Outcomes of Salvage Chemoradiotherapy followed by brachytherapy in carcinoma cervix patients following inadequate hysterectomy with residual or recurrent disease in a tertiary care oncology centre (SCORE Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
Cervical cancer poses a significant global health issue, particularly in low- and middle-income countries, with 660,301
new cases and 348,874 deaths annually, as per GLOBOCAN 2022. (1) Cervical cancer is the second most common
cancer amongst women in the South East Asian region, and it is a major cause of cancer mortality in low and middle-
income nations. (2) China and India jointly add to more than a third of the worldwide cervical burden, with 48,000
deaths in China and over 60,000 deaths in India alone (3) .
Early cervical cancer is typically asymptomatic, emphasizing the significance of screening. It may be identified in
asymptomatic patients during cancer screening or by chance if a visible lesion is identified during a pelvic
examination (4) . At diagnosis, approximately 44 percent of patients have localized disease, 34 percent have regional disease, and
15 percent have distant metastases (5) .
The majority of cervical malignancies (80-90 percent) are invasive squamous cell tumors, with 10-20 percent being
adenocarcinoma and clear cell cancers constituting 1-2 percent of all cases (6) . Locally Advanced Cervical Cancer (LACC)
is a common presentation in India. LACC can be defined based on FIGO Staging 2018, that include Stage IIb to IIIC1.
The risk of pelvic LN involvement is around 15 percent, 30 percent, and 45 percent for stage I, II, and III illness, respectively.
Treatment outcomes are determined by the stage of the disease at presentation, and the prognosis worsens with an
increasing disease load. Nearly one-third of patients with cervical carcinoma will have a recurrence (7,8) .
Treatment of cervical cancer, in general, depends on the extent of the disease at diagnosis and available local
resources. The treatment may employ radical hysterectomy, chemoradiation, or a combination of both (9) . However,
for LACC, Radiation therapy (RT) has been the main treatment option (10) . Most women with early-stage tumors can
be cured. External beam radiotherapy (EBRT), brachytherapy, and concurrent chemotherapy with cisplatin are used to
treat cervical cancer with curative intent (11) . Several randomized controlled trials (RCTs) and meta-analyses have
shown that concurrent CTRT improves progression-free survival (PFS) and overall survival (OS) (12,13) .
Brachytherapy is an important part of the standard of care for patients receiving radiotherapy for cervical cancer.
Despite the availability of standard treatment options for cervical cancer, challenges persist, particularly with
inappropriate surgery. An inadequate or inadvertent hysterectomy refers to a surgical procedure where the extent of
the surgery is insufficient to remove all cancerous tissue, often due to incorrect preoperative staging or lack of
awareness of the extent of disease spread, lack of expertise and knowledge of oncologic practices. This leads to
residual disease after surgery and disease progression. There is also a significant increase in the risk of recurrence after
inadequate surgery that compromises treatment outcomes. Residual disease and recurrence can result in the need for
additional treatments, such as chemo radiotherapy or brachytherapy, which can impact patient prognosis, quality of
life, and survival.
Despite the established role of concurrent chemoradiotherapy (CTRT) and Brachytherapy in cervical cancer
management, there still remains a paucity of literature specifically addressing their efficacy and optimal utilization in
the context of inappropriate surgery. Studies have focused on definitive treatment settings or adjuvant therapy
following radical surgery, leaving a knowledge gap regarding the nuances of managing patients with a residual or
recurrent disease following inadequate surgery. In this part of the country a large number of cancer cervix patient
present to the oncology centers with residual/recurrent disease following inappropriate surgery.
The present ambispective study that involves radiotherapy with concurrent chemotherapy followed by brachytherapy
is being taken up in patients of cervical cancer with residual and recurrent disease following inappropriate surgery
with an intent to look at patterns of care, survival, and toxicity, that will help establish an evidence-based role of adjuvant therapy, in this group of patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- Female
入选标准
- •Carcinoma of Cervix Uteri with residual and/or recurrent disease following inappropriate surgery.
- •Histopathological proof of Squamous cell carcinoma, adenocarcinoma or adeno-squamous carcinoma.
- •Patients being treated with curative intent using concurrent chemo-radiotherapy (CTRT) followed by brachytherapy.
- •ECOG PS 1-
- •Patient consenting for participation in study (Written informed consent for prospective patients, Telephonic informed consent for retrospective patients).
排除标准
- •Presence of distant metastases.
- •Medical condition precluding curative intent treatment for the patient.
- •History of previous treatment for the present condition.
- •Patients with immunocompromised states and psychological illness.
- •Pregnant or lactating women.
结局指标
主要结局
Disease free survival (DFS)
时间窗: 1 Year
次要结局
- Acute and Late treatment toxicities based on CTCAE v5.0 toxicity criteria(1 Year)
- Overall Survival (OS)(1 Year)
- Radiological response as per RECIST V1.1(6 months)
- Pattern of Failure(1 year)
研究者
Dr SATYAJIT PRADHAN
Mahamana Pandit Madan Mohan Malaviya Cancer Centre Unit of Tata Memorial Centre
