Criteria: * 1.Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma; 2.No evidence of distant metastasis 3.More than 1 year from the end of the first course of radiotherapy 4.Male, or female not in the phase of lactating or pregnancy 5.ECOG 0-2 6.Aged 18-70 years old 7.WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L 8.Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits 9.Written informed consort signed Exclusion Criteria: 1. Only regionally recurrence 2. Evidence of distant metastasis 3. Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted 4. Severe, active co-morbidity 5. Prior anti-tumor treatment after diagnosis of local recurrence 6. MRI was not performed 3 months after the first course of radiotherapy 7. Abnormal function of heart, brain and lungs, etc 8. Lactation or pregnancy 9. Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04136886 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Nasopharyngeal Carcinoma. 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 NCT04136886 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 346 participants.
Is NCT04136886 currently recruiting?
Yes, NCT04136886 is actively recruiting participants. Contact the research team at hanfei@sysucc.org.cn for enrollment information.
Where is the NCT04136886 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT04136886 clinical trial?
NCT04136886 is sponsored by Sun Yat-sen University. The trial plans to enroll 346 participants.