Evidence map›Paper›PMID 21447969›Full record

Trial reportOncology2010

A pilot feasibility study of TNFerade™ biologic with capecitabine and radiation therapy followed by surgical resection for the treatment of rectal cancer.

Deborah Citrin, Kevin Camphausen, Bradford J Wood, Martha Quezado, John Denobile, James F Pingpank, Richard E Royal, H Richard Alexander, Geoffrey Seidel, Seth M Steinberg and 2 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
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

13 citing papers in PubMed, 29 citations in OpenAlex.

  1. Rectal Endoscopic Ultrasound in Clinical Practice.Current gastroenterology reports · 2019
    Review
  2. Review
  3. Review
  4. Review
  5. Article
  6. Endoscopic ultrasound guided interventional procedures.World journal of gastrointestinal endoscopy · 2015
    Review
  7. Review
  8. Review
  9. New horizons for cancer gene therapy.Cancer gene therapy · 2014
    Article
  10. Article
  11. Article
  12. In vivo screening of S100B inhibitors for melanoma therapy.Methods in molecular biology (Clifton, N.J.) · 2013
    Article
  13. Review
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

12 authors at 6 institutions in 1 country.

Deborah CitrinSection of Translational Radiation Oncology, Radiation Oncology Branch, Center for Cancer Research, NCI, NIH, Bethesda, MD 20892, USA. citrind@mail.nih.gov
Kevin Camphausen
Bradford J Wood
Martha Quezado
John Denobile
James F Pingpank
Richard E Royal
H Richard Alexander
Geoffrey Seidel
Seth M Steinberg
Yvonne Shuttack
Steven K Libutti
Center for Cancer Research · USScience Applications International Corporation (United States) · USMontefiore Medical Center · USNational Institutes of Health Clinical Center · USNaval Medical Research Command · USUniversity of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

Funding

Office of Collaborative BiostatisticsZIDSC007202 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI CHOO-WOSOBA, HYOYOUNG · 2009 to 2025
$14.5M
Evaluation of Novel Radiation ModifiersZIABC010849 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI CITRIN, DEBORAH · 2009 to 2012
$2.3M
CCR NIH HHS HHSN261200800001CIntramural NIH HHSNCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

objectiveThe purpose of this pilot study was to evaluate the feasibility and tolerability of weekly intratumoral TNFerade™ injections combined with concurrent capecitabine and radiotherapy in the treatment of patients with locally advanced rectal cancer.

methodsPatients with T3, T4, or N+ rectal cancer received radiotherapy to a total dose of 50.4-54 Gy in combination with capecitabine 937.5 mg/m(2) p.o. b.i.d. TNFerade™ at a dose of 4 × 10(10) particle units was injected into the rectal tumor on the first day of radiotherapy and weekly for a total of 5 injections. Surgery was performed 5-10 weeks after the completion of chemoradiation.

resultsNine patients were enrolled in this pilot trial. The stage was cT2 in 2 patients, cT3 in 6 patients, cT4 in 1 patient, N- in 7 patients and N+ in 2 patients. Eight patients completed all treatments. Grade 3 hematologic toxicity was observed in 2 patients. There was no toxicity directly attributable to the injection procedure. A complete pathologic response was observed in 2 of 9 patients.

conclusionsThis study demonstrates the feasibility of weekly intratumoral TNFerade™ injections during chemoradiotherapy for locally advanced rectal cancer. Pathologic responses with this combination compare favorably to published rates.

Indexed as

Genetic TherapyAdultCapecitabineCombined Modality TherapyDeoxycytidineFeasibility StudiesFemaleFluorouracilHumansMaleMiddle AgedNeoadjuvant TherapyPilot ProjectsRectal NeoplasmsTumor Necrosis Factor-alphaCapecitabineDeoxycytidineFluorouracilTumor Necrosis Factor-alpha

Identifiers

PMID21447969
PMCPMC3078259
OpenAlexW2047245666

What OpenQuestion holds

Textmetadata
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.