Concurrent chemotherapy with IMRT for recurrent nasopharyngeal carcinoma
Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT)
This study is testing if adding chemotherapy with cisplatin to radiation therapy helps people with recurrent nasopharyngeal cancer do better and experience fewer side effects compared to just radiation alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 346 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04136886 on ClinicalTrials.gov |
What this trial studies
This phase III randomized controlled study aims to evaluate the effectiveness of concurrent chemotherapy using cisplatin combined with intensity-modulated radiotherapy (IMRT) in patients with locally recurrent T3/T4 nasopharyngeal carcinoma. The study compares this combination treatment to IMRT alone to determine if it improves local control of the cancer and reduces severe late toxicities. Eligible participants include those who have pathologically confirmed recurrent NPC and meet specific health criteria. The study is designed to provide insights into better treatment options for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with confirmed locally recurrent T3/T4 nasopharyngeal carcinoma who have not experienced distant metastasis.
Not a fit: Patients with only regional recurrence or evidence of distant metastasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and quality of life for patients with recurrent nasopharyngeal carcinoma.
How similar studies have performed: Other studies have shown promising results with concurrent chemotherapy and radiotherapy approaches in similar cancer types, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- WangHanYu — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Fei Han, doctor
- Email: hanfei@sysucc.org.cn
- Phone: 8620-87343030
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.