Trial · NCT01516216
Study of Vitamin D in Untreated Metastatic Colorectal Cancer
NCT01516216, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2022-03-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Vitamin D in Untreated Metastatic Colorectal Cancer. Trials, record NCT01516216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01516216
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Vitamin D in Untreated Metastatic Colorectal Cancer
- NCT number
- NCT01516216
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 139 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- FOLFOX + bevacizumab, Vitamin D
- First posted
- 2012-01-24
- Last updated
- 2022-04-26
- Results first posted
- 2022-03-23
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression-free Survival (PFS) | Disease was evaluated every 4 cycles on treatment and off treatment every 8-16 weeks until PD or non-protocol therapy start if discontinued for reason other than PD. Participants were observed up to 28.5 months with maximum follow-up of 56.7 months. | Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Patients who discontinued treatment to pursue potentially curative resection were censored for progression-free survival at the time of surgery. Patients who had not experienced cancer progression or died were censored at their last known follow-up date. |
| Secondary | Median Overall Survival (OS) | Participants were followed for survival by clinic visit or telephone every 3 months post-treatment discontinuation up to 36 months from the date that the last participant was enrolled. Median follow-up was 22.9 months with maximum 56.7 months. | OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive. Patients who discontinued treatment to pursue potentially curative resection were censored for progression-free survival at the time of surgery. Patients who had not experienced cancer progression or died were censored at their last known follow-up date. |
| Secondary | Objective Response Rate | Disease was evaluated every 4 cycles on treatment. Median (maximum) treatment duration was 7.3 (28.5) months. | The objective response rate (ORR) was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Grade 3-5 Treatment-Related Neutropenia Toxicity Rate | AEs were evaluated at day 1 of each cycle on treatment and up to 30 days after the last dose. Maximum treatment duration is 28.5 months with median 7.3 months. | The percentage of treated participants experiencing grade 3-5 neutropenia with treatment attribution of possible, probable or definite based on Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms were counted. |
| Secondary | Number of Participants With Vitamin D Deficiency at Baseline | Baseline | Vitamin D deficiency was defined as plasma 25-hydroxyvitamin D \[25(OH)D\] level \<20 ng/mL as measured in one batch per established methods by an independent laboratory. |
| Secondary | Vitamin D Sufficiency Rate | Plasma samples were collected at 3 timepoints on treatment: first restaging (cycle 5, day 1), second restaging (cycle 9, day 1) and at treatment discontinuation. Median (maximum) treatment duration was 7.3 (28.5) months. | Percentage of participants that achieve Vitamin D sufficiency defined as plasma 25(OH)D \>=30 ng/mL on treatment as measured in one batch per established methods by an independent laboratory. |
| Secondary | Plasma 25-hydroxyvitamin D Levels | Plasma samples were collected at 4 timepoints on study: baseline, first restaging (cycle 5, day 1), second restaging (cycle 9, day 1) and at treatment discontinuation. Median (maximum) treatment duration was 7.3 (28.5) months. | Plasma 25-hydroxyvitamin D \[25(OH)D\] levels as measured in one batch per established methods by an independent laboratory. |
| Secondary | Hazard Ratio Between Baseline Plasma 25(OH)D Level and PFS | Baseline Plasma 25(OH)D Level and up to 28.5m for evaluation of PFS. | Plasma 25-hydroxyvitamin D \[25(OH)D\] levels as measured in one batch per established methods by an independent laboratory. Plasma 25(OH)D Level is used as continuous data. PFS is estimated based on Kaplan-Meier method (see outcome measure 1). The PFS hazard ratio associated with one unit increase of 25()H)D. |
| Secondary | Hazard Ratio Between Baseline Plasma 25(OH)D Levels and OS | Baseline Plasma 25(OH)D Level and up to maximum 56.7 months for evaluation of OS. | Plasma 25-hydroxyvitamin D \[25(OH)D\] levels as measured in one batch per established methods by an independent laboratory. Plasma 25(OH)D Level is used as continuous data. OS is estimated based on Kaplan-Meier method (see outcome measure 2). The OS hazard ratio associated with one unit increase of 25()H)D. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Progression-free Survival (PFS) | Disease was evaluated every 4 cycles on treatment and off treatment every 8-16 weeks until PD or non-protocol therapy start if discontinued for reason other than PD. Participants were observed up to 28.5 months with maximum follow-up of 56.7 months. | the analysis population is comprised of all randomized patients | Months | MEDIAN |
| SECONDARY | Median Overall Survival (OS) | Participants were followed for survival by clinic visit or telephone every 3 months post-treatment discontinuation up to 36 months from the date that the last participant was enrolled. Median follow-up was 22.9 months with maximum 56.7 months. | Months | MEDIAN | |
| SECONDARY | Objective Response Rate | Disease was evaluated every 4 cycles on treatment. Median (maximum) treatment duration was 7.3 (28.5) months. | The analysis population is comprised of the response evaluable subset. | percentage of participants | NUMBER |
| SECONDARY | Grade 3-5 Treatment-Related Neutropenia Toxicity Rate | AEs were evaluated at day 1 of each cycle on treatment and up to 30 days after the last dose. Maximum treatment duration is 28.5 months with median 7.3 months. | The analysis population is comprised of the subset evaluable for adverse events. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Vitamin D Deficiency at Baseline | Baseline | The analysis population is comprised of the subset with evaluable plasma samples at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Vitamin D Sufficiency Rate | Plasma samples were collected at 3 timepoints on treatment: first restaging (cycle 5, day 1), second restaging (cycle 9, day 1) and at treatment discontinuation. Median (maximum) treatment duration was 7.3 (28.5) months. | The analysis population is comprised of the subset with evaluable plasma samples at each collection timepoint. | percentage of participants | NUMBER |
| SECONDARY | Plasma 25-hydroxyvitamin D Levels | Plasma samples were collected at 4 timepoints on study: baseline, first restaging (cycle 5, day 1), second restaging (cycle 9, day 1) and at treatment discontinuation. Median (maximum) treatment duration was 7.3 (28.5) months. | The analysis population is comprised of the subset with evaluable plasma samples at each collection timepoint. | ng/mL | MEDIAN |
| SECONDARY | Hazard Ratio Between Baseline Plasma 25(OH)D Level and PFS | Baseline Plasma 25(OH)D Level and up to 28.5m for evaluation of PFS. | The analysis population is comprised of all participants with evaluable Plasma 25(OH)D Level samples at baseline. | hazard ratio | NUMBER |
| SECONDARY | Hazard Ratio Between Baseline Plasma 25(OH)D Levels and OS | Baseline Plasma 25(OH)D Level and up to maximum 56.7 months for evaluation of OS. | The analysis population is comprised of all participants with evaluable Plasma 25(OH)D Level samples at baseline. | hazard ratio | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Progression-free Survival (PFS) | Chemotherapy + Standard Dose Vitamin D | 11 | 95% Confidence Interval 9.5 to 14 | Months | |
| Median Progression-free Survival (PFS) | Chemotherapy + Higher Dose Vitamin D | 13 | 95% Confidence Interval 10.1 to 14.7 | Months | |
| Median Overall Survival (OS) | Chemotherapy + Standard Dose Vitamin D | 24.3 | 95% Confidence Interval 20.3 to 32.4 | Months | |
| Median Overall Survival (OS) | Chemotherapy + Higher Dose Vitamin D | 24.3 | 95% Confidence Interval 19.0 to 33.2 | Months | |
| Objective Response Rate | Chemotherapy + Standard Dose Vitamin D | 63 | 95% Confidence Interval 50 to 75 | percentage of participants | |
| Objective Response Rate | Chemotherapy + Higher Dose Vitamin D | 58 | 95% Confidence Interval 45 to 70 | percentage of participants | |
| Grade 3-5 Treatment-Related Neutropenia Toxicity Rate | Chemotherapy + Standard Dose Vitamin D | 31 | 95% Confidence Interval 21 to 44 | percentage of participants | |
| Grade 3-5 Treatment-Related Neutropenia Toxicity Rate | Chemotherapy + Higher Dose Vitamin D | 35 | 95% Confidence Interval 24 to 48 | percentage of participants | |
| Number of Participants With Vitamin D Deficiency at Baseline | Chemotherapy + Standard Dose Vitamin D | 39 | Participants | ||
| Number of Participants With Vitamin D Deficiency at Baseline | Chemotherapy + Higher Dose Vitamin D | 48 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy + Standard Dose Vitamin D | 70 | |
| Overall Study | STARTED | Chemotherapy + Higher Dose Vitamin D | 69 | |
| Overall Study | AE Evaluable | Chemotherapy + Standard Dose Vitamin D | 67 | |
| Overall Study | AE Evaluable | Chemotherapy + Higher Dose Vitamin D | 68 | |
| Overall Study | Response Evaluable | Chemotherapy + Standard Dose Vitamin D | 62 | |
| Overall Study | Response Evaluable | Chemotherapy + Higher Dose Vitamin D | 66 | |
| Overall Study | COMPLETED | Chemotherapy + Standard Dose Vitamin D | 0 | |
| Overall Study | COMPLETED | Chemotherapy + Higher Dose Vitamin D | 0 | |
| Overall Study | NOT COMPLETED | Chemotherapy + Standard Dose Vitamin D | 70 | |
| Overall Study | NOT COMPLETED | Chemotherapy + Higher Dose Vitamin D | 69 |
Source ClinicalTrials.gov
Adverse events638
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 | Ear pain | Ear and labyrinth disorders | Chemotherapy + Standard Dose Vitamin D | 0 | 67 | |
| other | Ear pain | Ear and labyrinth disorders | Chemotherapy + Higher Dose Vitamin D | 1 | 68 | |
| other | Ear and labyrinth disorders - Other | Ear and labyrinth disorders | Chemotherapy + Standard Dose Vitamin D | 0 | 67 | |
| other | Ear and labyrinth disorders - Other | Ear and labyrinth disorders | Chemotherapy + Higher Dose Vitamin D | 1 | 68 | |
| other | Anemia | Blood and lymphatic system disorders | Chemotherapy + Standard Dose Vitamin D | 36 | 67 | |
| other | Anemia | Blood and lymphatic system disorders | Chemotherapy + Higher Dose Vitamin D | 34 | 68 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Chemotherapy + Standard Dose Vitamin D | 2 | 67 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Chemotherapy + Higher Dose Vitamin D | 4 | 68 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Chemotherapy + Standard Dose Vitamin D | 6 | 67 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Chemotherapy + Higher Dose Vitamin D | 4 | 68 |
1 to 10 of 638Source ClinicalTrials.gov
See all 638 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy + Standard Dose Vitamin D | 54 | 67 |
| Total, all-cause mortality | Chemotherapy + Higher Dose Vitamin D | 45 | 68 |
| Total, other adverse events | Chemotherapy + Standard Dose Vitamin D | 65 | 67 |
| Total, other adverse events | Chemotherapy + Higher Dose Vitamin D | 67 | 68 |
| Total, serious adverse events | Chemotherapy + Standard Dose Vitamin D | 39 | 67 |
| Total, serious adverse events | Chemotherapy + Higher Dose Vitamin D | 47 | 68 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30964527 | BACKGROUND |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chemotherapy + Standard Dose Vitamin D vs Chemotherapy + Higher Dose Vitamin D: deaths from any cause | Trial comparisons |
| Chemotherapy + Standard Dose Vitamin D vs Chemotherapy + Higher Dose Vitamin D: Number of Participants With Vitamin D Deficiency at Baseline | Trial comparisons |
| Chemotherapy + Standard Dose Vitamin D vs Chemotherapy + Higher Dose Vitamin D: 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/NCT01516216
GET https://conductscience.org/api/trials/v1/NCT01516216/results?page=2