Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer
Public ClinicalTrials.gov record NCT02010567. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase Ib/II Study of Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Locally Advanced Rectal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial will enroll patients with locally advanced rectal cancer (resectable and non-resectable).The phase Ib dose escalation portion of trial is designed to determine the maximum tolerated dose (MTD) of CRLX101 when combined with standard neoadjuvant therapies capecitabine (Cape) and radiation therapy (XRT). CRLX101 is a nanopharmaceutical (NP) formulation of camptothecin. These results will determine the recommended phase II dose (RP2D) for CRLX101 in this setting. The phase II portion of the trial is designed to evaluate the efficacy and safety of CRLX101 at the RP2D, when combined with capecitabine and radiation therapy prior to surgery.
Study identification
- NCT ID
- NCT02010567
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 32 participants
Conditions and interventions
Conditions
Interventions
- CRLX101 Drug
- Capecitabine Drug
- Radiotherapy Radiation
- Surgery Procedure
Drug · Radiation · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2013 (Type not available)
- Primary completion
- Sep 16, 2016 (Actual)
- Completion
- Jun 25, 2019 (Actual)
- Last update posted
- Nov 3, 2020
2013 – 2019
United States locations
- U.S. sites
- 6
- U.S. states
- 4
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | — |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Rex Cancer Center at Rex Hospital | Raleigh | North Carolina | 27607 | — |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02010567, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 3, 2020 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02010567 live on ClinicalTrials.gov.