Short Course Radiotherapy And FOLFOX/CAPOX versus mFOLFIRINOX And Long Course Chemoradiation as Total Neoadjuvant Therapy In High-Risk Locally Advanced Rectal Cancers – A Phase III Randomized Control trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 678
- 试验地点
- 1
研究概览
简要总结
The PRAGMATIC TNT Study is a Phase Three randomized clinical trial designed to compare two different total neoadjuvant treatment approaches for patients with high risk, locally advanced rectal cancer. Total neoadjuvant therapy involves giving chemotherapy and radiation therapy before surgery to shrink the tumor and improve outcomes.
In this study, participants are randomly assigned to receive either short course radiotherapy followed by chemotherapy, or chemotherapy followed by long course chemoradiation. After completing the assigned treatment, all patients will undergo surgery to remove the tumor and will be followed for approximately three years.
The primary outcome of the study is event free survival, which measures the time patients remain free from cancer progression or recurrence. The study also aims to assess whether blood based tests can help guide treatment decisions after surgery. By comparing these two treatment strategies, the study seeks to identify the most effective approach and improve long term outcomes for patients with rectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Day(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults of either sex aged more than 18 years who are willing to provide written informed consent.
- •Histologically confirmed rectal adenocarcinoma located within less than 15 centimeters from the anal verge.
- •Eastern Cooperative Oncology Group performance status of 0, 1, or
- •Presence of at least one high-risk feature, including cT3 disease with mesorectal fascia involvement, cT4 disease, extramural vascular invasion, signet ring cell carcinoma or poorly differentiated adenocarcinoma in node-positive or T3 and above disease, or presence of lateral pelvic lymph nodes on pelvic magnetic resonance imaging.
- •Tumors considered resectable or potentially resectable after chemoradiation and patients who are medically fit for surgery.
- •Use of adequate contraception in patients of reproductive potential, with a negative pregnancy test required for women of childbearing potential.
- •Adequate hematological, liver, and renal function at the time of study inclusion.
排除标准
- •Patients meeting any of the following criteria will be excluded from the study: Patients with distant metastases, including para aortic lymph nodes.
- •Para aortic node negativity must be confirmed by radiological or histological assessment before study consideration.
- •Patients suitable for a PROSPECT type neoadjuvant approach, including upper or mid rectal T3 tumors without mesorectal fascia involvement, limited nodal disease, no lateral pelvic nodes, and no extramural vascular invasion.
- •Patients with signet ring rectal adenocarcinoma staged as T3 N0 without extramural vascular invasion or lateral pelvic lymph nodes.
- •Patients with low rectal adenocarcinoma who are candidates for intersphincteric resection or non operative management such as a wait and watch approach, as determined by the multidisciplinary team prior to screening.
- •Patients with microsatellite instability high tumors.
- •Patients with rectal cancer histology other than adenocarcinoma.
- •Patients with a history of coronary artery disease, including angina or myocardial infarction.
- •Patients with known homozygous dihydropyrimidine dehydrogenase deficiency.
- •Patients with grade two or higher sensory or motor neuropathy.
- •Patients with known hypersensitivity or contraindications to any study related medication.
- •Patients with another active malignancy or a past history of malignancy, except for treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- •Patients with human immunodeficiency virus, hepatitis B, or hepatitis C infection requiring active antiviral therapy at screening.
- •Pregnant or breastfeeding women.
- •Patients with active progressive infection or any other serious medical condition that may interfere with study treatment.
研究者
Dr Anant Ramaswamy
Tata Memorial Hospital