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A phase 2, randomized, controlled trial of intensity modulated radiotherapy (IMRT) plus induction chemotherapy with docetaxel+cisplatin/cisplatin (TP/DDP) compared to IMRT plus concurrent TP/DDP in locally advanced nasopharyngeal carcinoma.

A phase 2, randomized, controlled trial of intensity modulated radiotherapy (IMRT) plus induction chemotherapy with docetaxel+cisplatin/cisplatin (TP/DDP) compared to IMRT plus concurrent TP/DDP in locally advanced nasopharyngeal carcinoma.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004341
Enrollment
Unknown
Registered
2014-03-04
Start date
2014-03-01
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

1:IMRT+ induction chemotherapy
2:IMRT+concurrent chemotherapy

Sponsors

Cancer Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. Patients with newly histologically confirmed non-keratinizing (WHO type II/III according to WHO histologically type); 2. Tumor staged as T3-4N0-3/T1-2N2-3 (according to the 7th AJCC edition); 3. No evidence of distant metastasis (M0); 4. ECOG PS 0-2; 5. Aged 18~70 years; 6. Male or female without pregnancy or lactation; 7. Adequate marrow: leucocyte count > 4×10^9/L, neutrophil count > 2×10^9/L, hemoglobin > 90g/L and platelet count > 100×10^9/L; 8. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) 60 ml/min; 10. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion criteria

Exclusion criteria: 1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma; 2. Treatment with palliative intent; 3. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer; 4. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period); 5. History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume); 6. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes; 7. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.

Design outcomes

Primary

MeasureTime frame
short term effect;2-year PF;

Secondary

MeasureTime frame
OS;locoregional recurrent-free survival rate (LRRFS);distant metastasis-free survival rate(DMFS);toxicity;

Countries

China

Contacts

Public ContactMei Li & Zhi-xiong Lin

Cancer Hospital of Shantou University Medical College

limei00182@139.com+86 754 88555844-1137

Outcome results

None listed

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