NCT05174169ClinicalTrials.gov

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

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En resumen

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.

Fase 2 / Fase 31912 participantes buscados1077 centros3 países

Categorías

Oncología84%Gastroenterología y hepatología16%

Registrado en 1 registro

ClinicalTrials.govNCT05174169Abrir este registro en ClinicalTrials.govSincronizado hace 3 semanas

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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.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

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.

Methodological rigourSTRONG

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

ScaleLARGE

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

Investigator standingUNKNOWN

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.

Resumen

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.

Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer to determine need for adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) shed into the bloodstream represents a highly specific and sensitive approach (especially with serial monitoring) for identifying microscopic or residual tumor cells in colon cancer patients and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. Colon cancer patients who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may not need adjuvant chemotherapy. Furthermore, for colon cancer pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal adjuvant chemotherapy regimen has not been established. We hypothesize that for pts whose colon cancer has been resected, ctDNA status may be used to risk stratify for making decisions about adjuvant chemotherapy.

Afecciones

Stage III Colon Cancer

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – Sin máximo
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

Inclusion Criteria: The patient must have an ECOG performance status of 0 or 1. Patients must have histologically/pathologically confirmed Stage IIB, IIC, or Stage III colon adenocarcinoma with R0 resection according to AJCC 8th edition criteria. No radiographic evidence of overt metastatic disease within 45 days prior to Step 1/Study entry (CT with IV contrast or MRI imaging is acceptable and must include chest, abdomen, and pelvis). The distal extent of the tumor must be greater than or equal to 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation). The patient must have had an en bloc complete gross resection of tumor (curative resection). Patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible. The resected tumor specimen and a blood specimen from patients with Stage IIB, IIC, or Stage III colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera (after Step 1/Study entry and before Step2/Randomization). Patient must have sufficient tissue to meet protocol requirements. This blood specimen for the Signatera assay must be collected after surgery (and recommended at least 14 days post surgery). Tumor must be documented as microsatellite stable or have intact mismatch repair proteins through CLIA-approved laboratory testing. Patients whose tumors are MSI-H or dMMR are excluded. The treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan). The interval between surgery (post-operative Day 7) and Step 1/Study entry must be no more than 60 days. NOTE: Step 1/Study Entry may occur as early as post operative Day 7, but it cannot occur beyond 60 days from the actual date of the patient's surgery. Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling. Adequate hematologic function within 28 days before Step 1/Study entry defined as follows: * Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; * Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible. * BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups. * Platelet count must be greater than or equal to 100,000/mm3; and * Hemoglobin must be greater than or equal to 9 g/dL. Adequate hepatic function within 28 days before Step 1/Study entry defined as follows: * total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and * alkaline phosphatase must be less than 2.5 x ULN for the lab; and * AST and ALT must be less than 2.5 x ULN for the lab. Adequate renal function within 28 days before Step 1/Study entry defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab. For Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL) NOTE: Adjusted body weight (AdjBW) should be used for patients that have BMI greater than or equal to 28 (less than or equal to 30% above IBW). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Pregnancy test (urine or serum according to institutional standard) done within 14 days before Step 1/Study entry must be negative (for women of childbearing potential only). Patients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of INR if they are randomized to Arm 1 or Arm 3 and receive capecitabine. Eligibility Criteria for Cohort A Arm-2 patients on Second Randomization Patient must have developed a ctDNA +ve assay during serial monitoring. Patient's willingness to be re-randomized affirmed. The patient must continue to have an ECOG performance status of 0 or 1. No radiographic evidence of overt metastatic disease. Pregnancy test (urine or serum according to institutional standard) done within 14 days before second randomization must be negative (for women of childbearing potential only). Adequate hematologic function within 28 days before second randomization defined as follows: * Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; * Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible. * BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups. * Platelet count must be greater than or equal to 100,000/mm3; and * Hemoglobin must be greater than or equal to 9 g/dL. Adequate hepatic function within 28 days before second randomization defined as follows: * total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and * alkaline phosphatase must be less than 2.5 x ULN for the lab; and * AST and ALT must be less than 2.5 x ULN for the lab. Adequate renal function within 28 days before second randomization defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab. For Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL) Exclusion Criteria: Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.). Pathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected. Tumor-related bowel perforation. History of prior invasive colon malignancy, regardless of disease-free interval. History of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ/tissue donation are not exclusionary. Any prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary colon adenocarcinomas for which treatment with neoadjuvant chemotherapy and/or radiation is warranted are not permitted). EXCEPTION: one cycle of chemotherapy (regimen per treating physicians' discretion - 5-FU or capecitabine with or without oxaliplatin) is allowed but not required after consent. The optional cycle of chemotherapy should be started greater than or equal to 4 weeks from surgery and while awaiting Step 2 randomization. Other invasive malignancy within 5 years before Step 1/Study entry. Exceptions are colonic polyps, non-melanoma skin cancer or any carcinoma-in-situ. Synchronous primary rectal and/ or colon cancers. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Sensory or motor neuropathy greater than or equal to grade 2, according to CTCAE v5.0. Blood transfusion within two weeks before collection of blood for central ctDNA testing. Active seizure disorder uncontrolled by medication. Active or chronic infection requiring systemic therapy. Known homozygous DPD (dihydropyrimidine dehydrogenase) deficiency. Patients known to have Gilbert's Syndrome or homozygosity for UGT1A1\*28 polymorphism. Pregnancy or lactation at the time of Step 1/Study entry. Co-morbid illnesses or other concurrent disease that would make the patient inappropriate for entry into this study (i.e., unable to tolerate 6 months of combination chemotherapy or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up). Ineligibility Criteria for Cohort A Arm-2 patients on Second Randomization Pregnancy or lactation at the time of randomization. No longer a candidate for systemic chemotherapy (FOLFOX, CAPOX, and mFOLFIRINOX) in the opinion of the treating investigator.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 2 / Fase 3
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	NONE (0)
Inscripción	1912 participantes buscados

Patrocinador y colaboradores

NRG Oncology Patrocinador
Natera, Inc. Colaboradores
National Cancer Institute (NCI) Colaboradores

Grupos e intervenciones

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

Intervenciones

Fármaco 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
Fármaco 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
Dispositivo Signatera test
Central ctDNA testing for all patients
Fármaco 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
Fármaco 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
Fármaco 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

Variables de resultado

Variable de resultado principal
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.
Plazo Time from randomization to the first TTPos event, a maximum of 3 years
Variable de resultado principal
Disease-Free Survival (DFS)
Time from randomization to first disease-free survival event (recurrence, second primary colorectal cancer or death from any cause).
Plazo Time from randomization to disease-free survival event, a maximum of 5 years]
Variable de resultado secundaria
Baseline post-surgery ctDNA positivity rate
percentage of patients with ctDNA positive results post-surgery at study entry.
Plazo At time of randomization
Variable de resultado secundaria
Overall Survival (OS)
Time from randomization to death of any cause.
Plazo Time from randomization to death, a maximum of 5 years.
Variable de resultado secundaria
Recurrence
Time from randomization to disease recurrence.
Plazo Time from randomization to disease recurrence, a maximum of 5 years
Variable de resultado secundaria
Compliance with adjuvant chemotherapy
number of cycles of chemotherapy received.
Plazo from randomization to the last cycle of chemotherapy, a maximum of 6 months.

Fechas

Fechas
Fecha de inicio	8 de julio de 2022 (real)
Finalización principal	10 de marzo de 2029 (estimada)
Finalización	10 de marzo de 2030 (estimada)
Primera publicación	30 de diciembre de 2021 (real)
Última actualización	2 de septiembre de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	septiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

964 centros están en reclutamiento

Canada

Canada
Centro	Ciudad	Estado o región	Estado
Royal Victoria Regional Health Centre	Barrie	Ontario	En reclutamiento
Arthur J E Child Comprehensive Cancer Centre	Calgary	Alberta	En reclutamiento
Cambridge Memorial Hospital	Cambridge	Ontario	En reclutamiento
CSSS Champlain-Charles Le Moyne	Greenfield Park	Quebec	En reclutamiento
Juravinski Cancer Centre at Hamilton Health Sciences	Hamilton	Ontario	En reclutamiento
Kingston Health Sciences Centre	Kingston	Ontario	En reclutamiento
Waterloo Regional Health Network	Kitchener	Ontario	En reclutamiento
London Regional Cancer Program	London	Ontario	En reclutamiento
Hotel-Dieu De Levis	Lévis	Quebec	En reclutamiento
Markham Stouffville Hospital	Markham	Ontario	En reclutamiento
Jewish General Hospital	Montreal	Quebec	En reclutamiento
Hopital Du Sacre-Coeur de Montreal	Montreal	Quebec	En reclutamiento
CIUSSSEMTL-Hopital Maisonneuve-Rosemont	Montreal	Quebec	En reclutamiento
Stronach Regional Health Centre at Southlake	Newmarket	Ontario	En reclutamiento
Lakeridge Health Oshawa	Oshawa	Ontario	En reclutamiento
Ottawa Hospital and Cancer Center-General Campus	Ottawa	Ontario	En reclutamiento
BCCA-Cancer Centre for the North	Prince George	British Columbia	En reclutamiento
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)	Québec	Quebec	En reclutamiento
Allan Blair Cancer Centre	Regina	Saskatchewan	En reclutamiento
Niagara Health System-Saint Catharines General	Saint Catharines	Ontario	En reclutamiento
Atlantic Health Sciences Corporation-Saint John Regional Hospital	Saint John	New Brunswick	En reclutamiento
Saskatoon Cancer Centre	Saskatoon	Saskatchewan	En reclutamiento
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont	Sherbrooke	Quebec	En reclutamiento
Doctor H. Bliss Murphy Cancer Centre	St. John's	Newfoundland and Labrador	En reclutamiento
Odette Cancer Centre- Sunnybrook Health Sciences Centre	Toronto	Ontario	En reclutamiento
Humber River Hospital	Toronto	Ontario	En reclutamiento
North York General Hospital	Toronto	Ontario	En reclutamiento
Saint Michael's Hospital	Toronto	Ontario	En reclutamiento
BCCA-Vancouver Cancer Centre	Vancouver	British Columbia	En reclutamiento
BCCA-Vancouver Island Cancer Centre	Victoria	British Columbia	En reclutamiento
Windsor Regional Cancer Centre	Windsor	Ontario	Suspendido

Puerto Rico

Puerto Rico
Centro	Ciudad	Estado o región	Estado
Pan American Center for Oncology Trials LLC - Cayey	Cayey		En reclutamiento
Pan American Center for Oncology Trials LLC - Dorado	Dorado		En reclutamiento
Doctors Cancer Center	Manati		En reclutamiento
Pan American Center for Oncology Trials LLC	San Juan		En reclutamiento
Pan American Center for Oncology Trials LLC - Mayaguez	San Juan	PR	En reclutamiento
Centro Comprensivo de Cancer de UPR	San Juan		En reclutamiento
PROncology	San Juan		En reclutamiento
San Juan City Hospital	San Juan		En reclutamiento
Pan American Center for Oncology Trials LLC - Ciudadela	San Juan		En reclutamiento

United States

United States
Centro	Ciudad	Estado o región	Estado
Abbeville General Hospital	Abbeville	Louisiana	En reclutamiento
UM Upper Chesapeake Hematology and Oncology - Aberdeen	Aberdeen	Maryland	En reclutamiento
Avera Cancer Institute-Aberdeen	Aberdeen	South Dakota	En reclutamiento
Cleveland Clinic Akron General	Akron	Ohio	En reclutamiento
Summa Health System - Akron Campus	Akron	Ohio	En reclutamiento
Phoebe Putney Memorial Hospital	Albany	Georgia	En reclutamiento
University of New Mexico Cancer Center	Albuquerque	New Mexico	En reclutamiento
Presbyterian Kaseman Hospital	Albuquerque	New Mexico	En reclutamiento
Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	En reclutamiento
Aultman Alliance Community Hospital	Alliance	Ohio	En reclutamiento

En el registro figuran 1027 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

2 de septiembre de 2026
Centro añadido
11 sites added (1077 total)
10661077
4 de agosto de 2026
Centro añadido
3 sites added (1066 total)
10631066

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05174169