Trial · NCT00423293
Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer
NCT00423293, Phase 2, Completed, Radiation Therapy Oncology Group; results first posted 2013-05-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer. Trials, record NCT00423293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00423293
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer
- NCT number
- NCT00423293
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Anal Cancer
- Interventions
- fluorouracil, mitomycin C, Intensity-modulated radiation therapy
- First posted
- 2007-01-18
- Last updated
- 2019-02-27
- Results first posted
- 2013-05-29
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Acute Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events) | From the start of treatment to 90 days | Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Acute toxicities occur within 90 days of the start of treatment. |
| Secondary | Number of Patients With Major Radiation Planning Deviations | Planning occurred prior to radiation therapy | Deviations in intensity-modulated radiation therapy technique (IMRT) planning were determined by central review by the radiation oncology co-chairs of the study. |
| Secondary | Percentage of Subjects With Acute Adverse Events (AE) | From the start of treatment to 90 days | Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Acute toxicities occur within 90 days of the start of treatment. |
| Secondary | Percentage of Subjects With Late Adverse Events (AE) | From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 9.2 years. | Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Late toxicities occur greater than 90 days from the start of treatment. |
| Secondary | Clinical Complete Response Rate | 8 and 12 weeks after treatment completion (corresponding to 14 and 18 weeks from registration) | A complete clinical response was defined as complete resolution of all palpable tumor determined by digital rectal exam and proctosigmoidoscopy supplemented with pelvic axial imaging. |
| Secondary | Duration of Radiotherapy Treatment | From start to end of radiation therapy (6 weeks) | Number of days from radiotherapy treatment start to radiotherapy treatment end |
| Secondary | Five-year Rate of Overall Survival | From registration to 5 years | Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. |
| Secondary | Five-year Rate of Disease-free Survival | From registration to 5 years | Disease-free survival time is defined as time from registration to the date of local-regional failure, the appearance of distant metastases, the appearance of a second primary failure, or date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact. Local failure is defined as any measurable disease after 12 weeks from the completion of chemoradiation therapy. Local failure is defined as: a) For patients with no disease in pelvic and/or groin nodes, the appearance of disease in pelvic or groin nodes; b) For patients with disease in pelvic and/or groin nodes at study entry, nodal recurrence following clearance or persistent nodal disease for more than 12 weeks after completion of treatment. |
| Secondary | Five-Year Cumulative Incidence Rate of Local-regional Failure | From registration to 5 years | Local-regional failure time is defined as time from registration to date of failure and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact. Local-regional failure is defined as a local or regional failure. Local failure is defined as any measurable disease after 12 weeks from the completion of chemoradiation therapy. Regional failure is defined as: a) For patients with no disease in pelvic and/or groin nodes, the appearance of disease in pelvic or groin nodes; b) For patients with disease in pelvic and/or groin nodes at study entry, nodal recurrence following clearance or persistent nodal disease for more than 12 weeks after completion of treatment. |
| Secondary | Five-Year Cumulative Incidence Rate of Distant Failure | From registration to 5 years | Distant failure time is defined as time from registration to the appearance of distant metastases and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Acute Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events) | From the start of treatment to 90 days | Eligible patients with adverse event information. | percentage of participants | NUMBER |
| SECONDARY | Number of Patients With Major Radiation Planning Deviations | Planning occurred prior to radiation therapy | All eligible patients who started IMRT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With Acute Adverse Events (AE) | From the start of treatment to 90 days | Eligible patients who started protocol treatment | percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects With Late Adverse Events (AE) | From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 9.2 years. | Eligible patients who started IMRT and were on-study \> 90 days from the start of treatment (or did not withdraw consent until after 90 days). | percentage of participants | NUMBER |
| SECONDARY | Clinical Complete Response Rate | 8 and 12 weeks after treatment completion (corresponding to 14 and 18 weeks from registration) | Eligible patients who started study treatment | percentage of participants | NUMBER |
| SECONDARY | Duration of Radiotherapy Treatment | From start to end of radiation therapy (6 weeks) | Eligible patients who started IMRT | Days | MEDIAN |
| SECONDARY | Five-year Rate of Overall Survival | From registration to 5 years | Eligible patients who started study treatment | percentage of participants | NUMBER |
| SECONDARY | Five-year Rate of Disease-free Survival | From registration to 5 years | Eligible patients who started study treatment | percentage of participants | NUMBER |
| SECONDARY | Five-Year Cumulative Incidence Rate of Local-regional Failure | From registration to 5 years | Eligible patients who started study treatment | percentage of participants | NUMBER |
| SECONDARY | Five-Year Cumulative Incidence Rate of Distant Failure | From registration to 5 years | Eligible patients who started study treatment | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Acute Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events) | 5-FU + Mitomycin + IMRT | 77 | 95% Confidence Interval NA to 87 | percentage of participants | |
| Number of Patients With Major Radiation Planning Deviations | 5-FU + Mitomycin + IMRT | 0 | Participants | ||
| Percentage of Subjects With Acute Adverse Events (AE) | 5-FU + Mitomycin + IMRT | GI Grade 2+ | 73 | 95% Confidence Interval NA to 83 | percentage of participants |
| Percentage of Subjects With Acute Adverse Events (AE) | 5-FU + Mitomycin + IMRT | GU Grade 2+ | 15 | 95% Confidence Interval NA to 28 | percentage of participants |
| Percentage of Subjects With Acute Adverse Events (AE) | 5-FU + Mitomycin + IMRT | Hematologic Grade 2+ | 73 | 95% Confidence Interval NA to 83 | percentage of participants |
| Percentage of Subjects With Acute Adverse Events (AE) | 5-FU + Mitomycin + IMRT | Skin Grade 2+ | 75 | 95% Confidence Interval NA to 85 | percentage of participants |
| Percentage of Subjects With Acute Adverse Events (AE) | 5-FU + Mitomycin + IMRT | Any Grade 2+ | 94 | 95% Confidence Interval NA to 99 | percentage of participants |
| Percentage of Subjects With Acute Adverse Events (AE) | 5-FU + Mitomycin + IMRT | Any Grade 3+ | 83 | 95% Confidence Interval NA to 91 | percentage of participants |
| Percentage of Subjects With Late Adverse Events (AE) | 5-FU + Mitomycin + IMRT | GI/GU Grade 2+ | 35 | 95% Confidence Interval 24 to 49 | percentage of participants |
| Percentage of Subjects With Late Adverse Events (AE) | 5-FU + Mitomycin + IMRT | Non-Hematologic Grade 2+ | 67 | 95% Confidence Interval 53 to 78 | percentage of participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5-FU + Mitomycin + IMRT | 63 | |
| Overall Study | COMPLETED | 5-FU + Mitomycin + IMRT | 52 | |
| Overall Study | NOT COMPLETED | 5-FU + Mitomycin + IMRT | 11 |
Source ClinicalTrials.gov
Adverse events177
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 | 5-FU + Mitomycin + IMRT | 35 | 52 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | 5-FU + Mitomycin + IMRT | 2 | 52 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | 5-FU + Mitomycin + IMRT | 1 | 52 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | 5-FU + Mitomycin + IMRT | 7 | 52 | |
| other | Atrial fibrillation | Cardiac disorders | 5-FU + Mitomycin + IMRT | 1 | 52 | |
| other | Cardiac disorders - Other | Cardiac disorders | 5-FU + Mitomycin + IMRT | 1 | 52 | |
| other | Paroxysmal atrial tachycardia | Cardiac disorders | 5-FU + Mitomycin + IMRT | 1 | 52 | |
| other | Sinus tachycardia | Cardiac disorders | 5-FU + Mitomycin + IMRT | 1 | 52 | |
| other | Abdominal distension | Gastrointestinal disorders | 5-FU + Mitomycin + IMRT | 2 | 52 | |
| other | Abdominal pain | Gastrointestinal disorders | 5-FU + Mitomycin + IMRT | 13 | 52 |
1 to 10 of 177Source ClinicalTrials.gov
See all 177 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5-FU + Mitomycin + IMRT | ||
| Total, other adverse events | 5-FU + Mitomycin + IMRT | 52 | 52 |
| Total, serious adverse events | 5-FU + Mitomycin + IMRT | 6 | 52 |
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/NCT00423293
GET https://conductscience.org/api/trials/v1/NCT00423293/results?page=2