Trial · NCT02010567
Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer
NCT02010567, Phase 1, Phase 2, Terminated, UNC Lineberger Comprehensive Cancer Center; results first posted 2017-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer. Trials, record NCT02010567. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02010567
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer
- NCT number
- NCT02010567
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Rectal Cancer
- Interventions
- CRLX101, Capecitabine, Radiotherapy, Surgery
- First posted
- 2013-12-12
- Last updated
- 2020-11-03
- Results first posted
- 2017-11-14
- Limitations and caveats
- Follow-up of participants was ended early, resulting in few or no observed events (progression or death) for all survival endpoints.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of CRLX101 When Added to Standard Neoadjuvant Chemoradiotherapy Consisting of Capecitabine + Radiotherapy in Locally Advanced Rectal Cancer | 12 weeks | The MTD is the highest dose of CRLX101 at which ≤1 out of 6 patients had a dose limiting toxicity (DLT) using CTCAE v4.0 toxicity criteria. DLTs include Grade (G) \>3 neutropenia for ≥7 days; G 3 or 4 neutropenia with fever; G 4 anemia not related to cancer-associated bleeding; G 4 thrombocytopenia or G 3 with clinically significant bleeding; G ≥3 nausea or vomiting \>48 hours despite anti-emetics; G 2 cystitis not resolved within 14 days; second G 2 cystitis; G 3 or 4 cystitis; diarrhea requiring dose reduction; Any other non-hematologic toxicity G ≥3 requiring a dose reduction (G ≥3 infusion-related reactions were not a DLT unless they recur despite slowing down the infusion); Other CRLX101 related treatment emergent adverse effect (TEAE) that requires patient withdrawal prior to completing all doses; Radiotherapy interruption due to TEAEs ≥5 days; or Dose interruption or reduction of capecitabine due to TEAE that results in \<50% of the scheduled capecitabine dose for entire course |
| Primary | Pathological Complete Response (pCR) Rate | 12 weeks | Primary Objective Phase II: Pathological response will be made based on microscopic assessment of the surgical specimen at the primary treatment site. A pCR must include no gross or microscopic tumor identified anywhere within the surgical specimen. This must include:No evidence of malignant cells in the primary tumor specimen and No lymph nodes that contain tumor. |
| Secondary | Pathological Response Rate | 12 weeks | Pathologic response will be made based on microscopic assessment of the surgical specimen at the primary treatment site, including regional nodes and any peritumoral satellite nodules in the specimen, and categorized as outlined below as per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 7th edition.Determination of pathological response will be reported by the local pathologist. * Pathologic Complete Response (pCR): No gross or microscopic tumor identified anywhere within the surgical specimen. This must include: No evidence of malignant cells in the primary tumor specimen and No lymph nodes that contain tumor. * Moderate response: Single cells or small groups of cancer cells * Minimal response: Residual cancer outgrown by fibrosis * Poor response:Minimal or no tumor kill; extensive residual cancer |
| Secondary | Number of Participants With Grade 3 or Higher, Treatment-related Toxicities | 12 weeks | Toxicity profile of CRLX101 when combined with capecitabine + radiotherapy to treat patients with locally advanced rectal cancer. Phase Ib and Phase II - Safety is the reported adverse event (AE) profile characterized by NCI CTCAE v4.0. The profile was limited to grade 3 or higher, treatment related AEs. |
| Secondary | Disease-free Survival (DFS) Rate | An average of 2.6 years (full range 2.1 to 3.1 years) | Phase II only - DFS will be defined as the time from surgical resection until disease recurrence or death as a result of any cause, reported as the count of participants still alive without recurrence at the end of study follow-up. |
| Secondary | Overall Survival (OS) Rate | an average of 2.6 years (full range 2.1 to 3.1 years) | Phase II only - OS is defined as the time from surgical resection until death reported as the count of participants still alive at the end of study follow-up. |
| Secondary | Disease-free Survival (DFS) Rate Based on Pathological Complete Response (pCR). | an average of 2.6 years (full range 2.1 to 3.1 years) | Phase II only - a comparison of DFS for patients who achieve pCR and those who do not. DFS will be defined as the time from surgical resection until disease recurrence or death as a result of any cause, reported as the count of participants still alive without recurrence at the end of study follow-up. |
| Secondary | Overall Survival (OS) Based on Pathological Complete Response (pCR). | an average of 2.6 years (full range 2.1 to 3.1 years) | Phase II only - a comparison of OS for patients who achieve pCR and those who do not. OS is defined as the time from surgical resection until death reported as the count of participants still alive at the end of study follow-up. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of CRLX101 When Added to Standard Neoadjuvant Chemoradiotherapy Consisting of Capecitabine + Radiotherapy in Locally Advanced Rectal Cancer | 12 weeks | Since this objective applies only to Phase Ib patients, the Phase II cohort patients were not included | mg/m^2 every other week | NUMBER |
| PRIMARY | Pathological Complete Response (pCR) Rate | 12 weeks | percentage of participants with pCR | NUMBER | |
| SECONDARY | Pathological Response Rate | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Grade 3 or Higher, Treatment-related Toxicities | 12 weeks | participants with AE | NUMBER | |
| SECONDARY | Disease-free Survival (DFS) Rate | An average of 2.6 years (full range 2.1 to 3.1 years) | 14 of 32 participants were enrolled in the Phase II portion of the study. Of these 14, one participant withdrew prior to surgery and was therefore not evaluable for this outcome | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) Rate | an average of 2.6 years (full range 2.1 to 3.1 years) | 14 of 32 participants were enrolled in the Phase II portion of the study. Of these 14, one participant withdrew prior to surgery and was therefore not evaluable for this outcome | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease-free Survival (DFS) Rate Based on Pathological Complete Response (pCR). | an average of 2.6 years (full range 2.1 to 3.1 years) | 14 of 32 participants were enrolled in the Phase II portion of the study. Of these 14, one participant withdrew prior to surgery and was therefore not evaluable for this outcome | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) Based on Pathological Complete Response (pCR). | an average of 2.6 years (full range 2.1 to 3.1 years) | 14 of 32 participants were enrolled in the Phase II portion of the study. Of these 14, one participant withdrew prior to surgery and was therefore not evaluable for this outcome | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of CRLX101 When Added to Standard Neoadjuvant Chemoradiotherapy Consisting of Capecitabine + Radiotherapy in Locally Advanced Rectal Cancer | Dose Escalation Phase Ib | 15 | mg/m^2 every other week | ||
| Pathological Complete Response (pCR) Rate | All Participants | 19 | 95% Confidence Interval 7 to 36 | percentage of participants with pCR | |
| Pathological Response Rate | All Participants | pCR | 6 | Participants | |
| Pathological Response Rate | All Participants | Moderate response | 18 | Participants | |
| Pathological Response Rate | All Participants | Minimal response | 7 | Participants | |
| Pathological Response Rate | All Participants | Unknown | 1 | Participants | |
| Number of Participants With Grade 3 or Higher, Treatment-related Toxicities | All Participants | Colitis | 1 | participants with AE | |
| Number of Participants With Grade 3 or Higher, Treatment-related Toxicities | All Participants | Dermatitis, radiation | 1 | participants with AE | |
| Number of Participants With Grade 3 or Higher, Treatment-related Toxicities | All Participants | Diarrhea | 1 | participants with AE | |
| Number of Participants With Grade 3 or Higher, Treatment-related Toxicities | All Participants | Hypophosphatemia | 1 | participants with AE |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A, Phase Ib, Dose Level 1 | 3 | |
| Overall Study | STARTED | Cohort A, Phase Ib, Dose Level 2 | 6 | |
| Overall Study | STARTED | Cohort A, Phase II, Dose Level 2 | 14 | |
| Overall Study | STARTED | Cohort B, Phase Ib, Dose Level 1, Weekly | 3 | |
| Overall Study | STARTED | Cohort B, Phase Ib, Dose Level 2, Weekly | 6 | |
| Overall Study | COMPLETED | Cohort A, Phase Ib, Dose Level 1 | 3 | |
| Overall Study | COMPLETED | Cohort A, Phase Ib, Dose Level 2 | 6 | |
| Overall Study | COMPLETED | Cohort A, Phase II, Dose Level 2 | 13 | |
| Overall Study | COMPLETED | Cohort B, Phase Ib, Dose Level 1, Weekly | 3 | |
| Overall Study | COMPLETED | Cohort B, Phase Ib, Dose Level 2, Weekly | 5 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events485
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 | Cohort A, Phase Ib, Level 1 | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort A, Phase Ib, Level 2 | 4 | 6 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort A, Phase II, Level 2 | 2 | 14 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort B, Phase Ib, Level 1 | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort B, Phase Ib, Level 2 | 3 | 6 | 3 |
| other | Alanine aminotransferase increased | Investigations | Cohort A, Phase Ib, Level 1 | 0 | 3 | 0 |
| other | Alanine aminotransferase increased | Investigations | Cohort A, Phase Ib, Level 2 | 1 | 6 | 1 |
| other | Alanine aminotransferase increased | Investigations | Cohort A, Phase II, Level 2 | 1 | 14 | 1 |
| other | Alanine aminotransferase increased | Investigations | Cohort B, Phase Ib, Level 1 | 1 | 3 | 1 |
| other | Alanine aminotransferase increased | Investigations | Cohort B, Phase Ib, Level 2 | 1 | 6 | 1 |
1 to 10 of 485Source ClinicalTrials.gov
See all 485 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A, Phase Ib, Level 1 | 0 | 3 |
| Total, all-cause mortality | Cohort A, Phase Ib, Level 2 | 0 | 6 |
| Total, all-cause mortality | Cohort A, Phase II, Level 2 | 0 | 14 |
| Total, all-cause mortality | Cohort B, Phase Ib, Level 1 | 0 | 3 |
| Total, all-cause mortality | Cohort B, Phase Ib, Level 2 | 0 | 6 |
| Total, other adverse events | Cohort A, Phase Ib, Level 1 | 3 | 3 |
| Total, other adverse events | Cohort A, Phase Ib, Level 2 | 6 | 6 |
| Total, other adverse events | Cohort A, Phase II, Level 2 | 14 | 14 |
| Total, other adverse events | Cohort B, Phase Ib, Level 1 | 3 | 3 |
| Total, other adverse events | Cohort B, Phase Ib, Level 2 | 6 | 6 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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/NCT02010567
GET https://conductscience.org/api/trials/v1/NCT02010567/events?page=2