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Trial Title:
The Correlation Between Tumor Angiogenesis and the Effect of Radiation Therapy in Cervical Cancer Patients
NCT ID:
NCT00155077
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
cervical cancer, chemoradiotherapy, angiogenesis
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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 2,720 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.
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 2,720 new cases of invasive carcinoma of the cervix and 971 deaths from
the disease, in addition to more than 3,566 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 involvement.(17, 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 metastasis(21). 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- cervical cancer patients receiving radiotherapy or chemo-radiotherapy
Exclusion Criteria:
-
Gender:
Female
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chao-Yuan Huang, M.D.
Phone:
886-2-2312-3456
Phone ext:
7635
Email:
cyh@ha.mc.ntu.edu.tw
Start date:
June 2004
Completion date:
June 2009
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on April 10, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00155077