Trial · NCT01824875
Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors
NCT01824875, Phase 2, Completed, ECOG-ACRIN Cancer Research Group; results first posted 2022-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors. Trials, record NCT01824875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01824875
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors
- NCT number
- NCT01824875
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 144 participants, actual
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Conditions
- Gastrinoma, Glucagonoma, Insulinoma, Islet Cell Carcinoma, Pancreatic Polypeptide Tumor, Recurrent Islet Cell Carcinoma, Somatostatinoma
- Interventions
- temozolomide, capecitabine
- First posted
- 2013-04-05
- Last updated
- 2026-09-29
- Results first posted
- 2022-10-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | Assessed every 3 months for 3 years and then every 6 months for years 3-5 | Progression-free survival (PFS) is defined as the time from randomization to progression or death without evidence of progression. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier method was used to estimate PFS. |
| Secondary | Proportion of Patients With Response | Assessed every 3 months for 3 years and then every 6 months for years 3-5 | Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Overall Survival | Assessed every 3 months for 3 years and then every 6 months for years 3-5 | Overall survival is defined as time from randomization to death or date last known alive. |
| Secondary | Association Between Methyl Guanine Methyltransferase (MGMT) Status by Immunohistochemistry (IHC) and Response | Assessed every 3 months for 3 years and then every 6 months for years 3-5 | Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. MGMT status was determined by IHC using paraffin-embedded sections of 4µm. A score (H-score) was generated based on the findings and scoring was performed by two pathologists. This H-score ranges from 0 (no staining in the tumor) to 300 (diffuse intense staining of the tumor). The highest score was used if there was disagreement. H-scores were grouped into 3 standard categories for MGMT status: Category 1 - \<=50 Category 2 - 51-100 Category 3 - \>100 |
| Secondary | Association Between Methyl Guanine Methyltransferase (MGMT) Status by Promoter Methylation and Response | Assessed every 3 months for 3 years and then every 6 months for years 3-5 | Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. MGMT status is determined by promoter methylation, a clinically validated methylation-specific polymerase chain reaction (PCR) analysis. A tumor sample is considered positive for MGMT promoter methylation if an 80bp band is detected in the methylated PCR reaction. It would be considered MGMT negative if an 80bp band is not detected in the methylated PCR reaction. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | Assessed every 3 months for 3 years and then every 6 months for years 3-5 | Only eligible patients were included in this analysis. | months | MEDIAN |
| SECONDARY | Proportion of Patients With Response | Assessed every 3 months for 3 years and then every 6 months for years 3-5 | Only eligible patients were included in this analysis. | proportion of participants | NUMBER |
| SECONDARY | Overall Survival | Assessed every 3 months for 3 years and then every 6 months for years 3-5 | Only eligible patients were included in this analysis. | months | MEDIAN |
| SECONDARY | Association Between Methyl Guanine Methyltransferase (MGMT) Status by Immunohistochemistry (IHC) and Response | Assessed every 3 months for 3 years and then every 6 months for years 3-5 | Only eligible patients with MGMT status by IHC data available were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Association Between Methyl Guanine Methyltransferase (MGMT) Status by Promoter Methylation and Response | Assessed every 3 months for 3 years and then every 6 months for years 3-5 | Only eligible patients with MGMT by promoter methylation data available were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Arm A (Temozolomide) | 15.1 | 95% Confidence Interval 10.5 to 21.0 | months | |
| Progression-free Survival | Arm B (Temozolomide and Capecitabine) | 23.2 | 95% Confidence Interval 16.6 to 32.2 | months | |
| Proportion of Patients With Response | Arm A (Temozolomide) | 0.338 | 90% Confidence Interval 0.241 to 0.447 | proportion of participants | |
| Proportion of Patients With Response | Arm B (Temozolomide and Capecitabine) | 0.397 | 90% Confidence Interval 0.297 to 0.504 | proportion of participants | |
| Overall Survival | Arm A (Temozolomide) | 53.8 | 95% Confidence Interval 35.7 to NA | months | |
| Overall Survival | Arm B (Temozolomide and Capecitabine) | 58.7 | 95% Confidence Interval 44.7 to NA | months | |
| Association Between Methyl Guanine Methyltransferase (MGMT) Status by Immunohistochemistry (IHC) and Response | MGMT by IHC: 1-2 | No response | 30 | Participants | |
| Association Between Methyl Guanine Methyltransferase (MGMT) Status by Immunohistochemistry (IHC) and Response | MGMT by IHC: 3 | No response | 29 | Participants | |
| Association Between Methyl Guanine Methyltransferase (MGMT) Status by Immunohistochemistry (IHC) and Response | MGMT by IHC: 1-2 | Response | 33 | Participants | |
| Association Between Methyl Guanine Methyltransferase (MGMT) Status by Immunohistochemistry (IHC) and Response | MGMT by IHC: 3 | Response | 5 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Temozolomide) | 72 | |
| Overall Study | STARTED | Arm B (Temozolomide and Capecitabine) | 72 | |
| Overall Study | Received Treatment and Adverse Event Data Available | Arm A (Temozolomide) | 68 | |
| Overall Study | Received Treatment and Adverse Event Data Available | Arm B (Temozolomide and Capecitabine) | 71 | |
| Overall Study | Eligible | Arm A (Temozolomide) | 65 | |
| Overall Study | Eligible | Arm B (Temozolomide and Capecitabine) | 68 | |
| Overall Study | Eligible Patients With MGMT by IHC Data Available | Arm A (Temozolomide) | 47 | |
| Overall Study | Eligible Patients With MGMT by IHC Data Available | Arm B (Temozolomide and Capecitabine) | 50 | |
| Overall Study | Eligible Patients With MGMT by Promoter Methylation Data Available | Arm A (Temozolomide) | 27 | |
| Overall Study | Eligible Patients With MGMT by Promoter Methylation Data Available | Arm B (Temozolomide and Capecitabine) | 30 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events92
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm A (Temozolomide) | 21 | 68 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Temozolomide and Capecitabine) | 27 | 71 | |
| other | Fatigue | General disorders | Arm A (Temozolomide) | 44 | 68 | |
| other | Fatigue | General disorders | Arm B (Temozolomide and Capecitabine) | 45 | 71 | |
| other | Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | Arm A (Temozolomide) | 3 | 68 | |
| other | Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | Arm B (Temozolomide and Capecitabine) | 23 | 71 | |
| other | Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Arm A (Temozolomide) | 1 | 68 | |
| other | Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Arm B (Temozolomide and Capecitabine) | 12 | 71 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A (Temozolomide) | 12 | 68 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm B (Temozolomide and Capecitabine) | 13 | 71 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Temozolomide) | 42 | 72 |
| Total, all-cause mortality | Arm B (Temozolomide and Capecitabine) | 33 | 72 |
| Total, other adverse events | Arm A (Temozolomide) | 63 | 68 |
| Total, other adverse events | Arm B (Temozolomide and Capecitabine) | 70 | 71 |
| Total, serious adverse events | Arm A (Temozolomide) | 15 | 68 |
| Total, serious adverse events | Arm B (Temozolomide and Capecitabine) | 32 | 71 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36260828 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Temozolomide) vs Arm B (Temozolomide and Capecitabine): deaths from any cause | Trial comparisons |
| Arm A (Temozolomide) vs Arm B (Temozolomide and Capecitabine): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01824875
GET https://conductscience.org/api/trials/v1/NCT01824875/events?page=2