NCT06563388招募中3 期
(ID-COMET) A Randomized Phase III Trial of Immediate Versus Six-Month Delayed Comprehensive Treatment of 1-10 Oligometastatic Tumors With or Without Synchronous Primary
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Overall Survival - Trial 1 and 2
研究概览
简要总结
This protocol is comprised of three unblinded, randomized, single-center studies to evaluate the impact of immediate versus three-month delayed comprehensive ablative treatment on survival in newly diagnosed metastatic patients with lung (Trial 1), colorectal (Trial 2), and prostate (Trial 3) cancers
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 year or older.
- •Willing to provide informed consent.
- •Life expectancy > 6 months.
- •Trials 1-3: Histologically confirmed lung, prostate or colorectal malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
- •Trial 4: Any malignancy with metastasis. Participants with liquid tumors are eligible provided they have biopsy confirmed refractory disease and are eligible for salvage radiotherapy.
- •Newly diagnosed metastatic (1-10 sites)patients for Trials 1-
- •Previously diagnosed metastatic patients (1-10 sites or oligoprogression in 5 or fewer sites with no limit on total number for Trial
- •Restaging completed within 12 (+/- 4) weeks prior to randomization.
- •For patients receiving thoracic radiotherapy, the enrolling physician must confirm there are no computed tomography (CT) changes suggestive of fibrotic interstitial lung disease (ILD) (i.e., reticular changes, traction bronchiectasis, or honeycombing) reported on any prior CT scans. If any are present, the patient must be assessed by a respirologist to rule out ILD prior to enrollment.
- •Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry.
- •Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- •Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
排除标准
- •. Participants who have no option for standard systemic therapy or refuse systemic therapy.
- •Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
- •Serious medical comorbidities precluding radiotherapy. These include ILD in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.
- •For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C); please see the Child-Pugh score calculator.
- •Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix E. All such cases must be discussed with the PI or Co-I .
- •Malignant pleural effusion.
- •Inability to treat all sites of disease.
- •Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel) or skin.
- •Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •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 or nursing female participants.
研究组 & 干预措施
SABR plus Standard therapy - Trial 1-3 Arm 2
Experimental
干预措施: Best Practice (Other)
Standard Therapy followed by SABR - Trial 1-3 Arm 1
Experimental
干预措施: Stereotactic Ablative Radiotherapy (Procedure)
Standard Therapy followed by SABR - Trial 1-3 Arm 1
Experimental
干预措施: Best Practice (Other)
SABR plus Standard therapy - Trial 1-3 Arm 2
Experimental
干预措施: Stereotactic Ablative Radiotherapy (Procedure)
Trial 4 - Immediate SABR plus standard of care
Experimental
干预措施: Stereotactic Ablative Radiotherapy (Procedure)
Trial 4 - Immediate SABR plus standard of care
Experimental
干预措施: Best Practice (Other)
结局指标
主要结局
Overall Survival - Trial 1 and 2
时间窗: UP to 5 years
Calculated from the time of randomization until death
Androgen DeprivationTherapy (ADT)-free survival - Trial 3
时间窗: Up to 5 years
The time from radomization until receipt of ADT, death due to any cause, end of study or last follow up.
次要结局
- Change in Quality of Life(Up to 5 years after radiation treatment)
- Physician determined Radiation related toxicity(5 years)
研究者
研究点 (1)
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