Trial · NCT02641691
Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum
NCT02641691, Phase 2, Completed, Washington University School of Medicine; results first posted 2021-02-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum. Trials, record NCT02641691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02641691
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum
- NCT number
- NCT02641691
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Cancer of Rectum, Cancer of the Rectum, Neoplasm, Rectum, Rectal Cancer, Rectum Cancer, Rectum Neoplasms, Adenocarcinoma of the Rectum
- Interventions
- Radiation, Oxaliplatin, Leucovorin, Fluorouracil
- First posted
- 2015-12-29
- Last updated
- 2021-02-18
- Results first posted
- 2021-02-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate | 1 year | * Criteria for complete clinical response: * No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer * No radiographic evidence of tumor on DRE * Substantial downsizing on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment) * Criteria for no significant clinical response: * Residual disease by DRE, endoscopy or MR. * Increase in primary tumor size upon clinical exam or imaging * Any new lesions |
| Secondary | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Baseline | -The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much). |
| Secondary | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Completion of chemoradiation (approximately 112 days) | -The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much). |
| Secondary | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | 10-14 months after chemoradiation (approximately 16-20 months) | -The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much). |
| Secondary | Number of Any Grade 3 or Higher Toxicities | From start of radiation treatment through 30 days after completion of treatment (approximately 18 weeks) | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. |
| Secondary | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Post-chemotherapy through 1 year follow-up (approximately 1 year and 4 months) | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. |
| Secondary | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | Baseline | -The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much) |
| Secondary | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | Completion of chemoradiation (approximately 112 days) | -The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much) |
| Secondary | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | 10-14 months after chemoradiation (approximately 16-20 months) | -The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much) |
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 | Complete Response Rate | 1 year | 1 participant was not evaluable for this outcome measure as they were removed for an adverse event | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Baseline | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Completion of chemoradiation (approximately 112 days) | One participant was not evaluable for this outcome measure because they did not complete chemoradiation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | 10-14 months after chemoradiation (approximately 16-20 months) | One participant was not evaluable for this outcome measure because they did not complete chemoradiation. One participant was not evaluable for this outcome measure because they expired prior to this timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Any Grade 3 or Higher Toxicities | From start of radiation treatment through 30 days after completion of treatment (approximately 18 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Post Chemotherapy Grade 3 or Higher Toxicities | Post-chemotherapy through 1 year follow-up (approximately 1 year and 4 months) | One participant was not evaluable for this outcome measure because they did not complete chemoradiation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | Baseline | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | Completion of chemoradiation (approximately 112 days) | One participant was not evaluable for this outcome measure because they did not complete chemoradiation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quality of Anorectal Function as Measured by the FACT-C Questionnaire | 10-14 months after chemoradiation (approximately 16-20 months) | One participant was not evaluable for this outcome measure because they did not complete chemoradiation. One participant was not evaluable for this outcome measure because they expired prior to this timepoint. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group745
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response Rate | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 12 | Participants | ||
| Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | 0=Not at All | I have a lack of energy | 9 | Participants | |
| Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | 1=A Little Bit | I have a lack of energy | 3 | Participants | |
| Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | 2=Somewhat | I have a lack of energy | 6 | Participants | |
| Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | 3=Quite a Bit | I have a lack of energy | 2 | Participants | |
| Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | 4=Very Much | I have a lack of energy | 0 | Participants | |
| Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | Prefer Not to Answer/No Answer/No | I have a lack of energy | 0 | Participants | |
| Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | 0=Not at All | I have nausea | 19 | Participants | |
| Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | 1=A Little Bit | I have nausea | 0 | Participants | |
| Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire | 2=Somewhat | I have nausea | 1 | Participants |
1 to 10 of 745Source ClinicalTrials.gov
See all 745 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 20 | |
| Overall Study | COMPLETED | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 20 | |
| Overall Study | NOT COMPLETED | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 0 |
Source ClinicalTrials.gov
Adverse events58
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 | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 3 | 20 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 1 | 20 | |
| other | Ventricular fibrillation | Cardiac disorders | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 1 | 20 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 2 | 20 | |
| other | Constipation | Gastrointestinal disorders | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 1 | 20 | |
| other | Diarrhea | Gastrointestinal disorders | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 5 | 20 | |
| other | Mucositis oral | Gastrointestinal disorders | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 1 | 20 | |
| other | Nausea | Gastrointestinal disorders | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 1 | 20 | |
| other | Rectal pain | Gastrointestinal disorders | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 1 | 20 | |
| other | Fatigue | General disorders | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 4 | 20 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 1 | 20 |
| Total, other adverse events | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 20 | 20 |
| Total, serious adverse events | Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU | 8 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34001462 | DERIVED |
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 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/NCT02641691
GET https://conductscience.org/api/trials/v1/NCT02641691/results?page=2