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Multicentre Randomization Clinic Trial of Systemic Chemotherapy Combined with Loco-regional Radiotherapy vs. Chemotherapy alone for Initially Untreated Distant Metastatic Nasopharyngeal Carcinoma with Chemosensitivity

Multicentre Randomization Clinic Trial of Systemic Chemotherapy Combined with Loco-regional Radiotherapy vs. Chemotherapy alone for Initially Untreated Distant Metastatic Nasopharyngeal Carcinoma with Chemosensitivity

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003217
Enrollment
Unknown
Registered
2013-05-06
Start date
2013-07-01
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

A:Radiotherapy In Primary Lesion Plus General Chemotherapy
B:Simple Chemotherapy

Sponsors

Nasopharyngeal Carcinoma Department of Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The patients with initial untreated metastatic nasopharyngeal carcinoma; 2. Histologic diagnosis of nasopharyngeal carcinoma; 3. T1-4N0-3M1,IVC (UICC 7th edition); 4. Aged between 18 and 65 years; 5. KPS>=70; 6. The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin and 5-Fu; 7. Voluntary to participate and sign informed consent document.

Exclusion criteria

Exclusion criteria: 1. Sufferred from serious neurologic disease; 2. Clinically significant cardiac, heart function less than or equal to 3 level; 3. Clinically significant respiratory disease,lung function less than or equal to 3 level; 4. blood routine examination:WBC count2*ULN; 6. Abnormal renal function:serum creatinine>1.5*ULN; 7. Pregnant or lactating women; 8.The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin and 5-Fu.

Design outcomes

Primary

MeasureTime frame
overall survival rate;Progession-free survival;Time to progression;Quality of life;disease free survival rate;Overall objective rate;

Countries

China

Contacts

Public ContactMingyuan Chen
chmingy@mail.sysu.edu.cn+86 13903052650

Outcome results

None listed

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