NCT02641691已完成2 期
Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum (NORMAL-R)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete Response Rate
研究概览
简要总结
The purpose of this research study is to look at how tumors responds to a short course of radiation (5 days) followed by 8 cycles of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-1, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI and/or endorectal ultrasound
- •Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy a
- •ECOG performance status 0-2
- •At least 18 years of age
- •Adequate bone marrow function defined as:
- •ANC > 1,500 cells/mm3
- •Hgb > 8 g/dl
- •platelets >100,000 cells/mm3
- •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- •Able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- •No clinically detectable (MR, endoscopy or DRE) tumor present
- •Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer.
- •Any evidence of disease from another malignancy or history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix). Patients with history of prostate cancer treated without radiotherapy and no evidence of disease are eligible.
- •Currently receiving any investigational agents.
- •A history of allergic reaction attributed to compounds of similar chemical or biologic composition to 5FU, oxaliplatin, or leucovorin.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
- •Known HIV-positivity and on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study drugs. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
研究组 & 干预措施
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
Experimental
- Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
- An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
- Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
- Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
- Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
- 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
- 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
- Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
干预措施: Radiation (Radiation)
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
Experimental
- Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
- An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
- Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
- Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
- Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
- 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
- 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
- Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
干预措施: Oxaliplatin (Drug)
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
Experimental
- Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
- An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
- Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
- Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
- Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
- 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
- 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
- Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
干预措施: Leucovorin (Drug)
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
Experimental
- Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
- An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
- Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
- Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
- Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
- 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
- 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
- Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
干预措施: Fluorouracil (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: 1 year
* Criteria for complete clinical response: * No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer * No radiographic evidence of tumor on DRE * Substantial downsizing on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment) * Criteria for no significant clinical response: * Residual disease by DRE, endoscopy or MR. * Increase in primary tumor size upon clinical exam or imaging * Any new lesions
次要结局
- Number of Any Grade 3 or Higher Toxicities(From start of radiation treatment through 30 days after completion of treatment (approximately 18 weeks))
- Number of Post Chemotherapy Grade 3 or Higher Toxicities(Post-chemotherapy through 1 year follow-up (approximately 1 year and 4 months))
- Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire(10-14 months after chemoradiation (approximately 16-20 months))
- Quality of Anorectal Function as Measured by the FACT-C Questionnaire(10-14 months after chemoradiation (approximately 16-20 months))
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
A Randomized Study of Primary Tumor Radiotherapy for Patients With Stage Ⅳ NSCLCRadiotherapyNonsmall Cell Lung Cancer, Stage IVNCT04654520Guizhou Medical University290
招募中
2 期
The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal AdenocarcinomaRectal AdenocarcinomaNCT06266832Sir Run Run Shaw Hospital30
终止
2 期
Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk OsteosarcomaMetastatic OsteosarcomaNCT01886105Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins4
撤回
2 期
Efficacy of Radiation Therapy and Transarterial Chemoembolization (TACE) to Treat Hepatocellular Carcinoma (HCC)Hepatocellular CarcinomaNCT01432314Asan Medical Center
终止
不适用
Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung CancerNon Small Cell Lung CancerNCT01647334London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's29