| General information |
| Database: | DB00335 |
| Objective: | In order to assess the efficacy of nimotuzumab in combination with radiotherapy, a controlled, double blind, randomized clinical trial was conducted in 106 advanced squamous cell carcinoma of the head and neck patients, mostly, unfit for chemoradiotherapy. |
| Authors: | Rodr¨ªguez MO, et al |
| Title: | Nimotuzumab plus radiotherapy for unresectable squamouscell carcinoma of the head and neck. |
| Journal: | Cancer Biol Ther. |
| Year: | 2010 |
| PMID: | 20448462 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | nimotuzumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | Nimotuzumab plus radiotherapy |
| Study Type: | a controlled, double blind, randomizedphase III clinical trial |
| Key Patients Feature: | advanced squamous cell carcinoma of the head and neck patients, mostly, unfit for chemoradiotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | control:placebo+radiotherapy nimotuzumab:nimotuzumab+radiotherapy |
| Treatment Info: | In order to assess the efficacy of nimotuzumab in combination with radiotherapy, a controlled, double blind, randomized clinical trial was conducted in 106 advanced squamous cell carcinoma of the head and neck patients, mostly, unfit for chemoradiotherapy. Control patients received a placebo and radiotherapy. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 106 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Treatment was safe and the most frequent adverse events consisted on grade I or II asthenia, fever, headache and chills. No skin rash was detected. A significant complete response rate improvement was found in the group of patients treated with nimotuzumab as compared to the placebo. In the intent to treat analysis, a trend towards survival benefit for nimotuzumab treated subjects was found. The survival benefit became significant when applying the HarringtonFleming test, a weighted logrank that underscores the detection of differences deferred on time. In addition, a preliminary biomarker investigation showed a significant survival improvement for nimotuzumab treated patients as compared to controls for subjects with EGFR positive tumors. All patients showed a quality of life improvement and a reduction of the general and specific symptoms of the disease. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | A significant complete response rate improvement was found in the group of patients treated with nimotuzumab as compared to the placebo. In the intent to treat analysis, a trend towards survival benefit for nimotuzumab treated subjects was found. The survival benefit became significant when applying the HarringtonFleming test, a theyighted logrank that underscores the detection of differences deferred on time. In addition, a preliminary biomarker investigation showed a significant survival improvement for nimotuzumab treated patients as compared to controls for subjects with EGFR positive tumors. All patients showed a quality of life improvement and a reduction of the general and specific symptoms of the disease. |