Gastrointestinal Neoplasm - Colorectal Cancer

NCT01515787

Clinical Trial Information


Trial Number: NCT01515787 (ClinicalTrials.gov)
Disease Type:
  • Gastrointestinal Neoplasm - Colorectal Cancer
Trial Title:
A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision (PROSPECT)
Study ID:
N1048
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT01515787-D2 Dataset NCT01515787-D2-Dataset.csv (ae) is one of 2 datasets associated with PubMed ID 37272534. This dataset contains toxicity data presented in the primary manuscript results section and Supplementary Tables 2A and 2B.
NCT01515787-D1 Dataset NCT01515787-D1-Dataset.csv (final) is one of 2 datasets associated with PubMed ID 37272534. This dataset contains demographic and outcomes data presented in the primary manuscript and Supplementary Tables 3A, 3B, and 4 and the Supplementary Figure.

NCT02921256

Clinical Trial Information


Trial Number: NCT02921256 (ClinicalTrials.gov)
Disease Type:
  • Gastrointestinal Neoplasm - Colorectal Cancer
Trial Title:
Use of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Study ID:
NRG-GI002
Images are available?:
No
Is this a NCI-MATCH Trial?:
No

NCT01150045

Clinical Trial Information


Trial Number: NCT01150045 (ClinicalTrials.gov)
Disease Type:
  • Gastrointestinal Neoplasm - Colorectal Cancer
Trial Title:
A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer
Study ID:
CALGB-80702
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT01150045-D4 Dataset NCT01150045-D4-Dataset.csv (Table2) is one of 4 datasets associated with PubMed ID 33821899. This dataset contains the data presented in the adverse events table (Table 2). The data is one row- per-patient for each treatment phase. The first treatment phase is while FOLFOX is given with Celecoxib or Placebo. The second treatment phase is after completing/ending FOLFOX therapy and continuing with Celecoxib or Placebo. The maximum grade variables are all possibly, probably or definitely related to treatment.
NCT01150045-D3 Dataset NCT01150045-D3-Dataset.csv (Table1) is one of 4 datasets associated with PubMed ID 33821899. This dataset contains the data presented in the baseline characteristics table (Table 1), the Kaplan-Meier figures (Figure 3a/b), the Patient Outcome analysis, determine the patients that experienced at least one grade 1 or greater adverse event possibly related to treatment, and the Treatment Adherence analysis.
NCT01150045-D2 Dataset NCT01150045-D2-Dataset.csv (Figure2) is one of 4 datasets associated with PubMed ID 33821899. This dataset contains the data presented in Figure 2 of the analysis. The dataset contains one row for each patient. There is a variable for off-treatment reason for grouping patients into different segments/colors of the bar chart in the figure, and a time variable for binning patients into the bar chart on the x-axis.
NCT01150045-D1 Dataset NCT01150045-D1-Dataset.csv (Figure1) is one of 4 datasets associated with PubMed ID 33821899. This dataset contains the data presented in the CONSORT diagram (Figure 1) from the manuscript. The dataset has one row-per-patient.

NCT00303628

Clinical Trial Information


Trial Number: NCT00303628 (ClinicalTrials.gov)
Disease Type:
  • Gastrointestinal Neoplasm - Colorectal Cancer
Trial Title:
Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation
Study ID:
E5204
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT00303628-D5 There are five different submissions for PMID 31852811 from trial E5204. This dataset, NCT00303628-D5, contains PRO FACT/GOG-Ntx Data. Dataset NCT00303628-D1 contains baseline, treatment, and efficacy data. Dataset NCT00303628-D2 contains toxicity data. Dataset NCT00303628-D3 contains PRO Bowel function/uniscale data. Dataset NCT00303628-D4 contains PRO FACT-Diarrhea Data.
NCT00303628-D4 There are five different submissions for PMID 31852811 from trial E5204. This dataset, NCT00303628-D4, contains PRO FACT-Diarrhea Data. Dataset NCT00303628-D1 contains baseline, treatment, and efficacy data. Dataset NCT00303628-D2 contains toxicity data. Dataset NCT00303628-D3 contains PRO Bowel function/uniscale data. Dataset NCT00303628-D5 contains PRO FACT/GOG-Ntx Data.
NCT00303628-D3 There are five different submissions for PMID 31852811 from trial E5204. This dataset, NCT00303628-D3, contains PRO Bowel function/uniscale data. Dataset NCT00303628-D1 contains baseline, treatment, and efficacy data. Dataset NCT00303628-D2 contains toxicity data. Dataset NCT00303628-D4 contains PRO FACT-Diarrhea Data. Dataset NCT00303628-D5 contains PRO FACT/GOG-Ntx Data.
NCT00303628-D2 There are five different submissions for PMID 31852811 from trial E5204. This dataset, NCT00303628-D2, contains toxicity data. Dataset NCT00303628-D1 contains baseline, treatment, and efficacy data. Dataset NCT00303628-D3 contains PRO Bowel function/uniscale data. Dataset NCT00303628-D4 contains PRO FACT-Diarrhea Data. Dataset NCT00303628-D5 contains PRO FACT/GOG-Ntx Data.
NCT00303628-D1 There are five different submissions for PMID 31852811 from trial E5204. This dataset, NCT00303628-D1, contains baseline, treatment, and efficacy data. Dataset NCT00303628-D2 contains toxicity data. Dataset NCT00303628-D3 contains PRO Bowel function/uniscale data. Dataset NCT00303628-D4 contains PRO FACT-Diarrhea Data. Dataset NCT00303628-D5 contains PRO FACT/GOG-Ntx Data.

NCT00003835

Clinical Trial Information


Trial Number: NCT00003835 (ClinicalTrials.gov)
Disease Type:
  • Gastrointestinal Neoplasm - Colorectal Cancer
Trial Title:
Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC# 616348) Plus Fluorouracil/Leucovorin (5-FU/LV) Versus Fluorouracil/Leucovorin Alone After Curative Resection for Patients With Stage III Colon Cancer
Study ID:
C89803
Images are available?:
No
Is this a NCI-MATCH Trial?:
No

NCT00265850

Clinical Trial Information


Trial Number: NCT00265850 (ClinicalTrials.gov)
Disease Type:
  • Gastrointestinal Neoplasm - Colorectal Cancer
Trial Title:
A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU/ Leucovorin With Bevacizumab, or Cetuximab (C225), or With the Combination of Bevacizumab and Cetuximab for Patients With Untreated Metastatic Adenocarcinoma of the Colon or Rectum
Study ID:
C80405
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT00265850-D15 Dataset NCT00265850-D15-Dataset.csv (nctn_cms) is one of 2 datasets associated with PubMed ID 31042420, a non-primary publication for trial C80405. This dataset contains the data to determine the predictive and prognostic value of the consensus molecular subtypes (CMSs) of colorectal cancer (CRC).

Data from this trial’s primary publication can be found in NCT00265850-D1 through -D8.
NCT00265850-D14 Dataset NCT00265850-D14-Dataset.csv (consort) is one of 2 datasets associated with PubMed ID 31042420, a non-primary publication from trial C80405. This dataset contains the data presented in the consort diagram for the secondary endpoint of determining the predictive and prognostic value of the consensus molecular subtypes (CMSs) of colorectal cancer.

Data from this trial’s primary publication can be found in NCT00265850-D1 through -D8. Data that are identical to those presented in NCT00265850-D1 through -D8 are not duplicated in this submission.
NCT00265850-D13 Dataset NCT00265850-D13-Dataset.csv (nctn_pcr) is one of 5 datasets associated with PubMed ID 30865548. This dataset contains data on the clinical characteristics, demographics, and endpoint analyses. For the 12 biomarker point mutation variables, missing values indicate that PCR testing was not performed for this patient. Otherwise, for clinical variables, missing values indicate that the data was not collected for this patient.

This data submission, NCT00265850-D13-Dataset.csv, contains the data used to generate the results in PubMed ID 30865548, a non-primary publication from trial C80405. Data from this trial’s primary publication can be found in datasets NCT00265850-D1-Dataset.csv through NCT00265850-D8-Dataset.csv. Data that are identical to those presented in these available datasets are not duplicated in this submission.
NCT00265850-D12 Dataset NCT00265850-D12-Dataset.csv (consort_ras) is one of 5 datasets associated with PubMed ID 30865548. This dataset allows you to identify which of the 1329 patients generated biomarker data. Of the 1329 patients, this dataset will allow you to identify which underwent PCR testing (n=843), and those which were included in the RAS analysis population.

This data submission, NCT00265850-D12-Dataset.csv, contains the data used to generate the results in PubMed ID 30865548, a non-primary publication from trial C80405. Data from this trial’s primary publication can be found in datasets NCT00265850-D1-Dataset.csv through NCT00265850-D8-Dataset.csv. Data that are identical to those presented in these available datasets are not duplicated in this submission.
NCT00265850-D11 Dataset NCT00265850-D11-Dataset.csv (consort_mut_load) is one of 5 datasets associated with PubMed ID 30865548. This dataset allows you to identify which of the 1329 patients generated biomarker data. Of the 1329 patients, this dataset will also allow you to identify which patients underwent Foundation Medicine Testing (n=559), of those which had mutation load result (n=536), and those that were included in the Mutation load analysis population (n=473).

This data submission, NCT00265850-D11-Dataset.csv, contains the data used to generate the results in PubMed ID 30865548, a non-primary publication from trial C80405. Data from this trial’s primary publication can be found in datasets NCT00265850-D1-Dataset.csv through NCT00265850-D8-Dataset.csv. Data that are identical to those presented in these available datasets are not duplicated in this submission.
NCT00265850-D10 NCT00265850-D10 (consort_msi) is one of 5 datasets associated with PubMed ID 30865548, a non-primary publication from trial C80405. This dataset allows you to identify which of the 1329 patients generated biomarker data. Of the 1329 patients, this dataset will allow you to identify which underwent MSI testing (n=797), which underwent Foundation Medicine Testing (n=559), which patients had either MSI OR Foundation Medicine testing (n=829), and which were ultimately included in the MSI analysis population (n=827). The wording in the consort diagram “Both MSI and Foundation Medicine Testing (n=829)” does not accurately describe the 829 patient subgroup. The 829 patients represent the patients with “Either MSI or Foundation Medicine Testing.”

Data from this trial’s primary publication can be found in datasets NCT00265850-D1 through -D8. Data that are identical to those presented in these available datasets are not duplicated in this submission.
NCT00265850-D9 Dataset NCT00265850-D9-Dataset.csv (consort_braf) is one of 5 datasets associated with PubMed ID 30865548. This dataset contains information to identify which (n=843) patients were included in the BRAF analysis population.

This data submission, NCT00265850-D9-Dataset.csv, contains the data used to generate the results in PubMed ID 30865548, a non-primary publication from trial C80405. Data from this trial’s primary publication can be found in datasets NCT00265850-D1-Dataset.csv through NCT00265850-D8-Dataset.csv. Data that are identical to those presented in these available datasets are not duplicated in this submission.
NCT00265850-D8 Dataset NCT00265850-D8-Dataset.csv (supplemental_modreasons) is one of 8 datasets associated with PubMed ID 28632865. This dataset contains information that will allow you to reproduce the frequency of treatment modifications from the supplemental Treatment Administration table.
NCT00265850-D7 Dataset NCT00265850-D7-Dataset.csv (grade5) is one of 8 datasets associated with PubMed ID 28632865. This dataset contains information that will allow you to reproduce the number of deaths on treatment from the manuscript.
NCT00265850-D6 Dataset NCT00265850-D6-Dataset.csv (table2) is one of 8 datasets associated with PubMed ID 28632865. This dataset contains information that will allow you to reproduce table 2 of the manuscript.

NCT00058474

Clinical Trial Information


Trial Number: NCT00058474 (ClinicalTrials.gov)
Disease Type:
  • Gastrointestinal Neoplasm - Colorectal Cancer
Trial Title:
A Clinical Trial Comparing Preoperative Radiation Therapy And Capecitabine With or Without Oxaliplatin With Preoperative Radiation Therapy And Continuous Intravenous Infusion Of 5-Fluorouracil With or Without Oxaliplatin In The Treatment Of Patients With Operable Carcinoma Of The Rectum
Study ID:
NSABP-R-04
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT00058474-D1 The file NCT00058474-D1-Dataset.csv contains all data necessary to produce the results reported in the above manuscript.

NCT01099449

Clinical Trial Information


Trial Number: NCT01099449 (ClinicalTrials.gov)
Disease Type:
  • Gastrointestinal Neoplasm - Colorectal Cancer
Trial Title:
A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity
Study ID:
NCCTG-N08CB
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT01099449-D7 Dataset NCT01099449-D7-Dataset.csv (table2) is one of 7 datasets associated with PubMed ID 24297951. This dataset contains the information in table 2: FOLFOX dose reduction and discontinuation by treatment arm.
NCT01099449-D6 Dataset NCT01099449-D6-Dataset.csv (figure6) is one of 7 datasets associated with PubMed ID 24297951. This dataset contains the information in figure 6: Oxaliplatin use.
NCT01099449-D5 Dataset NCT01099449-D5-Dataset.csv (gr2neurotox_fig45) is one of 7 datasets associated with PubMed ID 24297951. This dataset contains the information for the incidence rates of CTCAE grade 2 or worse neurotoxicity from the “Chronic Peripheral Neurotoxicity” sub-section of the “Results” section, as well as figures 4 and 5. Note that the data provided in this submission are the correct data and will not match the publication exactly.
NCT01099449-D4 Dataset NCT01099449-D4-Dataset.csv (figure3) is one of 7 datasets associated with PubMed ID 24297951. This dataset contains the information in figure 3: Peripheral sensory neuropathy.
NCT01099449-D3 Dataset NCT01099449-D3-Dataset.csv (figure2) is one of 7 datasets associated with PubMed ID 24297951. This dataset contains the information in figure 2: Acute symptoms.
NCT01099449-D2 Dataset NCT01099449-D2-Dataset.csv (figure1) is one of 7 datasets associated with PubMed ID 24297951. This dataset contains the information in figure 1: CONSORT diagram.
NCT01099449-D1 Dataset NCT01099449-D1-Dataset.csv (table1) is one of 7 datasets associated with PubMed ID 24297951. This dataset contains the information in table 1: Baseline Patient Characteristics.

NCT00002968

Clinical Trial Information


Trial Number: NCT00002968 (ClinicalTrials.gov)
Disease Type:
  • Gastrointestinal Neoplasm - Colorectal Cancer
Trial Title:
Phase III Randomized Study of Adjuvant Immunotherapy With Monoclonal Antibody 17-1A Versus No Adjuvant Therapy Following Resection for State II (Modified Astler-Coller B2) Adenocarcinoma of the Colon
Study ID:
C9581
Images are available?:
No
Is this a NCI-MATCH Trial?:
No

NCT00003594

Clinical Trial Information


Trial Number: NCT00003594 (ClinicalTrials.gov)
Disease Type:
  • Gastrointestinal Neoplasm - Colorectal Cancer
Trial Title:
A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum
Study ID:
N9741
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT00003594-D4 The NCT00003594_D4end_at dataset is one of 4 datasets associated with PubMed ID 14665611. This dataset contains information per patient regarding end of treatment timing and reason. Note: These datasets have been updated since the primary publication and may not match the exact results reported in the primary manuscript.
NCT00003594-D3 The NCT00003594_D3cytox dataset is one of 4 datasets associated with PubMed ID 14665611. This dataset contains information per patient, per cycle, per adverse event during treatment. Note: These datasets have been updated since the primary publication and may not match the exact results reported in the primary manuscript.
NCT00003594-D2 The NCT00003594_D2cycle dataset is one of 4 datasets associated with PubMed ID 14665611. This dataset contains information per patient, per cycle regarding dosing and overall response assessment status. Note: These datasets have been updated since the primary publication and may not match the exact results reported in the primary manuscript.
NCT00003594-D1 The NCT00003594_D1crse dataset is one of 4 datasets associated with PubMed ID 14665611. This dataset contains information regarding patient-level information including eligibility, baseline characteristics, and best response. It also includes information to analyze overall survival and time to progression.