scholarly journals Impact of the COVID-19 outbreak on adjuvant chemotherapy for patients with stage II or III colon cancer: experiences from a multicentre clinical trial in China

2020 ◽  
Vol 27 (3) ◽  
Author(s):  
L. Sun ◽  
Y. Xu ◽  
T. Zhang ◽  
Y. Yang
Keyword(s):  
Clinical Trial ◽  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Stage Ii ◽  
Multicentre Clinical Trial

Phase II/III study of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer:NRG-GI005 (COBRA).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. TPS148-TPS148
Author(s):  
Van K. Morris ◽  
Greg Yothers ◽  
Scott Kopetz ◽  
Samuel A. Jacobs ◽  
Peter C. Lucas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Colon Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Predictive Biomarkers ◽  
Circulating Tumor Dna ◽  
Stage Ii ◽  
Phase Iii ◽  
Tumor Dna

TPS148 Background: There are currently no validated predictive biomarkers for stage II resected colon cancer (CC) after adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) that is shed into the bloodstream represents a highly specific and sensitive approach for identifying microscopic or residual tumor cells. For patients (pts) with CC, the detection of ctDNA is associated with persistent disease after resection and may outperform traditional clinical and pathological features as a prognostic factor to assess risk for recurrence. We hypothesize that for pts whose stage II colon cancer has been resected and who have no traditional high-risk features, a positive ctDNA status may identify those who will benefit from adjuvant chemotherapy. Methods: In this prospective phase II/III clinical trial, pts (N=1,408) with resected stage II CC without traditional high-risk features and whom the evaluating oncologist deems suitable for no adjuvant chemotherapy will be randomized 1:1 into 2 arms:standard-of-care/observation (Arm A), or prospective testing for ctDNA (Arm B). Postoperative blood will be analyzed for ctDNA with the GuardantHealth LUNAR panel, covering CC-relevant mutations and CC-specific methylation profiling. Pts in Arm B with ctDNA detected will be treated with 6 months of adjuvant (FOLFOX) chemotherapy. For all pts in Arm A, ctDNA status will be analyzed retrospectively at the time of endpoint analysis. The primary endpoints are clearance of ctDNA with adjuvant chemotherapy (phase II) and recurrence-free survival (RFS) for “ctDNA-detected” pts treated with or without adjuvant chemotherapy (phase III). Secondary endpoints will include time-to-event outcomes (OS, RFS, TTR) by ctDNA marker status and treatment, prevalence of detectable ctDNA in stage II CC, and rates of compliance with assigned intervention. Archived normal and matched tumor and blood samples will be collected for exploratory correlative research. The trial is actively accruing towards the phase II endpoint across all US and Canadian cooperative groups. Support:U10-CA-180868, -180822; UG1CA-189867; GuardantHealth. Clinical trial information: NCT04068103.

NRG-GI005 (COBRA): Phase II/III study of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. TPS261-TPS261
Author(s):  
Van K. Morris ◽  
Greg Yothers ◽  
Scott Kopetz ◽  
Samuel A. Jacobs ◽  
Peter C. Lucas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Colon Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Circulating Tumor Dna ◽  
Stage Ii ◽  
Phase Iii ◽  
Stage Ii Colon Cancer ◽  
Tumor Dna

TPS261 Background: There are currently no validated predictive biomarkers for stage II resected colon cancer (CC) after adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) that is shed into the bloodstream represents a highly specific and sensitive approach for identifying microscopic or residual tumor cells. For patients (pts) with CC, the detection of ctDNA is associated with persistent disease after resection and may outperform traditional clinical and pathological features as a prognostic factor to assess risk for recurrence. We hypothesize that for pts whose stage II colon cancer has been resected and who have no traditional high-risk features, a positive ctDNA status may identify those who will benefit from adjuvant chemotherapy. Methods: In this prospective phase II/III clinical trial, pts (N=1,408) with resected stage II CC without traditional high-risk features and whom the evaluating oncologist deems suitable for no adjuvant chemotherapy will be randomized 1:1 into 2 arms: standard-of-care/observation (Arm A), or prospective testing for ctDNA (Arm B). Postoperative blood will be analyzed for ctDNA with the GuardantHealth LUNAR panel, covering CC-relevant mutations and CC-specific methylation profiling. Pts in Arm B with ctDNA detected will be treated with 6 months of adjuvant (FOLFOX) chemotherapy. For all pts in Arm A, ctDNA status will be analyzed retrospectively at the time of endpoint analysis. The primary endpoints are clearance of ctDNA with adjuvant chemotherapy (phase II) and recurrence-free survival (RFS) for “ctDNA-detected” pts treated with or without adjuvant chemotherapy (phase III). Secondary endpoints will include time-to-event outcomes (OS, RFS, TTR) by ctDNA marker status and treatment, prevalence of detectable ctDNA in stage II CC, and rates of compliance with assigned intervention. Archived normal and matched tumor and blood samples will be collected for exploratory correlative research. Trial accrual is anticipated across all US and Canadian cooperative groups.NCT#: 04068103. Support: U10-CA-180868, -180822; UG1CA-189867; GuardantHealth. Clinical trial information: 04068103.

Phase II/III study of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS4121-TPS4121
Author(s):  
Van K. Morris ◽  
Greg Yothers ◽  
Scott Kopetz ◽  
Samuel A. Jacobs ◽  
Peter C. Lucas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Colon Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Circulating Tumor Dna ◽  
Stage Ii ◽  
Phase Iii ◽  
Stage Ii Colon Cancer ◽  
Tumor Dna

TPS4121 Background: There are currently no validated predictive biomarkers for stage II resected colon cancer (CC) after adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) that is shed into the bloodstream represents a highly specific and sensitive approach for identifying microscopic or residual tumor cells. For patients (pts) with CC, the detection of ctDNA is associated with persistent disease after resection and may outperform traditional clinical and pathological features as a prognostic factor to assess risk for recurrence. We hypothesize that for pts whose stage II colon cancer has been resected and who have no traditional high-risk features, a positive ctDNA status may identify those who will benefit from adjuvant chemotherapy. Methods: In this prospective phase II/III clinical trial, pts (N=1,408) with resected stage II CC without traditional high-risk features and whom the evaluating oncologist deems suitable for no adjuvant chemotherapy will be randomized 1:1 into 2 arms: standard-of-care/observation (Arm A), or prospective testing for ctDNA (Arm B). Postoperative blood will be analyzed for ctDNA with the GuardantHealth LUNAR panel, covering CC-relevant mutations and CC-specific methylation profiling. Pts in Arm B with ctDNA detected will be treated with 6 months of adjuvant (FOLFOX) chemotherapy. For all pts in Arm A, ctDNA status will be analyzed retrospectively at the time of endpoint analysis. The primary endpoints are clearance of ctDNA with adjuvant chemotherapy (phase II) and recurrence-free survival (RFS) for “ctDNA-detected” pts treated with or without adjuvant chemotherapy (phase III). Secondary endpoints will include time-to-event outcomes (OS, RFS, TTR) by ctDNA marker status and treatment, prevalence of detectable ctDNA in stage II CC, and rates of compliance with assigned intervention. Archived normal and matched tumor and blood samples will be collected for exploratory correlative research. The trial is actively accruing towards the phase II endpoint across all US and Canadian cooperative groups. Support: U10-CA-180868, -180822; UG1CA-189867; GuardantHealth. Clinical trial information: NCT04068103 .

Phase II/III study of Circulating tumOr DNA as a predictive BiomaRker in Adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS3622-TPS3622
Author(s):  
Van K. Morris ◽  
Greg Yothers ◽  
Scott Kopetz ◽  
Samuel A. Jacobs ◽  
Peter C. Lucas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Colon Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Circulating Tumor Dna ◽  
Stage Ii ◽  
Phase Iii ◽  
Stage Ii Colon Cancer ◽  
Tumor Dna

TPS3622 Background: There are currently no validated predictive biomarkers for stage II resected colon cancer (CC) after adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) that is shed into the bloodstream represents a highly specific and sensitive approach for identifying microscopic or residual tumor cells. For patients (pts) with CC, the detection of ctDNA is associated with persistent disease after resection and may outperform traditional clinical and pathological features as a prognostic factor to assess risk for recurrence. We hypothesize that for pts whose stage II colon cancer has been resected and who have no traditional high-risk features, a positive ctDNA status may identify those who will benefit from adjuvant chemotherapy. Methods: In this prospective phase II/III clinical trial, pts (N = 1,408) with resected stage II CC without traditional high-risk features and whom the evaluating oncologist deems suitable for no adjuvant chemotherapy will be randomized 1:1 into 2 arms: standard-of-care/observation (Arm A), or prospective testing for ctDNA (Arm B). Postoperative blood will be analyzed for ctDNA with the GuardantHealth LUNAR panel, covering CC-relevant mutations and CC-specific methylation profiling. Pts in Arm B with ctDNA detected will be treated with 6 months of adjuvant (FOLFOX) chemotherapy. For all pts in Arm A, ctDNA status will be analyzed retrospectively at the time of endpoint analysis. The primary endpoints are clearance of ctDNA with adjuvant chemotherapy (phase II) and recurrence-free survival (RFS) for “ctDNA-detected” pts treated with or without adjuvant chemotherapy (phase III). Secondary endpoints will include time-to-event outcomes (OS, RFS, TTR) by ctDNA marker status and treatment, prevalence of detectable ctDNA in stage II CC, and rates of compliance with assigned intervention. Archived normal and matched tumor and blood samples will be collected for exploratory correlative research. The trial is actively accruing towards the phase II endpoint in North America. NCT#: 04068103. Support: U10-CA-180868, -180822; UG1CA-189867; GuardantHealth. Clinical trial information: NCT04068103.

Age Determines Adjuvant Chemotherapy Use in Resected Stage II Colon Cancer

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Brendan L. Hagerty ◽  
John G. Aversa ◽  
Dana A. Dominguez ◽  
Jeremy L. Davis ◽  
Jonathan M. Hernandez ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Stage Ii ◽  
Resected Stage ◽  
Stage Ii Colon Cancer

Microsatellite Status and Adjuvant Chemotherapy in Patients with Stage II Colon Cancer

2010 ◽  
Vol 6 (3) ◽  
pp. 148-157 ◽  
Author(s):  
Jean-Baptiste Bachet ◽  
Pierre Laurent-Puig ◽  
Aimery de Gramont ◽  
Thierry André
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Stage Ii ◽  
Stage Ii Colon Cancer

scholarly journals Analysis of the benefit of the adjuvant chemotherapy in stage II colon cancer according to the presence of classic poor risk factors: Our experience in Ramon y Cajal Hospital

2018 ◽  
Vol 29 ◽  
pp. v64
Author(s):  
C. Saavedra Serrano ◽  
M. Villamayor Delgado ◽  
E. Corral de la Fuente ◽  
A. Barquín García ◽  
J. Serrano Domingo ◽  
...  
Keyword(s):  
Risk Factors ◽  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Stage Ii ◽  
Poor Risk ◽  
Stage Ii Colon Cancer ◽  
Ramón Y Cajal

Eligibility of Real-World Patients With Stage II and III Colon Cancer for Adjuvant Chemotherapy Trials

2020 ◽  
Vol 19 (4) ◽  
pp. e226-e234 ◽  
Author(s):  
Atul Batra ◽  
Shiying Kong ◽  
Winson Y. Cheung
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Real World ◽  
Stage Ii
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