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Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Induction chemotherapy followed by cncurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a prospective randomized phase II study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003378
Enrollment
Unknown
Registered
2013-02-24
Start date
2013-03-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Experimental:Two circles induction chemotherapy (cisplatin and 5-fluorouraacil) with cisplatin 100 mg/m2(divided in 3 days)in 250 ml NS over 30 mins IV on and 5-fluorouraacil 1000 mg/m2/d in 5%GS cont
Active Comparator:Seven circles cisplatin 40 mg/m2 on Day 1 of every week and concurrent radiotherapy up to 70Gy

Sponsors

Tumor Center of Wuhan General Hospital of Guangzhou Military Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type); 2. Tumor staged as N2-3 or T3-4N1 (according to 6th American Joint Committee on Cancer staging system); 3. No evidence of distant metastasis (M0); 4. Performance status: KPS >=70; 5. With normal liver function test (Alanine AminotransferaseAspartate Aminotransferase =60ml/min; 7. Adequate marrow: leucocyte count >=4000/uL, hemoglobin >=80g/L and platelet count >=100000/uL; 8. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma; 2. Aged >=70 or <18; 3. With a history of renal disease; 4. Prior malignancy; 5. Previous chemotherapy or radiotherapy; 6. Patient is pregnant or lactating; 7. Unstable cardiac disease requiring treatment; 8. Emotion disturbance.

Design outcomes

Primary

MeasureTime frame
Response rate after the comprehensive treatment;Acute toxicity reaction;

Secondary

MeasureTime frame
1-year locoregional failure-free survival;1-year distant failure-free survival;1-year overall survival;

Contacts

Public ContactYi Feng-tao, Zhang Fan
flzxyft@163.com+86 13971490116, 18971252040

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026