Evidence map›Paper›PMID 29248169›Full record

Trial reportInternational journal of radiation oncology, biology, physics2018

Simultaneous Integrated Boost for Radiation Dose Escalation to the Gross Tumor Volume With Intensity Modulated (Photon) Radiation Therapy or Intensity Modulated Proton Therapy and Concurrent Chemotherapy for Stage II to III Non-Small Cell Lung Cancer: A Phase 1 Study.

Melenda D Jeter, Daniel Gomez, Quynh-Nhu Nguyen, Ritsuko Komaki, Xiaodong Zhang, Xiaorong Zhu, Michael O'Reilly, Frank V Fossella, Ting Xu, Xiong Wei and 5 more

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

Trial report in International journal of radiation oncology, biology, physics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing 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.

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

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

  1. Pooled it
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  4. Observational
  5. Review
  6. Article
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  9. Review
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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

15 authors.

Melenda D JeterDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: mdjeter@mdanderson.org.
Daniel GomezDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Quynh-Nhu NguyenDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Ritsuko KomakiDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Xiaodong ZhangDepartment of Medical Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Xiaorong ZhuDepartment of Medical Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Michael O'ReillyDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Frank V FossellaDepartment of Thoracic Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Ting XuDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Xiong WeiDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Hui WangDepartment of Radiation Oncology, Key Laboratory of Translational Radiation Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan Province, People's Republic of China.
Wenjuan YangDepartment of Radiation Oncology, Key Laboratory of Translational Radiation Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan Province, People's Republic of China.
Anne TsaoDepartment of Thoracic Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Radhe MohanDepartment of Medical Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Zhongxing LiaoDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Statistics, Data Exchange, Management and SupportP01CA021239 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI DELANEY, THOMAS F · 1985 to 2013
$28.3M
MDACC Clinical and Research Physics SupportU19CA021239 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI MOHAN, RADHE · 2014 to 2018
$11.2M
NCI NIH HHS P01 CA021239NCI NIH HHS P30 CA016672NCI NIH HHS U19 CA021239
6 · The paper itself

Abstract

purposeTo establish, in the phase 1 portion of a prospective phase 1/2 study, the maximum tolerated dose of image guided intensity modulated radiation therapy (IMRT) or proton therapy (IMPT), both with a simultaneous integrated boost (SIB), for patients with stage II to IIIB non-small cell lung cancer receiving concurrent chemoradiation therapy. METHODS AND MATERIALS: Patients had pathologically proven non-small cell lung cancer, either unresectable stage II to IIIB disease or recurrent disease after surgical resection, and could tolerate concurrent chemoradiation. Radiation doses were selectively escalated to the SIB volume (internal gross tumor volume + 5-mm margin), and the dose to the planning target volume (internal gross tumor volume + 8-mm margin for clinical target volume + 5 mm) was kept at 60 Gy [cobalt gray equivalent (CGE)] over 30 fractions. Patients were randomized between the IMRT and IMPT groups if slots were available on the treatment machines for both groups. Otherwise, patients were allocated to IMRT or IMPT, whichever had an open treatment slot on the machine without randomization.

resultsFifteen patients (6 IMRT, 9 IMPT) were enrolled. The highest doses to the SIB were 72 Gy in the IMRT group and 78 Gy(CGE) in the IMPT group. Nine patients (6 IMRT, 3 IMPT) received an SIB dose of 72 Gy(CGE) [biologically effective dose = 89.3 Gy(CGE)], and 6 patients (IMPT) received an SIB dose of 78 Gy(CGE) [biologically effective dose = 98.3 Gy(CGE)]. Dose-limiting (grade ≥3) toxicity (esophagitis) developed in 1 of the 9 patients given 72 Gy(CGE) SIB. Grade ≥3 pneumonitis developed in 2 of the 6 patients treated to 78 Gy(CGE) IMPT SIB: 1 (grade 3) at 3 months after treatment and the other (grade 5, possibly related to treatment) at 2 months after treatment. Only 1 patient developed a marginal tumor recurrence with a median follow-up of 25 months (range, 4.3-47.4 months).

conclusionsWe recommend that an SIB dose of 72 Gy(CGE) be used as the highest SIB dose for the planned randomized phase 2 study.

Indexed as

AgedAged, 80 and overCarcinoma, Non-Small-Cell LungChemoradiotherapyDose Fractionation, RadiationFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalPneumoniaProspective StudiesProton TherapyRadiotherapy DosageRadiotherapy, Image-Guided

Identifiers

PMID29248169
PMCPMC5846341

What OpenQuestion holds

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Registered trials

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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.