Evidence map›Paper›PMID 30858085›Full record

Trial reportNanomedicine : nanotechnology, biology, and medicine2019

Phase I/II trial of nano-camptothecin CRLX101 with capecitabine and radiotherapy as neoadjuvant treatment for locally advanced rectal cancer.

Hanna K Sanoff, Dominic H Moon, Dominic T Moore, Jeremiah Boles, Courtney Bui, William Blackstock, Bert H O'Neil, Somasundaram Subramaniam, Autumn J McRee, Cheryl Carlson and 3 more

Abstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Nanomedicine : nanotechnology, biology, and medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  12. Cancer chemoprevention: signaling pathways and strategic approaches.Signal transduction and targeted therapy · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Hanna K SanoffLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; Department of Medicine, Division of Hematology/Oncology, University of North Carolina, Chapel Hill, NC.
Dominic H MoonLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; Department of Radiation Oncology, University of North Carolina, Chapel Hill, NC.
Dominic T MooreLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.
Jeremiah BolesRex Cancer Center, Raleigh, NC.
Courtney BuiRex Cancer Center, Raleigh, NC.
William BlackstockWake Forest Cancer Center, Winston-Salem, NC.
Bert H O'NeilIndiana University, Indianapolis, IN.
Somasundaram SubramaniamSwedish Cancer Institute, Seattle, WA.
Autumn J McReeLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; Department of Medicine, Division of Hematology/Oncology, University of North Carolina, Chapel Hill, NC.
Cheryl CarlsonLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; Department of Medicine, Division of Hematology/Oncology, University of North Carolina, Chapel Hill, NC.
Michael S LeeLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; Department of Medicine, Division of Hematology/Oncology, University of North Carolina, Chapel Hill, NC.
Joel E TepperLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; Department of Radiation Oncology, University of North Carolina, Chapel Hill, NC.
Andrew Z WangLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; Department of Radiation Oncology, University of North Carolina, Chapel Hill, NC; Laboratory of Nano- and Translational Medicine, Carolina Center for Cancer Nanotechnology Excellent, Carolina Institute of Nanomedicine, University of North Carolina, Chapel Hill, NC. Electronic address: zawang@med.unc.edu.

Funding

Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Deborah F. Tate · 1985 to 2026
$201.5M
Small Animal Imaging CoreU54CA198999 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KABANOV, ALEXANDER V · 2015 to 2019
$11.9M
Nanoparticle formulations of DNA repair inhibitors to improve chemoradiotherapyR01CA178748 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI WANG, ANDREW ZHUANG · 2013 to 2017
$1.6M
NCI NIH HHS P30 CA016086NCI NIH HHS R01 CA178748NCI NIH HHS U54 CA198999
6 · The paper itself

Abstract

CRLX101 is a nanoparticle-drug conjugate with a camptothecin payload. We assessed the toxicity and pathologic complete response (pCR) rate of CRLX101 with standard neoadjuvant chemoradiotherapy (CRT) in locally advanced rectal cancer. A single-arm study was conducted with a 3 + 3 dose escalation phase Ib followed by phase II at the maximum tolerated dose (MTD). Thirty-two patients were enrolled with 29 (91%) patients having T3/4 and 26 (81%) N1/2 disease. In phase Ib, no patient experienced a dose limiting toxicity (DLT) with every other week dosing, while 1/9 patients experienced a DLT with weekly dosing. The weekly MTD was identified as 15 mg/m

Indexed as

Neoadjuvant TherapyAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCapecitabineCohort StudiesCyclodextrinsFemaleHumansMaleMiddle AgedNanoparticlesNeoplasm StagingRectal NeoplasmsCamptothecinCapecitabineCyclodextrinsIT-101CamptothecinMaximum tolerated doseNanoparticleNeoadjuvantPathologic complete responseRectal cancer

Identifiers

PMID30858085
PMCPMC7881832

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.