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临床试验/CTRI/2025/08/093607
CTRI/2025/08/093607尚未招募不适用

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)

Homi Bhabha Cancer Hospital & Mahamana Pandit Madan Mohan Malaviya Cancer Centre1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月3日最近更新:

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

发起方
Homi Bhabha Cancer Hospital & Mahamana Pandit Madan Mohan Malaviya Cancer Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr SATYAJIT PRADHAN

Mahamana Pandit Madan Mohan Malaviya Cancer Centre Unit of Tata Memorial Centre

研究点 (1)

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