Short Course or Long Course Radiotherapy as Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer : A Prospective, Open Label, Single Institution, Randomized, Parallel Arm Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR) rate measured in proportion of participants (%)
研究概览
简要总结
This study compares two standard radiotherapy approaches (short-course vs. long-course) given before surgery in patients with locally advanced rectal cancer. The goal is to see which treatment is more effective and better tolerated.
详细描述
The SHOOL study is a single-institution, open-label, randomized prospective study designed to evaluate and compare two internationally accepted total neoadjuvant therapy (TNT) strategies in patients with locally advanced rectal cancer (LARC). These strategies differ primarily in their radiotherapy schedule and include:
Arm A: Short-course radiotherapy (SCRT; 25 Gy in 5 fractions over 1 week), followed by consolidation chemotherapy and surgery
Arm B: Long-course chemoradiotherapy (LCRT; 50.4 Gy in 28 fractions with concurrent Capecitabine over 5-5.5 weeks), followed by consolidation chemotherapy and surgery The study acronym "SHOOL" reflects the clinical dilemma of whether SHOrt-course Or Long-course radiotherapy offers better or more practical outcomes when delivered within a TNT framework.
This prospective study aims to explore how these two strategies compare in terms of tumour response (as measured by pathological complete response, pCR), toxicity, treatment compliance, feasibility, quality of life, and local recurrence rates at 3 and 5 years. Given that both arms represent evolving standards of care, this study is designed to generate real-world data that can guide institutional decision-making and inform future definitive trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the rectum
- •Locally advanced disease based on MRI including cT3-T4 and/or node positive disease (cN1 or N2)
- •Tumor located within 15 cm from the anal verge (confirmed by endoscopy or MRI)
- •ECOG performance status 0-2
- •Hemoglobin ≥ 9 g/dL
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelets ≥ 100,000/mm³
- •Total bilirubin ≤ 1.5 × ULN
- •Aspartate transaminase/Alanine transaminase ≤ 2.5 × ULN
- •Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min
- •Fit for neoadjuvant therapy and curative resection
- •Willing and able to provide written, informed consent
- •Baseline MRI and biopsy (even if done outside) must be reviewed and approved by the institutional radiology and pathology review board, requiring concurrence from two independent pathologists and two independent radiologists
排除标准
- •Metastatic disease at presentation (distant nodes, liver, lung, peritoneum, etc.)
- •Prior pelvic radiotherapy or systemic chemotherapy for rectal cancer
- •Presence of synchronous malignancies or previous malignancy within 5 years except: Treated basal cell or squamous cell carcinoma of the skin, In situ cervical cancer, Active uncontrolled infection
- •Known HIV infection with CD4 < 200 cells/μL, or active hepatitis B or C
- •Severe comorbid conditions precluding therapy (e.g., decompensated cardiac, hepatic, or renal disease)
- •Pregnant or breastfeeding women
- •Inability to comply with protocol requirements or follow-up schedule
- •Psychiatric illness or social situations that may limit compliance with study requirements
研究组 & 干预措施
SCRT + Consolidation Chemotherapy
Radiotherapy: 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique.
- Interval before Chemotherapy: 1-2 weeks after completion of radiotherapy.
- Chemotherapy: Modified FOLFOX6 every 2 weeks (total of 12 cycles).
干预措施: SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique (Radiation)
LCRT + Consolidation Chemotherapy
Radiotherapy:
- Primary tumor and involved nodes: 50 Gy in 25 fractions.
- Elective nodal basin: 45 Gy in 25 fractions. Delivered concurrently with oral Capecitabine (825 mg/m² twice daily on radiotherapy days).
干预措施: LCRT + Consolidation Chemotherapy (Radiation)
结局指标
主要结局
Pathological complete response (pCR) rate measured in proportion of participants (%)
时间窗: 3 and 5 years
Proportion of participants achieving pathological complete response, defined as ypT0N0 on histopathological examination of resected tumor specimens after surgery. Assessment will be performed by institutional pathologists according to standardized reporting guidelines. The pCR rate is central to evaluating early tumor response to total neoadjuvant therapy. Unit of Measure: Proportion of participants (%)
次要结局
- Acute Toxicities graded using CTCAE version 5.0(3 months post surgery)
- Local Recurrence Rate measured in percentage of participants (%)(3 and 5 years)
- Overall Survival (OS) in months(Evaluated at 3 years and 5 years)
- Late Toxicities documented using clinician assessment and patient reported outcomes EORTC QLQ-C30 and QLQ-CR29(6 months to 2 years post-treatment)
- Treatment completion Rate measured in percentage of participants (%)(1 year)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(1 year)
研究者
Shaifali Goel
Consultant, Department of Gastrointestinal and Hepatobiliary services
Rajiv Gandhi Cancer Institute & Research Center, India