Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155077
Status:
UNKNOWN
Last Update Posted:
2005-10-20
First Post:
2005-09-09
Brief Title:
The Correlation Between Tumor Angiogenesis and the Effect of Radiation Therapy in Cervical Cancer Patients
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The Correlation Between Tumor Angiogenesis and the Effect of Radiation Therapy in Cervical Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2004-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Carcinoma of the uterine cervix is a serious health problem Cervical cancer is the most common malignant neoplasm of women in Taiwan There were 2720 new cases of invasive carcinoma of the cervix and 971 deaths from the disease in 2000 Cervical cancer is indeed is an important disease in Taiwan
The primary therapies for cervical cancer are surgery radiotherapy or chemoradiotherapy Several clinical trials have showed that an improvement in time to progression and survival for patients given chemoradiotherapy compared with radiotherapy alone Chemoradiotherapy is now regarded as standard modality to treat the locally advanced stage IIB-IVA or high-risk early-stage cervical cancer However some of the cervical cancer patients still failed to response to the treatment of cervical cancer or relapsed for completion of treatment
Angiogenesis plays an important role in the pathogenesis of cancer Recent studies have related angiogenesis to cancer growth and metastasis Ultrasonography has been used in the gynecologic field for decades The previous studies of our team have shown that incremental angiogenesis could be demonstrated in the tumorigenesis of ovarian endometrial malignancies and cervical caner Besides other growth factors such as vascular endothelial growth factor VEGF and IL-6 have also been reported to correlate with the angiogenesis and the prognosis of cervical cancer It seems that tumor angiogenesis could be utilized as a good marker to survey the severity of disease and prognosis of early-staged cervical cancer patients
There is no good method or marker which could be utilized to monitor the response of radiotherapy and evaluate the prognosis of cervical cancer patients with advanced stages So we would like to propose this proposal to focus on the tumor angiogenesis in cervical cancer patients with advanced stages There are several purposes in this study First we will evaluate the kinetic changes of tumor angiogenesis in cervical cancer patients who receive radiotherapy or concurrent chemoradiotherapy Second we will evaluate that if the tumor angiogenesis could be a marker to monitor the response of radiotherapy or chemoradiotherapy in cervical cancer patients The relation between tumor angiogenesis and radiotherapy will be explored and clarified by this study The comprehensive role of tumor angiogenesis in cervical cancer will be elucidated by the results of this study
The primary therapies for cervical cancer are surgery radiotherapy or chemoradiotherapy Several clinical trials have showed that an improvement in time to progression and survival for patients given chemoradiotherapy compared with radiotherapy alone Chemoradiotherapy is now regarded as standard modality to treat the locally advanced stage IIB-IVA or high-risk early-stage cervical cancer However some of the cervical cancer patients still failed to response to the treatment of cervical cancer or relapsed for completion of treatment
Angiogenesis plays an important role in the pathogenesis of cancer Recent studies have related angiogenesis to cancer growth and metastasis Ultrasonography has been used in the gynecologic field for decades The previous studies of our team have shown that incremental angiogenesis could be demonstrated in the tumorigenesis of ovarian endometrial malignancies and cervical caner Besides other growth factors such as vascular endothelial growth factor VEGF and IL-6 have also been reported to correlate with the angiogenesis and the prognosis of cervical cancer It seems that tumor angiogenesis could be utilized as a good marker to survey the severity of disease and prognosis of early-staged cervical cancer patients
There is no good method or marker which could be utilized to monitor the response of radiotherapy and evaluate the prognosis of cervical cancer patients with advanced stages So we would like to propose this proposal to focus on the tumor angiogenesis in cervical cancer patients with advanced stages There are several purposes in this study First we will evaluate the kinetic changes of tumor angiogenesis in cervical cancer patients who receive radiotherapy or concurrent chemoradiotherapy Second we will evaluate that if the tumor angiogenesis could be a marker to monitor the response of radiotherapy or chemoradiotherapy in cervical cancer patients The relation between tumor angiogenesis and radiotherapy will be explored and clarified by this study The comprehensive role of tumor angiogenesis in cervical cancer will be elucidated by the results of this study
Detailed Description:
Carcinoma of the uterine cervix is a serious health problem In Taiwan cervical cancer is the most common malignant neoplasm and the 5th leading cause of cancer deaths in women after carcinoma of the lung liver colorectum and breast The Department of Health estimated that in 2000 there were 2720 new cases of invasive carcinoma of the cervix and 971 deaths from the disease in addition to more than 3566 cases of carcinoma in situ 1
The traditional treatment of invasive cervical cancer has been by surgery or radiotherapy or certain situations a combination of both Most women with early-stage cervical cancers can be cured with radical surgery or radiotherapy Those with a large cervical lesion at presentation or with spread to the pelvic lymph nodes or other pelvic tissues are usually treated with a combination of external-beam and intracavitary radiation 2-6 To eradicate micrometastases and sensitize tumor cells to radiation several studies have explored the use of radiotherapy with concomitant chemotherapy 7-10 Because patients with cervical cancer usually present with disease that is clinically confined to the pelvis locoregional disease control is the primary challenge for physicians Treatment with carefully tailored surgery or radiotherapy has produced impressive cure rates in patients with early-stage disease Primary radiotherapy for early-stage disease offers cure rates equivalent to those with radical hysterectomy For more locally advanced disease with spread beyond the uterus stage IIB to IVA according to the staging system of the International Federation of Gynecology and Obstetrics radiotherapy is the primary modality of treatment For these patients cure rates decrease with advancing stage and tumor bulk 11 A significant reason for treatment failure in many patients is the inability to achieve control over the primary cancer and first-echelon lymph node metastases 12 Improvement in local control can be expected to lead to improved cure rates 13 Simply increasing the dose of RT will increase local control rates but it does so at the expense of increased complication rates 14 Once cervical cancer has extended beyond the cervix cure with radical surgery alone is unlikely After reports from several randomized clinical trials showing an improvement in time to progression and survival for patients given chemoradiotherapy compared with radiotherapy alone 15-18 the chemoradiotherapy should be considered as standard care for locally advanced stage IIB-IVA or high-risk early-stage cervical cancer
Radical radiotherapy is effective for patients with locoregionally confined cervical cancer of any stage Treatment must be carefully tailored to the patient and to the extent of disease but usually consists of a combination of external-beam irradiation and brachytherapy Overall reported 5-year survival rates of patients treated with radiation alone are approximately 75 to 85 for stage IB 65 to 75 for stage II 30 to 50 for stage III and 10 to 20 for stage IVA disease Within stage subsets cure rates are strongly correlated with the size of the primary tumor and the extent of regional involvement17 18 For locally advanced disease a systematic review and meta-analysis of reports on the use of chemoradiotherapy generally supported the use of chemoradiotherapy over radiotherapy alone or neoadjuvant chemotherapy followed by radiotherapy 19 Chemoradiotherapy showed to improve overall survival by about 30 and reduced the risk of both local and distant recurrence Absolute survival benefit was estimated as 12 though several studies have reported higher survival benefits
Angiogenesis plays an important role in the pathogenesis of cancer 20 Recent studies have related angiogenesis to cancer growth and metastasis21 The growth of solid tumors and their metastatic spread is angiogenesis dependent and this has been confirmed in several experimental and clinical studies 22 23 Ultrasonography has been used in the gynecologic field for decades Our previous studies have shown that incremental angiogenesis could be demonstrated in the tumorigenesis of ovarian endometrial malignancies and cervical caner 24-28 Besides other growth factors such as vascular endothelial growth factor VEGF and IL-6 have also been reported to correlate with the angiogenesis and the prognosis of cervical cancer 29-31 ovarian cancer 32 and endometrial cancer 27 33 Tumor angiogenesis of cervical cancer has been proved to be correlated with the disease severity and prognosis of the cervical cancer patients with early stages 26 29 30 34 It seems that tumor angiogenesis could be utilized as a good marker to survey the severity of disease and prognosis of early-staged cervical cancer patients
However there is no good method or marker which could be utilized to monitor the response of radiotherapy and evaluate the prognosis of cervical cancer patients with advanced stages So we would like to propose this proposal to focus on the tumor angiogenesis in cervical cancer patients with advanced stages Cervical cancer patients who will receive radiotherapy or concurrent chemoradiotherapy will be enrolled in this study Transvaginal sonography and angiogenesis-related growth factors will be evaluated to monitor and response of treatment in each patient There are several purposes in this study First we will evaluate the kinetic changes of tumor angiogenesis in cervical cancer patients who receive radiotherapy or concurrent chemoradiotherapy Second we will evaluate that if the tumor angiogenesis could be a marker to monitor the response of radiotherapy or concurrent chemoradiotherapy in cervical cancer patients The relation between tumor angiogenesis and radiotherapy will be explored and clarified by this study The comprehensive role of tumor angiogenesis in cervical cancer will be elucidated by the results of this study
The traditional treatment of invasive cervical cancer has been by surgery or radiotherapy or certain situations a combination of both Most women with early-stage cervical cancers can be cured with radical surgery or radiotherapy Those with a large cervical lesion at presentation or with spread to the pelvic lymph nodes or other pelvic tissues are usually treated with a combination of external-beam and intracavitary radiation 2-6 To eradicate micrometastases and sensitize tumor cells to radiation several studies have explored the use of radiotherapy with concomitant chemotherapy 7-10 Because patients with cervical cancer usually present with disease that is clinically confined to the pelvis locoregional disease control is the primary challenge for physicians Treatment with carefully tailored surgery or radiotherapy has produced impressive cure rates in patients with early-stage disease Primary radiotherapy for early-stage disease offers cure rates equivalent to those with radical hysterectomy For more locally advanced disease with spread beyond the uterus stage IIB to IVA according to the staging system of the International Federation of Gynecology and Obstetrics radiotherapy is the primary modality of treatment For these patients cure rates decrease with advancing stage and tumor bulk 11 A significant reason for treatment failure in many patients is the inability to achieve control over the primary cancer and first-echelon lymph node metastases 12 Improvement in local control can be expected to lead to improved cure rates 13 Simply increasing the dose of RT will increase local control rates but it does so at the expense of increased complication rates 14 Once cervical cancer has extended beyond the cervix cure with radical surgery alone is unlikely After reports from several randomized clinical trials showing an improvement in time to progression and survival for patients given chemoradiotherapy compared with radiotherapy alone 15-18 the chemoradiotherapy should be considered as standard care for locally advanced stage IIB-IVA or high-risk early-stage cervical cancer
Radical radiotherapy is effective for patients with locoregionally confined cervical cancer of any stage Treatment must be carefully tailored to the patient and to the extent of disease but usually consists of a combination of external-beam irradiation and brachytherapy Overall reported 5-year survival rates of patients treated with radiation alone are approximately 75 to 85 for stage IB 65 to 75 for stage II 30 to 50 for stage III and 10 to 20 for stage IVA disease Within stage subsets cure rates are strongly correlated with the size of the primary tumor and the extent of regional involvement17 18 For locally advanced disease a systematic review and meta-analysis of reports on the use of chemoradiotherapy generally supported the use of chemoradiotherapy over radiotherapy alone or neoadjuvant chemotherapy followed by radiotherapy 19 Chemoradiotherapy showed to improve overall survival by about 30 and reduced the risk of both local and distant recurrence Absolute survival benefit was estimated as 12 though several studies have reported higher survival benefits
Angiogenesis plays an important role in the pathogenesis of cancer 20 Recent studies have related angiogenesis to cancer growth and metastasis21 The growth of solid tumors and their metastatic spread is angiogenesis dependent and this has been confirmed in several experimental and clinical studies 22 23 Ultrasonography has been used in the gynecologic field for decades Our previous studies have shown that incremental angiogenesis could be demonstrated in the tumorigenesis of ovarian endometrial malignancies and cervical caner 24-28 Besides other growth factors such as vascular endothelial growth factor VEGF and IL-6 have also been reported to correlate with the angiogenesis and the prognosis of cervical cancer 29-31 ovarian cancer 32 and endometrial cancer 27 33 Tumor angiogenesis of cervical cancer has been proved to be correlated with the disease severity and prognosis of the cervical cancer patients with early stages 26 29 30 34 It seems that tumor angiogenesis could be utilized as a good marker to survey the severity of disease and prognosis of early-staged cervical cancer patients
However there is no good method or marker which could be utilized to monitor the response of radiotherapy and evaluate the prognosis of cervical cancer patients with advanced stages So we would like to propose this proposal to focus on the tumor angiogenesis in cervical cancer patients with advanced stages Cervical cancer patients who will receive radiotherapy or concurrent chemoradiotherapy will be enrolled in this study Transvaginal sonography and angiogenesis-related growth factors will be evaluated to monitor and response of treatment in each patient There are several purposes in this study First we will evaluate the kinetic changes of tumor angiogenesis in cervical cancer patients who receive radiotherapy or concurrent chemoradiotherapy Second we will evaluate that if the tumor angiogenesis could be a marker to monitor the response of radiotherapy or concurrent chemoradiotherapy in cervical cancer patients The relation between tumor angiogenesis and radiotherapy will be explored and clarified by this study The comprehensive role of tumor angiogenesis in cervical cancer will be elucidated by the results of this study
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