A Prospective Study to determine feasibility, Tolerability and efficacy of ultrafractionation along with Induction chemotherapy followed by Concurrent chemoradiotherapy compared to standard Concurrent Chemo-radiotherapy in patients of Locally advanced Squamous cell Carcinoma Cervix
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Cervical cancer is a significant global health burden and remains one of the leading causes of cancer-related deaths among women, especially in low- and middle-income countries.
The standard of care for patients with locally advanced cervical cancer has remained largely unchanged since the National Cancer Institute alert in the 1990s. Although concurrent chemoradiotherapy has significantly improved locoregional control and overall survival compared with radiotherapy alone, treatment failure due to distant metastases still occurs in approximately 30.00 to 35.00 per cent of patients.
Recently, the INTERLACE trial, an international phase III randomized study, demonstrated that short-course weekly induction chemotherapy with paclitaxel and carboplatin followed by chemoradiotherapy significantly improves progression-free survival and overall survival in women with locally advanced cervical cancer compared with chemoradiotherapy alone.
Preclinical and clinical evidence suggest that in rapidly proliferating tumors such as those of the head and neck region and carcinoma of the cervix, adding small doses of Ultrafractionated radiotherapy to chemotherapy enhances chemosensitivity. This occurs through modulation of the homologous recombination repair and ionizing radiation response pathways, thereby preventing tumor repopulation
The present study proposes to explore Short Induction chemotherapy with Ultrafractionated Low dose radiotherapy prior to definitive concurrent chemoradiotherapy.
The Present Trial Protocl proposes to compare the results of addition of two cycles of Induction Chemotherapy with Paclitaxel(175 mg/ m2) and Carboplatin (5AUC) day 1 Q 21 days with Low dose ultrafractionated Radiotherapy ( 80 cGy / fraction , 2 fractions a day, at least 6 hrs apart on the day of induction chemotherapy and the next day) to Standard Concurrent Chemo-Radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Participants must fulfill all of the following criteria to be eligible for the study: Histopathological confirmation: Carcinoma Cervix (Squamous Cell Carcinoma).
- •Age: 18.00 years (equivalent to 6,570 days) to 65.00 years (equivalent to 23,725.00 days).
- •Sex: Female.
- •Baseline Hematologic Parameters: a.
- •Hemoglobin greater than or equal to 10.00 grams per deciliter.
- •Total Leukocyte Count greater than or equal to 1,500.00 cells per cubic millimeter.
- •Platelet Count greater than or equal to 100,000.00 per cubic millimeter.
- •Stage of Disease: FIGO Stage IIB, III, or IVA.
- •Liver Function Tests: a.
- •Total Bilirubin less than or equal to 2.00 times the upper normal limit.
- •SGOT and SGPT less than or equal to 3.00 times the upper normal limit.
- •Renal Function: a.
- •Estimated Creatinine Clearance greater than or equal to 50.00 milliliters per minute, calculated using the Cockcroft-Gault or MDRD formula.
排除标准
- •Participants will be excluded from the study if they meet any of the following criteria: Presence of any other solid tumor within the past five years except skin melanoma treated with local therapy only.
- •Prior pelvic radiotherapy for any indication.
- •Presence of vesicovaginal fistula or rectovaginal fistula at presentation, either radiologically or clinically.
- •History of or current uncontrolled co-morbid conditions which, in the opinion of the investigator, would compromise the safety of the patient.
- •Known contraindications to radiotherapy.
- •Any disease where para-aortic nodal irradiation is considered the standard of care.
- •Known allergies or hypersensitivity reactions to platinum-based drugs, taxanes, arachis oil, or any other drugs to be administered in the study protocol schedule.
- •Pregnant or lactating women.
- •Patients unable to provide informed consent or comply with the follow-up protocol.
研究者
Younus Mondal
Institute of Post Graduate Medical Education and Research Kolkata