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NCT00495170

Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Completed Phase 2 Results posted Last updated 6 February 2019
What this trial tests

Phase 2 trial testing Carboplatin in Lung Cancer in 84 participants. Completed in 14 June 2017.

Timeline
14 April 2006
Primary endpoint
14 June 2017
14 June 2017

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment84
Start date14 April 2006
Primary completion14 June 2017
Estimated completion14 June 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Eligibility, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Survival and Progression Free Survival Primary · The Overall survival (OS): From date of registration to the last follow-up (f/u), or lost to f/u, or death up to 5 years. The progression free survival (PFS): From date of registration to the date of first documented progression or death up to 5 years.

The primary objective was to improve overall survival (OS). Patients are recommended to have follow up 6 weeks after completion of concurrent chemo radiotherapy for the evaluation of acute treatment toxicities, then required every 3 months (+ 1 month) for two years, then every 6 months (+ 1 month) for three years and then annually for the rest of their lives, that is standard of care. Statistics were performed with Strata/MP 14.2 software. OS was calculated by Kaplan-Meier Methodology (K-M) from the beginning of enrollment to date of death or last follow-up. Progression-free survival (PFS) w

Overall Survival at 5 years
GroupValue95% CI
Concurrent Proton and Chemotherapy29
Progression Free Survival (PFS)
GroupValue95% CI
Concurrent Proton and Chemotherapy12.9
Progression Free Survival at 5 years
GroupValue95% CI
Concurrent Proton and Chemotherapy22

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time of registration to the adverse event start date, assessed up to 5 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Concurrent Proton and Chemotherapy
Serious: 35/64 (55%)
Deaths: 47/64

Serious adverse events (58 terms)

ReactionSystemConcurrent Proton and Chem…
LeukopeniaMetabolism and nutrition disorders
PneumonitisRespiratory, thoracic and mediastinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
EsophagitisGastrointestinal disorders
FatigueGeneral disorders
DermatitisGeneral disorders
AnemiaMetabolism and nutrition disorders
DehydrationGeneral disorders
Weight lossGeneral disorders
HyponatremiaMetabolism and nutrition disorders
NeutropeniaMetabolism and nutrition disorders
CoughRespiratory, thoracic and mediastinal disorders
Pleural effusionRespiratory, thoracic and mediastinal disorders
FeverGeneral disorders
PainGeneral disorders
Pericardial effusionCardiac disorders
Esophageal strictureGastrointestinal disorders
NauseaGastrointestinal disorders
HypotensionMetabolism and nutrition disorders
PruritusGeneral disorders
RashGeneral disorders
CandidiasisSkin and subcutaneous tissue disorders
InfectionInfections and infestations
Bronchial fistulaRespiratory, thoracic and mediastinal disorders
Lobar atelectasisRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Leukopenia, Pneumonitis, Dyspnea, Esophagitis, Fatigue, Dermatitis, Anemia, Dehydration.

Data from ClinicalTrials.gov NCT00495170 adverse events section.

Sponsor's own description

The goal of this clinical research study is to learn if proton radiotherapy given with standard chemotherapy (such as paclitaxel and carboplatin) can help to control locally advanced NSCLC. The safety of this treatment will also be studied.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Proton Beam Radiotherapy and Concurrent Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer: Final Results of a Phase 2 Study.
    Chang JY, Verma V, Li M, Zhang W, et al · · 2017 · cited 116× · PMID 28727865 · DOI 10.1001/jamaoncol.2017.2032
  2. Phase 2 study of high-dose proton therapy with concurrent chemotherapy for unresectable stage III nonsmall cell lung cancer.
    Chang JY, Komaki R, Lu C, Wen HY, et al · · 2011 · cited 116× · PMID 21437893 · DOI 10.1002/cncr.26080
  3. Consensus Statement on Proton Therapy in Early-Stage and Locally Advanced Non-Small Cell Lung Cancer.
    Chang JY, Jabbour SK, De Ruysscher D, Schild SE, et al · · 2016 · cited 109× · PMID 27084663 · DOI 10.1016/j.ijrobp.2016.01.036
  4. Adaptive/nonadaptive proton radiation planning and outcomes in a phase II trial for locally advanced non-small cell lung cancer.
    Koay EJ, Lege D, Mohan R, Komaki R, et al · · 2012 · cited 54× · PMID 22543217 · DOI 10.1016/j.ijrobp.2012.02.041
  5. Radioresistance of Non-Small Cell Lung Cancers and Therapeutic Perspectives.
    Césaire M, Montanari J, Curcio H, Lerouge D, et al · · 2022 · cited 35× · PMID 35740495 · DOI 10.3390/cancers14122829
  6. FDG uptake correlates with recurrence and survival after treatment of unresectable stage III non-small cell lung cancer with high-dose proton therapy and chemotherapy.
    Xiang ZL, Erasmus J, Komaki R, Cox JD, et al · · 2012 · cited 12× · PMID 22929048 · DOI 10.1186/1748-717x-7-144
  7. Assessing the robustness of passive scattering proton therapy with regard to local recurrence in stage III non-small cell lung cancer: a secondary analysis of a phase II trial.
    Zhu Z, Liu W, Gillin M, Gomez DR, et al · · 2014 · cited 7× · PMID 24886059 · DOI 10.1186/1748-717x-9-108
  8. Particle Therapy: Clinical Applications and Biological Effects.
    Kiseleva V, Gordon K, Vishnyakova P, Gantsova E, et al · · 2022 · cited 6× · PMID 36556436 · DOI 10.3390/life12122071

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