Trial · NCT00807911
Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer
NCT00807911, Phase 2, Completed, Asan Medical Center; results first posted 2024-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer. Trials, record NCT00807911. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00807911
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer
- NCT number
- NCT00807911
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 322 participants, actual
- Lead sponsor
- Asan Medical Center
- Conditions
- Rectal Cancer
- Interventions
- Adjuvant FL, Adjuvant FOLFOX
- First posted
- 2008-12-12
- Last updated
- 2024-10-23
- Results first posted
- 2024-10-23
- Limitations and caveats
- not specific
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Disease Recurrence | up to 3 years after completion of treatment | Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria |
| Primary | Number of Participants With Disease Recurrence With Pathological Stage III | up to 3 years after completion of treatment | Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria. |
| Primary | Number of Participants With Disease Recurrence With Pathological Stage II | up to 3 years after completion of treatment | Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria. |
| Secondary | Death Rate | Up to 3 years after completion of treatment. | overall survival was defined as the time from randomisation to death. We used the Kaplan-Meier method to estimate disease-free and overall survival. Patients were censored at the last follow-up if they were alive and free from disease recurrence. We used the log-rank test to compare the two survival distributions. We estimated crude and stratified hazard ratios (HRs) and their corresponding 95% CIs using the Cox proportionalhazards regression model. |
| Secondary | Pattern of Recurrence | the time from the date of randomization to the date of disease relapse, , assessed up to 5 years | After the completion of study treatment, chest radiography and measurement of carcinoembryonic antigen were done every 3 months for the fi rst 2 years and every 6 months thereafter. Abdominopelvic CT scans were done every 6 months and chest CT scans annually. Colonoscopy was scheduled at 1 year, 3 years, and 5 years from the date of surgery. Local recurrence was defined as any clinically proven tumour relapse within the pelvis or perineum. Distant metastasis was defined as relapse at any other site rather than local recurrence. We regarded any local or distant recurrence as a disease recurrence event. Disease recurrence was judged by the investigators with no central review. |
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 | Number of Participants With Disease Recurrence | up to 3 years after completion of treatment | intention-to-treat population (all randomised patients) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Disease Recurrence With Pathological Stage III | up to 3 years after completion of treatment | Among intention-to-treat population (all randomised patients), Patients with pathological stage III disease | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Disease Recurrence With Pathological Stage II | up to 3 years after completion of treatment | Among intention-to-treat population (all randomised patients), Patients with pathological stage II disease | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Death Rate | Up to 3 years after completion of treatment. | intention-to-treat population (all randomised patients) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pattern of Recurrence | the time from the date of randomization to the date of disease relapse, , assessed up to 5 years | intention-to-treat population (all randomised patients) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Disease Recurrence | Adjuvant Fluorouracil +Leucovorin | 53 | Participants | ||
| Number of Participants With Disease Recurrence | Adjuvant FOLFOX | 39 | Participants | ||
| Number of Participants With Disease Recurrence With Pathological Stage III | Adjuvant Fluorouracil +Leucovorin | 38 | Participants | ||
| Number of Participants With Disease Recurrence With Pathological Stage III | Adjuvant FOLFOX | 29 | Participants | ||
| Number of Participants With Disease Recurrence With Pathological Stage II | Adjuvant Fluorouracil +Leucovorin | 15 | Participants | ||
| Number of Participants With Disease Recurrence With Pathological Stage II | Adjuvant FOLFOX | 10 | Participants | ||
| Death Rate | Adjuvant Fluorouracil +Leucovorin | 21 | Participants | ||
| Death Rate | Adjuvant FOLFOX | 10 | Participants | ||
| Pattern of Recurrence | Adjuvant Fluorouracil +Leucovorin | Any event | 53 | Participants | |
| Pattern of Recurrence | Adjuvant FOLFOX | Any event | 39 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adjuvant Fluorouracil +Leucovorin | 161 | |
| Overall Study | STARTED | Adjuvant FOLFOX | 160 | |
| Overall Study | COMPLETED | Adjuvant Fluorouracil +Leucovorin | 149 | |
| Overall Study | COMPLETED | Adjuvant FOLFOX | 146 | |
| Overall Study | NOT COMPLETED | Adjuvant Fluorouracil +Leucovorin | 12 | |
| Overall Study | NOT COMPLETED | Adjuvant FOLFOX | 14 |
Source ClinicalTrials.gov
Adverse events26
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 | Leucopenia | Blood and lymphatic system disorders | Fluorouracil+Leucovorin Group | 33 | 149 | |
| other | Leucopenia | Blood and lymphatic system disorders | FOLFOX Group | 47 | 146 | |
| other | neutropenia | Blood and lymphatic system disorders | Fluorouracil+Leucovorin Group | 68 | 149 | |
| other | neutropenia | Blood and lymphatic system disorders | FOLFOX Group | 102 | 146 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Fluorouracil+Leucovorin Group | 4 | 149 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | FOLFOX Group | 1 | 146 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Fluorouracil+Leucovorin Group | 3 | 149 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | FOLFOX Group | 38 | 146 | |
| other | Anemia | Blood and lymphatic system disorders | Fluorouracil+Leucovorin Group | 3 | 149 | |
| other | Anemia | Blood and lymphatic system disorders | FOLFOX Group | 3 | 146 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluorouracil+Leucovorin Group | 21 | 161 |
| Total, all-cause mortality | FOLFOX Group | 10 | 160 |
| Total, other adverse events | Fluorouracil+Leucovorin Group | 149 | 149 |
| Total, other adverse events | FOLFOX Group | 146 | 146 |
| Total, serious adverse events | Fluorouracil+Leucovorin Group | 0 | 149 |
| Total, serious adverse events | FOLFOX Group | 0 | 146 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adjuvant Fluorouracil +Leucovorin vs Adjuvant FOLFOX: Death Rate | Trial comparisons |
| Adjuvant Fluorouracil +Leucovorin vs Adjuvant FOLFOX: Number of Participants With Disease Recurrence With Pathological Stage III | Trial comparisons |
| Adjuvant Fluorouracil +Leucovorin vs Adjuvant FOLFOX: Number of Participants With Disease Recurrence | Trial comparisons |
| Adjuvant Fluorouracil +Leucovorin vs Adjuvant FOLFOX: Number of Participants With Disease Recurrence With Pathological Stage II | Trial comparisons |
| Fluorouracil+Leucovorin Group vs FOLFOX Group: deaths from any cause | Trial comparisons |
| Fluorouracil+Leucovorin Group vs FOLFOX Group: 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/NCT00807911
GET https://conductscience.org/api/trials/v1/NCT00807911/results?page=2