Trial · NCT01324141
Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer
NCT01324141, Phase 1, Terminated, National Cancer Institute (NCI); results first posted 2021-11-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer. Trials, record NCT01324141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01324141
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer
- NCT number
- NCT01324141
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Anal Cancer
- Interventions
- Tempol, 5-Fluorouracil, Mitomycin-C, Radiation Therapy
- First posted
- 2011-03-28
- Last updated
- 2021-11-23
- Results first posted
- 2021-11-23
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Date treatment consent signed to date off study, approximately, 36 months and 10 days. | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death related to adverse event. |
| Primary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) | Date treatment consent signed to date off study, approximately, 36 months and 10 days. | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Secondary | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | baseline, weeks 1-6, follow up at 1 week, follow up at 2 weeks, and follow up at 4 weeks | RTOG grade 1-5 were used to assess skin toxicity in the groin (right and left inguinal area) and gluteal cleft, as well as two control sites. Grade 0 is no skin toxicity, Grade 1 is follicular, faint or dull erythema, Grade 3 is tender or bright erythema, Grade 3 is confluent, moist desquamation, Grade 4 is ulceration, hemorrhage, or necrosis, and Grade 5 is death due to radiation toxicity. |
| Secondary | Number of Participants That Required a Treatment Break Relative to Hematologic Toxicity (Non-dermatologic) | From beginning until completion of radiation treatment up to 46 days | Number of participants that required a treatment break relative to hematologic (e.g. thrombocytopenia, leukopenia) toxicity (non-dermatologic). |
| Secondary | Number of Participants Treated With Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) That Required Opiates | Completion of study, approximately 14 months after start of treatment | Opiates are strong drugs prescribed by prescription used for maximum pain relief. |
| Secondary | Number of Participants With 12-month Progression-free Survival Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | 12 months | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. And the appearance of one or more new lesions. |
| Secondary | Change in the Levels of Number of Human Immunodeficiency Virus (HIV) in the Circulation Pre and Post Treatment | Completion of study, approximately 14 months | Change in the levels of number of Human Immunodeficiency Virus (HIV) in the circulation pre and post treatment |
| Secondary | Ratio of the Number of Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) Cells in the Circulation and Tissue Pre and Post Treatment | Pre-treatment and post treatment tissue (CD4), and pre-treatment and post treatment circulation (CD8) | Ratio of the number Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) cells in the circulation and tissue pre and post treatment. The number of cells of CD4 are divided by the number of cells of CD8. |
| Secondary | Number of Participants With 12 Month Disease Free Survival (DFS) Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | 12 months | DFS is defined as the duration of time from start of treatment to time of progression. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. And the appearance of one or more new lesions. |
| Secondary | Overall Survival | start of treatment to time of death, approximately 14 months | OS is defined as the duration of time from start of treatment to time of death. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Date treatment consent signed to date off study, approximately, 36 months and 10 days. | 1/6 participants enrolled withdrew before treatment. | Adverse events | NUMBER |
| PRIMARY | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) | Date treatment consent signed to date off study, approximately, 36 months and 10 days. | 1/6 participants enrolled withdrew before treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | baseline, weeks 1-6, follow up at 1 week, follow up at 2 weeks, and follow up at 4 weeks | 1/6 participants enrolled withdrew before treatment. | Grade | MEAN |
| SECONDARY | Number of Participants That Required a Treatment Break Relative to Hematologic Toxicity (Non-dermatologic) | From beginning until completion of radiation treatment up to 46 days | 1/6 participants enrolled withdrew before treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Treated With Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) That Required Opiates | Completion of study, approximately 14 months after start of treatment | 1/6 participants enrolled withdrew before treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With 12-month Progression-free Survival Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | 12 months | 1/6 participants enrolled withdrew before treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in the Levels of Number of Human Immunodeficiency Virus (HIV) in the Circulation Pre and Post Treatment | Completion of study, approximately 14 months | The participants were screened for HIV before enrollment. Only 1 participant was HIV positive. However, the participant with HIV came off study before post treatment was collected so change cannot be assessed. As pre-specified in the protocol, participants are taken off study for disease progression. | ||
| SECONDARY | Ratio of the Number of Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) Cells in the Circulation and Tissue Pre and Post Treatment | Pre-treatment and post treatment tissue (CD4), and pre-treatment and post treatment circulation (CD8) | 3/6 participants were analyzed because 1 participant was enrolled but withdrew before treatment, samples were collected at the time of optional biopsy which was conducted in 3 patients. | Ratio of CD4:CD8 cells | MEAN |
| SECONDARY | Number of Participants With 12 Month Disease Free Survival (DFS) Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | 12 months | 1/6 participants enrolled withdrew before treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | start of treatment to time of death, approximately 14 months | This outcome measure could not be completed. | months | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group245
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | MTS-01 Grade 1 | Radiation dermatitis | 0 | Adverse events | |
| Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | MTS-01 Grade 2 | Radiation dermatitis | 0 | Adverse events | |
| Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | MTS-01 Grade 3 | Radiation dermatitis | 0 | Adverse events | |
| Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | 5FU/MMC/IMRT Grade 2 | Radiation dermatitis | 2 | Adverse events | |
| Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | 5-FU/MMC/IMRT Grade 3-4 | Radiation dermatitis | 3 | Adverse events | |
| Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | MTS-01 Grade 1 | Nausea | 0 | Adverse events | |
| Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | MTS-01 Grade 2 | Nausea | 0 | Adverse events | |
| Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | MTS-01 Grade 3 | Nausea | 0 | Adverse events | |
| Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | 5FU/MMC/IMRT Grade 2 | Nausea | 3 | Adverse events | |
| Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | 5-FU/MMC/IMRT Grade 3-4 | Nausea | 0 | Adverse events |
1 to 10 of 245Source ClinicalTrials.gov
See all 245 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1/Chemo + Radiation | 6 | |
| Overall Study | COMPLETED | 1/Chemo + Radiation | 4 | |
| Overall Study | NOT COMPLETED | 1/Chemo + Radiation | 2 |
Source ClinicalTrials.gov
Adverse events75
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 | Abdominal pain | Gastrointestinal disorders | 1/Chemo + Radiation | 2 | 5 | 4 |
| other | Alanine aminotransferase increased | Investigations | 1/Chemo + Radiation | 4 | 5 | 7 |
| other | Alkaline phosphatase increased | Investigations | 1/Chemo + Radiation | 1 | 5 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | 1/Chemo + Radiation | 2 | 5 | 2 |
| other | Anal hemorrhage | Gastrointestinal disorders | 1/Chemo + Radiation | 1 | 5 | 1 |
| other | Anal pain | Gastrointestinal disorders | 1/Chemo + Radiation | 1 | 5 | 2 |
| other | Anemia | Blood and lymphatic system disorders | 1/Chemo + Radiation | 4 | 5 | 8 |
| other | Anorexia | Metabolism and nutrition disorders | 1/Chemo + Radiation | 1 | 5 | 1 |
| other | Aspartate aminotransferase increased | Investigations | 1/Chemo + Radiation | 3 | 5 | 4 |
| other | Bladder spasm | Renal and urinary disorders | 1/Chemo + Radiation | 1 | 5 | 1 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1/Chemo + Radiation | 0 | 5 |
| Total, other adverse events | 1/Chemo + Radiation | 5 | 5 |
| Total, serious adverse events | 1/Chemo + Radiation | 3 | 5 |
Source ClinicalTrials.gov
Papers3
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 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/NCT01324141
GET https://conductscience.org/api/trials/v1/NCT01324141/registered?page=2