Ignite Creation Date:
2024-05-06 @ 12:34 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01606566
Status:
TERMINATED
Last Update Posted:
2022-02-18
First Post:
2012-05-21
Brief Title:
A Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin for Recurrent Head and Neck Cancer
Sponsor:
PCI Biotech AS
Organization:
PCI Biotech AS
Study Overview
Official Title:
Open-label Single Arm Multi-centre Phase II Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin With Superficial and Interstitial Laser Light Application in Patients With Recurrent Head and Neck Cancer
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Amphinex induced PCI of bleomycin PC-A11 with superficial andor interstitial laser light application in patients with recurrent SCCHN
Detailed Description:
Approximately 650 000 new cases of head and neck cancer are diagnosed worldwide each year 2 Europe alone it is estimated that there are approximately 143 000 new cases and more than 68 000 deaths each year 3 The vast majority 90 of head and neck malignancies are squamous cell carcinomas Most 60-70 patients with squamous cell carcinoma of the head and neck SCCHN present with loco regionally advanced disease
Standard treatment options for SCCHN include surgery radiotherapy and chemotherapy Single-modality treatment with surgery or radiotherapy is generally recommended for the 40 of patients who present stage I or II disease Each of the two modalities results in similar survival with cure rates ranging between 60 and 90
For the 60 of the patients who present with locally advanced disease at diagnosis combined modality therapy is generally recommended For patients with unresectable disease the current standard treatment is concurrent cisplatin-based chemoradiation This is also the standard for patients with resectable disease when organ preservation is desired and as adjuvant treatment for patients with high-risk pathological findings at surgical resection
Despite such an approach a substantial percentage of patients 20-30 develop local andor regional recurrences and distant metastases Recurrent disease is often not resectable and even in resectable cases some patients decline the surgical procedure due to quality of life considerations Additionally in recurrent disease the radiation tolerance of the normal tissues makes re-irradiation technically challenging and frequently more toxic than the initial course The prognosis of patients with recurrent or metastatic SCCHN is generally poor with a median survival of 6-9 months
The therapeutic ratio in recurrent SCCHN is narrow Therefore there is a large unmet medical need for novel treatments in this patient group both to lengthen overall survival and to improve the patients quality of life
Standard treatment options for SCCHN include surgery radiotherapy and chemotherapy Single-modality treatment with surgery or radiotherapy is generally recommended for the 40 of patients who present stage I or II disease Each of the two modalities results in similar survival with cure rates ranging between 60 and 90
For the 60 of the patients who present with locally advanced disease at diagnosis combined modality therapy is generally recommended For patients with unresectable disease the current standard treatment is concurrent cisplatin-based chemoradiation This is also the standard for patients with resectable disease when organ preservation is desired and as adjuvant treatment for patients with high-risk pathological findings at surgical resection
Despite such an approach a substantial percentage of patients 20-30 develop local andor regional recurrences and distant metastases Recurrent disease is often not resectable and even in resectable cases some patients decline the surgical procedure due to quality of life considerations Additionally in recurrent disease the radiation tolerance of the normal tissues makes re-irradiation technically challenging and frequently more toxic than the initial course The prognosis of patients with recurrent or metastatic SCCHN is generally poor with a median survival of 6-9 months
The therapeutic ratio in recurrent SCCHN is narrow Therefore there is a large unmet medical need for novel treatments in this patient group both to lengthen overall survival and to improve the patients quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-003751-19 | EUDRACT_NUMBER | None | None |