Trial · NCT00625183
Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma
NCT00625183, Phase 2, Terminated, Roswell Park Cancer Institute; results first posted 2014-09-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma. Trials, record NCT00625183. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00625183
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma
- NCT number
- NCT00625183
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
- Colorectal Cancer
- Interventions
- selenomethionine, capecitabine, oxaliplatin, laboratory biomarker analysis, pharmacological study, adjuvant therapy, neoadjuvant therapy, therapeutic conventional surgery, radiation therapy
- First posted
- 2008-02-28
- Last updated
- 2017-11-17
- Results first posted
- 2014-09-26
- Limitations and caveats
- Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Pathological Response Rate | After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically. | |
| Primary | Rate of T-downstaging With Capecitabine, Oxaliplatin, Selenomethionine, and Radiotherapy | After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically. | |
| Secondary | Safety and Tolerability as Assessed by NCI CTCAE Version 3.0 | Adverse events were queried for and collected every cycle for the duration of treatment. | Number of participants with any adverse event as assessed by NCI CTCAE version 3.0. |
| Secondary | Dose Intensity | During treatment with capecitabine, oxaliplatin, selenomethionine. | |
| Secondary | Local Relapse Rate | For up to 5 years following surgery. | |
| Secondary | Distant Relapse Rate | For up to 5 years following surgery. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Pathological Response Rate | After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically. | Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was not collected for this assessment. | ||
| PRIMARY | Rate of T-downstaging With Capecitabine, Oxaliplatin, Selenomethionine, and Radiotherapy | After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically. | Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was collected for this assessment. | ||
| SECONDARY | Safety and Tolerability as Assessed by NCI CTCAE Version 3.0 | Adverse events were queried for and collected every cycle for the duration of treatment. | All treated and eligible patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Intensity | During treatment with capecitabine, oxaliplatin, selenomethionine. | Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was collected for this assessment. | ||
| SECONDARY | Local Relapse Rate | For up to 5 years following surgery. | Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was collected for this assessment. | ||
| SECONDARY | Distant Relapse Rate | For up to 5 years following surgery. | Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was not collected for this assessment. |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability as Assessed by NCI CTCAE Version 3.0 | Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy | 5 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 5 | |
| Overall Study | COMPLETED | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 4 | |
| Overall Study | NOT COMPLETED | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 1 |
Source ClinicalTrials.gov
Adverse events39
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 | Anaemia | Blood and lymphatic system disorders | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 2 | 5 | 6 |
| other | Leukopenia | Blood and lymphatic system disorders | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 2 | 5 | 2 |
| other | Lymphopenia | Blood and lymphatic system disorders | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 5 | 5 | 15 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 2 | 5 | 2 |
| other | Constipation | Gastrointestinal disorders | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 1 | 5 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 3 | 5 | 7 |
| other | Dyspepsia | Gastrointestinal disorders | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 2 | 5 | 2 |
| other | Haemorrhoids | Gastrointestinal disorders | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 3 | 5 | 3 |
| other | Nausea | Gastrointestinal disorders | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 2 | 5 | 2 |
| other | Proctalgia | Gastrointestinal disorders | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 1 | 5 | 1 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | ||
| Total, other adverse events | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 5 | 5 |
| Total, serious adverse events | Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther | 3 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00625183
GET https://conductscience.org/api/trials/v1/NCT00625183/events?page=2