A prospective comparative study of IMRT (using VMAT technique) versus 3DCRT with respect to toxicity and loco-regional response in locally advanced cervical carcinoma
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1) To compare acute hematological, gastro-intestinal and genitourinary toxicities between IMRT (using VMAT technique) and 3DCRT in patients of cervical cancer (FIGO stage IB3-IIIB).
研究概览
简要总结
Conventional pelvic radiotherapy techniques typically use opposed antero-posterior/ postero-anterior and lateral fields according to bony anatomy. Resulting in a box shaped dose distribution that encompasses both the target (eg. tumor, parametria, pelvic lymph nodes) and normal tissues (eg. Bowel, Rectum, Bladder, Bone marrow).The hematopoietic stem cells of bone marrow are very sensitive to radiation. It is shown that increased dose to the bone marrow and increased volume of bone marrow in the field of radiation can proportionately increase the risk of acute hematological toxicities. Nearly 50% of body bone marrow is in pelvic and neighboring bones which come in the field of radiation in the treatment of carcinoma cervix. The conventional two dimensional fields irradiate a large volume of bone marrow which in addition to myelotoxic effects of chemotherapy results in more severe hematological toxicities. With the introduction of CT based treatment planning, the technique of 3DCRT offers better target coverage and significantly reduces the amount of radiation exposure to bladder. However, this technique did not appreciably reduce the amount of radiation exposure to the intestines, rectum, bone marrow, In contrast to 3DCRT which uses uniform fields, IMRT (using VMAT technique) generates non-uniform fields to achieve better planning target volume coverage, while decreasing unnecessary radiation exposures to the normal organs including red marrow. IMRT (using VMAT technique) advantage has been proven in several anatomical sites such as head and neck cancers. Large and frequent changes in target positioning due to organ motion, uncertainties in target position and wide variation in methods have also resulted in a lack of consensus regarding the best IMRT (using VMAT technique) approach in gynecological cancer and the benefit of using IMRT (using VMAT technique) in the field of gynecological cancer is still under evaluation and there is potential to reduce toxicities. So, we will conduct a prospective study to compare the severity of acute gastro-intestinal, genito-urinary and hematological toxicities and loco-regional response between 3DCRT and IMRT (using VMAT technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Histopathology confirmed primary carcinoma of cervix.
- •Histopathology- squamous cell carcinoma.
- •Intact and non-operated cervical carcinoma cases (wherever concurrent chemo-radiotherapy is indicated).
- •FIGO stage IB3 to IIIB.
- •Age 18 yrs – 70 years.
- •No prior history of chemotherapy or pelvic radiotherapy.
- •WHO performance status grade 0 to 2 8) liver function test with in 2 times of upper normal level 9) hematological parameters with in normal limit and kidney function test within normal limit 10) Patients with no history or current clinical evidence of any Hematological or Bleeding disorders.
- •HBsAG, Anti-HCV, HIV non-reactive patients.
- •No history of drug use which results in Hematological toxicity.
- •The patient who will understand and follow the instructions and must be able to participate in the study for the entire period.
排除标准
- •Age < 18 years and > 70 years.
- •Patients with WHO performance status grade>
- •Post – op patients adviced to receive adjuvant radiotherapy.
- •Stages IA1 – IB2 and stages IVA-IVB patients.
- •Patients with pelvic and para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis.
- •Patients with deranged liver function test and kidney function test parameters.
- •Severe, active co-morbidity, defined as follows: A.
- •History of Unstable angina and/or congestive heart failure requiring hospitalization within the last 6months.
- •History of myocardial infarction within the last 6 months.
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration to the study.
- •Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
- •Clinical jaundice and/or history of bleeding disorder.
- •Patients who have already received radiation to pelvis and prior history of chemotherapy.
结局指标
主要结局
1) To compare acute hematological, gastro-intestinal and genitourinary toxicities between IMRT (using VMAT technique) and 3DCRT in patients of cervical cancer (FIGO stage IB3-IIIB).
时间窗: 3 months
2) To compare loco-regional response between IMRT (using V-MAT technique) and 3DCRT in cervical cancer (FIGO stage IB3-IIIB).
时间窗: 3 months
次要结局
- 1) To compare overall treatment time during EBRT due to toxicity between IMRT (using VMAT technique) and 3DCRT in cervical cancer (FIGO stage IB3-IIIB).(2) To compare disease free survival between IMRT (using VMAT technique) and 3DCRT in cervical cancer (FIGO stage IB3-IIIB), within the short time span of the study.)