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Spots Global Cancer Trial Database for p53 Gene Therapy for Head and Neck Malignant Tumors in Advanced Stage

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Trial Identification

Brief Title: p53 Gene Therapy for Head and Neck Malignant Tumors in Advanced Stage

Official Title: Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Therapy Combined With Chemotherapy and Radiotherapy in Treament of Head and Neck Cancer in Advanced Stage

Study ID: NCT00894153

Conditions

Neoplasms

Study Description

Brief Summary: This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent chemotherapy , with concurrent radiotherapy, or combination with surgery for treatment of head and neck malignant tumors in advanced stage .

Detailed Description: Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with concurrent chemotherapy, with concurrent radiotherapy, or combination with surgery for treatment of head and neck malignant tumors in advanced stage (stage III or IV) including target lesion complete response rate (LCR) and overall target lesion response rate (OLR), response duration (RD), and progress-free survival (PFS). The secondary objectives of this study is to investigate overall response rate (OPCR) and overall complete response rate (OCR), overall survival (OS), ECOG, and safety of rAd-p53 monotherapy and combined with chemotherapy, radiotherapy or surgery.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Department of oral and maxillofacial surgery, Huaxi university of medical science, Chendu, Shichuan, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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