NCT05174169ClinicalTrials.gov
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
باختصار
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
المرحلة 2 / المرحلة 3مطلوب 1,912 مشاركاً1,077 موقعاً3 دول
الفئات
مسجَّلة في سجل واحد
- ClinicalTrials.govNCT05174169فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل 3 أسابيع
يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.
تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.
هل أنت مهتم بهذه الدراسة؟
تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.
How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2021-12-30; recorded start 2022-07-08
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Not stated: Open label (no blinding)Masking is recorded as none (open label)
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 49 other studies in this databaseCounted from the lead sponsor named in the record (NRG Oncology)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 1 condition.
- Lead sponsor type recorded as: other.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation20/20
Participants are randomly allocated between arms
- Blinding0/20
Open-label
- Control arm15/15
Active-comparator control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre8/8
Multi-centre: 1063 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A large study, international in scope: 1,912 participants (target), run at 1,077 sites, across 3 countries.
How this score is built
- Enrolment33/40
1,912 participants (target)
- Site count25/25
1,063 sites
- Country count7/15
3 countries
- Planned duration10/10
Planned over about 93 months
- Sponsor scale6/10
NRG Oncology has led 49 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
ملخص
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
الحالات
- Stage III Colon Cancer
الأهلية
| الجنس | الجميع |
|---|---|
| الأعمار | 18 Years – لا حد أقصى |
| المتطوعون الأصحّاء | لا |
الأهلية كما كُتبت في السجل
الأهلية في عبارات بسيطة
لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.
تصميم الدراسة
| نوع الدراسة | تدخّلية |
|---|---|
| المرحلة | المرحلة 2 / المرحلة 3 |
| التخصيص | معشّاة |
| نموذج التدخّل | PARALLEL |
| الغرض الأساسي | TREATMENT |
| التعمية | NONE (0) |
| التجنيد | مطلوب 1,912 مشاركاً |
الجهة الراعية والمتعاونون
- NRG Oncology الجهة الراعية
- Natera, Inc. المتعاونون
- National Cancer Institute (NCI) المتعاونون
الأذرع والتدخلات
- Cohort A - Arm 1 (ctDNA-ve)ACTIVE_COMPARATOR
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 6-12 cycles OR Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 4 cycles
- Cohort A - Arm 2 (ctDNA-ve)EXPERIMENTAL
Serial ctDNA monitoring no treatment
- Cohort B - Arm 3 (ctDNA+ve)ACTIVE_COMPARATOR
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles OR Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 8 cycles
- Cohort B - Arm 4 (ctDNA+ve)EXPERIMENTAL
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + Irinotecan 150 mg/m2 IV continuous infusion (30-90 minutes) + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles
التدخلات
- دواء CAPOX 3 month
Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 4 cycles
- دواء CAPOX 6 month
Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 8 cycles
- جهاز Signatera test
Central ctDNA testing for all patients
- دواء mFOLFIRINOX
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + Irinotecan 150 mg/m2 IV continuous infusion (30-90 minutes) + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles
- دواء mFOLFOX6 3-6 month
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 6-12 cycles
- دواء mFOLFOX6 6 month
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles
مقاييس النتائج
مقياس النتيجة الأولي
ctDNA positive status (TTPos)
TTPos is defined as time from randomization until ctDNA positive event: TTPos events are first ctDNA positive result after randomization for the immediate adjuvant chemo arm (Arm 1), 2nd ctDNA positive result after randomization for the delayed adjuvant chemo (Arm 2) and recurrence without a positive ctDNA result for both arms.
الإطار الزمني Time from randomization to the first TTPos event, a maximum of 3 years
مقياس النتيجة الأولي
Disease-Free Survival (DFS)
Time from randomization to first disease-free survival event (recurrence, second primary colorectal cancer or death from any cause).
الإطار الزمني Time from randomization to disease-free survival event, a maximum of 5 years]
مقياس النتيجة الثانوي
Baseline post-surgery ctDNA positivity rate
percentage of patients with ctDNA positive results post-surgery at study entry.
الإطار الزمني At time of randomization
مقياس النتيجة الثانوي
Overall Survival (OS)
Time from randomization to death of any cause.
الإطار الزمني Time from randomization to death, a maximum of 5 years.
مقياس النتيجة الثانوي
Recurrence
Time from randomization to disease recurrence.
الإطار الزمني Time from randomization to disease recurrence, a maximum of 5 years
مقياس النتيجة الثانوي
Compliance with adjuvant chemotherapy
number of cycles of chemotherapy received.
الإطار الزمني from randomization to the last cycle of chemotherapy, a maximum of 6 months.
التواريخ
| تاريخ البدء | 8 يوليو 2022 (فعلي) |
|---|---|
| الإتمام الأولي | 10 مارس 2029 (تقديري) |
| الإتمام | 10 مارس 2030 (تقديري) |
| أول نشر | 30 ديسمبر 2021 (فعلي) |
| آخر تحديث | 2 سبتمبر 2026 |
| النتائج منشورة | غير مذكور في سجل السجل |
| آخر تأكيد للحالة | سبتمبر 2026 |
فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.
المواقع
964 موقعاً قيد التجنيد
Canada
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Royal Victoria Regional Health Centre | Barrie | Ontario | قيد التجنيد |
| Arthur J E Child Comprehensive Cancer Centre | Calgary | Alberta | قيد التجنيد |
| Cambridge Memorial Hospital | Cambridge | Ontario | قيد التجنيد |
| CSSS Champlain-Charles Le Moyne | Greenfield Park | Quebec | قيد التجنيد |
| Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario | قيد التجنيد |
| Kingston Health Sciences Centre | Kingston | Ontario | قيد التجنيد |
| Waterloo Regional Health Network | Kitchener | Ontario | قيد التجنيد |
| London Regional Cancer Program | London | Ontario | قيد التجنيد |
| Hotel-Dieu De Levis | Lévis | Quebec | قيد التجنيد |
| Markham Stouffville Hospital | Markham | Ontario | قيد التجنيد |
| Jewish General Hospital | Montreal | Quebec | قيد التجنيد |
| Hopital Du Sacre-Coeur de Montreal | Montreal | Quebec | قيد التجنيد |
| CIUSSSEMTL-Hopital Maisonneuve-Rosemont | Montreal | Quebec | قيد التجنيد |
| Stronach Regional Health Centre at Southlake | Newmarket | Ontario | قيد التجنيد |
| Lakeridge Health Oshawa | Oshawa | Ontario | قيد التجنيد |
| Ottawa Hospital and Cancer Center-General Campus | Ottawa | Ontario | قيد التجنيد |
| BCCA-Cancer Centre for the North | Prince George | British Columbia | قيد التجنيد |
| CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) | Québec | Quebec | قيد التجنيد |
| Allan Blair Cancer Centre | Regina | Saskatchewan | قيد التجنيد |
| Niagara Health System-Saint Catharines General | Saint Catharines | Ontario | قيد التجنيد |
| Atlantic Health Sciences Corporation-Saint John Regional Hospital | Saint John | New Brunswick | قيد التجنيد |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | قيد التجنيد |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont | Sherbrooke | Quebec | قيد التجنيد |
| Doctor H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | قيد التجنيد |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre | Toronto | Ontario | قيد التجنيد |
| Humber River Hospital | Toronto | Ontario | قيد التجنيد |
| North York General Hospital | Toronto | Ontario | قيد التجنيد |
| Saint Michael's Hospital | Toronto | Ontario | قيد التجنيد |
| BCCA-Vancouver Cancer Centre | Vancouver | British Columbia | قيد التجنيد |
| BCCA-Vancouver Island Cancer Centre | Victoria | British Columbia | قيد التجنيد |
| Windsor Regional Cancer Centre | Windsor | Ontario | مُعلَّق |
Puerto Rico
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Pan American Center for Oncology Trials LLC - Cayey | Cayey | قيد التجنيد | |
| Pan American Center for Oncology Trials LLC - Dorado | Dorado | قيد التجنيد | |
| Doctors Cancer Center | Manati | قيد التجنيد | |
| Pan American Center for Oncology Trials LLC | San Juan | قيد التجنيد | |
| Pan American Center for Oncology Trials LLC - Mayaguez | San Juan | PR | قيد التجنيد |
| Centro Comprensivo de Cancer de UPR | San Juan | قيد التجنيد | |
| PROncology | San Juan | قيد التجنيد | |
| San Juan City Hospital | San Juan | قيد التجنيد | |
| Pan American Center for Oncology Trials LLC - Ciudadela | San Juan | قيد التجنيد |
United States
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Abbeville General Hospital | Abbeville | Louisiana | قيد التجنيد |
| UM Upper Chesapeake Hematology and Oncology - Aberdeen | Aberdeen | Maryland | قيد التجنيد |
| Avera Cancer Institute-Aberdeen | Aberdeen | South Dakota | قيد التجنيد |
| Cleveland Clinic Akron General | Akron | Ohio | قيد التجنيد |
| Summa Health System - Akron Campus | Akron | Ohio | قيد التجنيد |
| Phoebe Putney Memorial Hospital | Albany | Georgia | قيد التجنيد |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | قيد التجنيد |
| Presbyterian Kaseman Hospital | Albuquerque | New Mexico | قيد التجنيد |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | قيد التجنيد |
| Aultman Alliance Community Hospital | Alliance | Ohio | قيد التجنيد |
يُدرَج 1,027 موقعاً إضافياً في سجل السجل.
مستندات الدراسة
لا تُرتبط أي مستندات في سجل السجل هذا.
التغيّرات عبر الزمن
- 2 سبتمبر 2026
أُضيف موقع
11 sites added (1077 total)
10661077
- 4 أغسطس 2026
أُضيف موقع
3 sites added (1066 total)
10631066