Dose Escalated Radiotherapy and Organ Preservation in Rectal Cancers (DEROP-RC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Rate of complete or near complete clinical response rate of the primary rectal tumors at 12 weeks.
研究概览
简要总结
PrimaryObjective
- Rate of complete or near complete clinical responserate of the primary rectal tumors at 12 weeks.
After pathology confirmed rectal cancer patients with predefinedinclusion criteria will be identified and all patients will be registered inthe study.
Neoadjuvantchemoradiation
All patients will receive neoadjuvant chemoradiotherapy. Radiotherapyto the pelvis will be delivered by 3DCRT or IMRT technique to a dose of45-50Gy/25#/5weeks.
Radiotherapy will be accompanied by Tab Capecitabine (CAPE) 825 mg/ m2 / B.I.D orally during the entire radiotherapy treatment course over 5weeks
Radiotherapy techniques
Modality- All patients will be treated with megavoltagephotons. This includes Cobalt-60 or >4 MV obtained from a linearaccelerator.
Immobilization-Patients may be supine or prone (prone position is recommended,preferably using a belly board).
CT simulation for 3-D planning- CT-based 3-D treatment planningwill be done for all cases.
Evaluationand boost treatment
Within 1 week of completing EBRT (6th-7th week) allpatients will be assessed for radiotherapy boost by digital rectal examination(DRE).
Endorectalbrachyboostwillbe given with high dose rate using Ir192 boost of 4-6Gy/# for 2 # once weekly(2weeks).
For patientsnot fit for endorectalbrachy boost EBRT boost of 9Gy in 4# will be given.
3.4 Evaluation at 6 weekspost Radiotherapy
Response to neoadjuvant treatment will be assessed by DRE, MRI at6-8 weekspost brachytherapy or EBRT (not receiving brachytherapy).If the response is poor after neoadjuvant therapy, patients will undergostandard surgical treatment.For patients who show nCR (near complete response having minimalresidual disease or residual scarring with completeresponse on MRI) or cCR (clinicalcomplete response having no residual disease on DRE and MRI), there will be asecond reassessment at 11-12 weeks after the end of chemoradiotherapy. At theend of this second reassessment, the patient will be offered the rectum-sparingprotocol if it shows nCR or cCR,otherwise it will be a candidate for conventional surgery (TME).
CompleteClinical Response- 1. DRE- Normal
2.Endoscopy- White Scar with telangiectasia without palpable abnormalities
- Absenceof residual tumor on T2W MRI with low signal intensity at the former tumorlocation on DWI-MRI and the absence of suspicious nodes on T2W-MRI.
Near CompleteResponse-1.DRE-Superficial soft irregularity, flat ulcer less than 2 cm at DRE
2.Endoscopy-small residual flat ulcer, or irregular wall thickening.
3. Obvious downstaging with/without residual fibrosis, but with a heterogeneous orirregular aspect on MRI and/or a small focal area of high signal on DWI-MRI
Patients in organpreserving strategy will be subjected to a strict follow up schedule andassessment. The enrolled patients will be assessed 3 monthly by clinical andendoscopic examination and MRI for 2 years thereafter 6 monthly for upto 5years.
Radical TME surgery will be performed inpatients having partial response post8-12 weeks of neoadjuvant treatment. They will undergo regular follow up as perinstitutional protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical Stage T2-T3 -Histologically confirmed diagnosis of adenocarcinoma of the rectum -The distance from anal verge of tumor upto 10 cm(Mid and low rectal tumors) -Palpable upper limit -Involving less than 2/3rd of the circumference -ECOG Performance status 0-1.
排除标准
- •Recurrent rectal cancer -Having pathology of signet ring cell carcinoma -Evidence of distant metastases -Prior pelvic radiotherapy, chemotherapy or surgery for rectal cancer -Creatinine level greater than 1.5 times the upper limit of normal.
- •Patients who are unable to undergo an MRI.
- •Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
- •Patients with a history of any arterial thrombotic event within the past 6 months.
- •This includes angina (stable or unstable), MI, TIA, or CVA.
- •Other Anticancer or Experimental Therapy.
- •Women who are pregnant or breast-feeding.
- •Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
- •Not willing to consent for the study -Unreliable for close follow up.
结局指标
主要结局
Rate of complete or near complete clinical response rate of the primary rectal tumors at 12 weeks.
时间窗: 24 months
次要结局
- -Organ Preservation Rate(-Rate of local regrowth)