2024-516106-31-00招募中3 期
STAR-TREC: Can we Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early REctal Cancer?
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 21
- 主要终点
- Phase II: The primary endpoint of the STAR-TREC feasibility study is - Recruitment rate measured at 12 and 24 months.
研究概览
简要总结
The phase II component will assess the feasibility of a large, multi-centre randomised trial comparing radical surgery versus organ saving treatment using (chemo)radiotherapy followed by selective transanal microsurgery.
The STAR-TREC phase III study will evaluate whether a CRT or SCRT organ preservation strategy leads to higher organ preservation rates and should become first line treatment for early rectal cancer. This objective can be divided into two main questions: a) Determine the optimal radiation schedule to achieve the highest rate of organ preservation b) Determine the optimal radiation schedule to achieve the best quality of life after organ preservation
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven adenocarcinoma of the rectum
- •Magnetic Resonance Imaging (MRI)- or Endorectal Ultrasound (ERUS)-staged TX/T1-3b, NX/N0, MX/M0 rectal tumour
- •MDT determines that the following treatment options are all reasonable and feasible: (a) TME surgery, (b) CRT, (c) SCRT and (d) Transanal Endoscopic Microsurgery (TEM)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Willing and able to consent
排除标准
- •Concomitant or previous malignancies within 3 years prior to trial entry, except those that in the opinion of the MDT are unlikely to relapse within 3 years or lead to death within 5 years
- •Definite evidence of regional or distant metastases (M1) in opinion of MDT
- •Uncontrolled cardiorespiratory comorbidity (inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to trial entry)
- •Known complete Dihydropyrimidine Dehydrogenase deficiency
- •Known Gilbert’s disease
- •Taking coumarin-derivative oral anticoagulants that cannot be stopped or substituted by low molecular weight heparin
- •Taking metronidazole, phenytoin, sorivudine or its analogues, such as brivudine
- •Women who are pregnant or lactating
- •Age <16 years (UK), <18 years (other countries)
- •MRI node positive (≥N1, defined by protocol guidelines)
- •MRI extramural vascular invasion (mriEMVI) present (defined by protocol guidelines)
- •MRI defined mucinous tumour
- •Mesorectal fascia threatened by tumour (≤ 1mm on MRI or ERUS)
- •Maximum tumour diameter >40mm (either measured from everted edges on sagittal MRI or ERUS examination)
- •Anterior tumour location above the peritoneal reflection on MRI or ERUS
- •No residual luminal tumour following endoscopic mucosal resection
- •Prior pelvic radiotherapy
结局指标
主要结局
Phase II: The primary endpoint of the STAR-TREC feasibility study is - Recruitment rate measured at 12 and 24 months.
Phase II: The primary endpoint of the STAR-TREC feasibility study is - Recruitment rate measured at 12 and 24 months.
Phase III: The primary endpoint of the STAR-TREC phase III study is the proportion of patients with successful organ preservation at 30 months from the start day of (chemo)radiotherapy treatment.
Phase III: The primary endpoint of the STAR-TREC phase III study is the proportion of patients with successful organ preservation at 30 months from the start day of (chemo)radiotherapy treatment.
次要结局
- A) Secondary outcomes for the randomised comparison between organ-preserving strategies:
- * Clinician-reported acute treatment-related toxicity up to 30 days following completion of (chemo)radiotherapy
- * Proportion of patients with complete response to (chemo)radiation therapy
- * Proportion of patients undergoing transanal local excision
- * Time to event of organ loss assessed for patients who prefer organ preservation; defined as the length of time from the start date of trial treatment until TME surgery
- * Non-regrowth pelvic tumour control to 36 months; defined as the length of time from the start date of trial treatment until death (any cause) or development of unequivocal pelvic recurrence but not including patients who developed local regrowth which was resected with clear margins using standard TME surgery
- * Metastasis-free survival to 36 months; defined as the length of time from the start date of trial treatment until death (any cause) or detection of distant metastasis
- * Non-regrowth -disease free survival to 36 months; defined as the length of time from the start of trial treatment until death (any cause), detection of local pelvic recurrence or distant metastasis but not including patients who developed local regrowth which was resected with clear margins using standard TME surgery
- * Overall survival to 60 months; defined as the length of time from the start date of trial treatment until death (any cause)
- B) Secondary endpoints for analyses incorporating the standard surgery comparator (phase II: randomised comparison; phase III: non-randomised comparison):
- * Clinician-reported acute treatment related toxicity up to 30 days following completion of (chemo)radiotherapy or date of initial surgery
- * Non-regrowth pelvic tumour control to 36 months; defined as the length of time from the start date of trial treatment or date of initial surgery until death (any cause) or development of unequivocal pelvic recurrence but not including patients who preferred organ preservation and developed local regrowth which was resected with clear margins using standard TME surgery
- * Metastasis-free survival to 36 months; defined as the length of time from the start date of trial treatment or date of initial surgery until death (any cause) or detection of distant metastasis
- * Disease-free survival to 36 months; defined as the length of time from the start date of trial treatment or date of initial surgery until death (any cause), detection of local pelvic recurrence or distant metastasis but not including patients who developed local regrowth which was resected with clear margins using standard TME surgery
- * Overall survival to 60 months; defined as the length of time from the start date of trial treatment or date of initial surgery until death (any cause)
- * Decision regret at 24 months measured using the validated Decision regret scale questionnaire
- C) Secondary endpoints for analyses of patient-reported outcomes
- * Symptomatic toxicity, health economics and HRQoL measured at 3, 12, 24 and 36 months compared to baseline using validated questionnaires (HRQoL booklet) This analysis will be conducted incorporating the following comparisons:
- a. Randomised comparison between organ-preserving strategies
- b. Randomised (phase II data) and non-randomised (phase III data) comparisons between organ preserving strategies and the standard surgery comparator
研究者
Clinical Trial Coordinator
Scientific
The University Of Birmingham
研究点 (21)
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