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临床试验/CTRI/2026/01/100828
CTRI/2026/01/100828尚未招募不适用

A Study on Clinical Outcome with Induction Chemotherapy Followed by Concurrent Chemoradiation in Locally Advanced Cervical Cancer in A Tertiary Care Centre

Dr Piyush Ranjan Sahoo1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2026年1月27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
54
试验地点
1

研究概览

简要总结

Cervical cancer remains a major health burden, with most women in low- and middle-income countries presenting with locally advanced cervical cancer (LACC). The current standard of care is concurrent chemoradiation (CCRT) with weekly cisplatin and brachytherapy, although distant metastases and treatment failure remain significant challenges.

Induction (neoadjuvant) chemotherapy (NACT) has recently been explored as a strategy to reduce systemic relapse, but prolonged overall treatment time (OTT) in earlier studies, particularly durations beyond 56 days, is known to be associated with inferior outcomes.

The phase III INTERLACE trial evaluated a short, six-week induction regimen with weekly carboplatin–paclitaxel prior to standard CCRT. The study demonstrated significant improvements in both progression-free survival (72% vs 64%) and overall survival (80% vs 72%) at five years, while maintaining acceptable OTT. These results suggest that NACT, if delivered without delaying definitive therapy, may enhance systemic control and survival in LACC.

Our study aims to conduct an analysis of induction chemotherapy followed by CCRT in patients with LACC with respect to clinical outcomes, real-world feasibility, and the impact on treatment compliance and toxicity. Such evidence will be critical in determining whether NACT should be adopted as part of standard management for LACC.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

  • Histopathology-confirmed FIGO 2018 stage IB2-IVA squamous, adenosquamous or adenocarcinoma of the cervix.
  • Medically fit to receive carboplatin and paclitaxel.
  • ECOG performance status 0 – 2
  • Aged 18 and over
  • Adequate renal function (defined as a GFR 60 ml per min or more using the Wright equation), liver function, and hematological profile.

排除标准

  • Previous pelvic radiotherapy.
  • Recurrent or metastatic disease at diagnosis.
  • Pregnancy or lactation.
  • Other synchronous malignancy.
  • Hydronephrosis, unless relieved by stenting or nephrostomy.
  • Patients who did not consent.

研究者

发起方
Dr Piyush Ranjan Sahoo
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Piyush Ranjan Sahoo

Institute of Medical sciences and SUM Hospital

研究点 (1)

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