Evidence map›Paper›PMID 20572040›Full record

Trial reportCancer2010

Long-term results of a phase 2 study of neoadjuvant chemotherapy and radiotherapy in the management of high-risk, high-grade, soft tissue sarcomas of the extremities and body wall: Radiation Therapy Oncology Group Trial 9514.

William G Kraybill, Jonathan Harris, Ira J Spiro, David S Ettinger, Thomas F DeLaney, Ronald H Blum, David R Lucas, David C Harmon, G Douglas Letson, Burton Eisenberg

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00002791 (A PHASE II STUDY OF NEOADJUVANT CHEMOTHERAPY AND RADIATION THERAPY IN THE MANAGEMENT OF HIGH-RISK, HIGH-GRADE, SOFT TISSUE SARCOMAS OF THE EXTREMITIES AND BODY WALL), which is not on this map. Cited by 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 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.

NCT00002791 phase2completednot on this map

A phase ii study of neoadjuvant chemotherapy and radiation therapy in the management of high-risk, high-grade, soft tissue sarcomas of the extremities and body wall

TypeinterventionalSponsorRadiation Therapy Oncology GroupRan1997 to 2013ConditionsSarcomaArmsfilgrastim, dacarbazine, doxorubicin hydrochloride, ifosfamide, mesna
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Soft Tissue Sarcoma, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2022
    Guideline
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  12. Pleomorphic rhabdomyosarcoma of the vagina: A case report.World journal of clinical cases · 2024
    Article
  13. Review
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  16. Preoperative radiotherapy with concomitant chemotherapy in extremity soft tissue sarcomas: long-term results of a single center.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2023
    Article
  17. Article
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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

10 authors.

William G KraybillDepartment of Surgery, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute and Comprehensive Cancer Center, Ohio State University, Columbus, Ohio 43210, USA. william.kraybill@osumc.edu
Jonathan Harris
Ira J Spiro
David S Ettinger
Thomas F DeLaney
Ronald H Blum
David R Lucas
David C Harmon
G Douglas Letson
Burton Eisenberg

Funding

RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
RTOG Foreign AccrualsU10CA037422 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI BRUNER, DEBORAH WATKINS · 1985 to 2013
$30.4M
RADIATION THERAPY ONCOLOGY GROUP-STATISTICAL UNIT GRANTU10CA032115 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI SADEK, RAMSES · 1985 to 2008
$9.4M
NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA032115NCI NIH HHS U10 CA037422NCI NIH HHS U10 CA21661NCI NIH HHS U10 CA32115NCI NIH HHS U10 CA37422
6 · The paper itself

Abstract

backgroundThe use of neoadjuvant and adjuvant chemotherapy in soft tissue sarcomas is controversial. This is a report of long-term (≥5 years) follow-up in patients with high-grade, high-risk soft tissue sarcomas treated with neoadjuvant chemotherapy, preoperative radiotherapy (RT), and adjuvant chemotherapy.

methodsPatients with high-grade soft tissue sarcoma≥8 cm in diameter of the extremities and body wall received 3 cycles of neoadjuvant chemotherapy (mesna, doxorubicin, ifosfamide, and dacarbazine) and preoperative RT (44 grays administered in split courses), and 3 cycles of postoperative chemotherapy (mesna, doxorubicin, ifosfamide, and dacarbazine).

resultsSixty-four of 66 patients were analyzed. After chemotherapy and RT, 61 patients had surgery; 58 had R0 resections (5 amputations), and 3 had R1 resections. Ninety-seven percent experienced grade 3 or higher toxicity, including 3 deaths. These toxicities were short term. With a median follow-up of 7.7 years in surviving patients, the 5-year rates of locoregional failure (including amputation), and distant metastasis were 22.2% (95% confidence interval [CI], 11.8-32.6) and 28.1% (95% CI, 17.0-39.2). The most common site of metastasis was lung. Estimated 5-year rates of disease-free survival, distant disease-free survival, and overall survival were 56.1% (95% CI, 43.9-68.3), 64.1% (95% CI, 52.3-75.8), and 71.2% (95% CI, 60.0-82.5), respectively.

conclusionsAlthough the toxicity was significant, it was limited in its course and for the most part resolved by 1 year. The long-term outcome was better than might be expected in such high-risk tumors.

Indexed as

Abdominal WallExtremitiesNeoadjuvant TherapyThoracic WallAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, AdjuvantCombined Modality TherapyHumansRadiotherapy, AdjuvantRiskSoft Tissue NeoplasmsTreatment Outcome

Identifiers

PMID20572040
PMCPMC3780573

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Registered trials

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.