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Elderly With Locally Advanced Lung Cancer: Deciding Through Geriatric Assessment on the Optimal Treatment Strategy (ELDAPT)

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ClinicalTrials.gov Identifier: NCT02284308
Recruitment Status : Recruiting
First Posted : November 6, 2014
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Brief Summary:
There is no detailed information available on benefits and harms of intensified treatment with concurrent RCHT among a subpopulation of elderly patients. Reliable tools are needed to distinguish the subgroup of fit patients from frail patients.

Condition or disease Intervention/treatment Phase
NSCLC Other: Blood withdrawal Not Applicable

Detailed Description:
Lung cancer is a problem of the elderly: 30% of the lung cancer patients are aged ≥ 75 years. Due to underrepresentation of elderly patients in clinical trials there is a lack of evidence to select the optimal treatment strategy for these patients. Concurrent radiochemotherapy (RCHT) has been recognised as the standard treatment of stage III NSCLC patients with a good performance status. Evidence for this treatment was gained in clinical trials that mostly excluded elderly patients. Furthermore, the survival gain obtained with combined RCHT, comes with a significant increase in toxicity. Therefore, information on benefits and harms of intensified treatment with concurrent RCHT among a subpopulation of medically fit elderly patients is still lacking. Moreover, reliable tools are needed to distinguish the subgroup of fit patients from frail patients, i.e. those expected to experience important toxicity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ELDAPT: Elderly With Locally Advanced Lung Cancer: Deciding Through Geriatric Assessment on the oPtimal Treatment Strategy
Study Start Date : July 2016
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Concurrent RCHT
  1. Etoposide (day 1, 2 and 3) and cisplatin (day 1) every 3 weeks, 3 cycles)
  2. Etoposide (day 1, 2 and 3) and carboplatin (every 3 weeks, 3 cycles)
  3. Cisplatin (daily)
  4. Pemetrexed/Alimta and cisplatin (day 1 every 3 weeks, 3 cycles)
  5. Pemetrexed/Alimta and carboplatin (day 1 every 3 weeks, 3 cycles)

Radiation schedule:

Radiotherapy in both arms is delivered to a minimal total tumour dose (TTD) of 66 Gy (biologically equivalent dose (EQD2), corrected for overall treatment time), unless restricted by one of the normal tissue constraints (see below). In the latter case, the mininimal TTD (EQD2 corrected for overall treatment time) is 60 Gy. Possible RT schedules include 33*2 Gy (once daily), 24*2.75 Gy (once daily) or RT according to an individualized prescribed maximal tolerated dose protocol (once or twice daily). The maximal allowed TTD (EQD2) is 86 Gy, corrected for overall treatment time. The overall treatment time should be no more than 47 days.

Other: Blood withdrawal
An extra withdrawal of blood, during a routine blood withdrawal. This is an optional inverventions for patients.

Active Comparator: Sequential RCHT
  1. Pemetrexed/Alimta and cisplatin day 1 every 3 weeks, 3 cycles,
  2. Pemetrexed/Alimta and carboplatin (every 3 weeks, 3 cycles),
  3. Gemcitabine (day 1 and 8) and cisplatin (day 1) every 3 weeks, 3 cycles)
  4. Gemcitabine (day 1 and 8) and carboplatin, (day 1 every 3 weeks, 3 cycles)

Radtiation schedule:

Radiotherapy in both treatment arms is delivered to a minimum total tumour dose (TTD) of 66 Gy (biologically equivalent dose (EQD2), corrected for overall treatment time), unless restricted by one of the normal tissue constraints (see below). In the latter case, the minimum TTD (EQD2 corrected for overall treatment time) is 60 Gy. Possible RT schedules include 33*2 Gy (once daily), 24*2.75 Gy (once daily) or RT according to an individualized prescribed maximal tolerated dose protocol (once or twice daily). The maximal allowed TTD (EQD2) is 86 Gy, corrected for overall treatment time. The overall treatment time should be no more than 47 days.

Other: Blood withdrawal
An extra withdrawal of blood, during a routine blood withdrawal. This is an optional inverventions for patients.




Primary Outcome Measures :
  1. QAS (quality adjusted survival) [ Time Frame: yearly until death (average 10 years) ]
    To compare concurrent and sequential RCHT with respect to quality-adjusted survival (QAS) in elderly patients (≥75 years) with stage III NSCLC


Secondary Outcome Measures :
  1. Geriatric assessment [ Time Frame: Baseline ]
    To perform geriatric assessment in stage III NSCLC patients to select patients fit enough to undergo intensified treatment

  2. Reliable predictive elements [ Time Frame: 5 years ]
    To identify reliable elements of the geriatric assessment that are predictive for treatment tolerance and QAS in elderly patients with stage III NSCLC

  3. Predictive value [ Time Frame: 5 years ]
    To determine the predictive value of blood biomarkers, cardiac ejection fraction and physical performance measures with respect to treatment tolerance and QAS in elderly patients with stage III NSCLC

  4. Development and validation of geriatric screening instrument [ Time Frame: 5 years ]
    To develop and validate a clinically applicable geriatric screening instrument that enables appropriate treatment stratification in the elderly NSCLC patient

  5. Medical comparison between treatments [ Time Frame: 5 years ]
    To compare concurrent and sequential RCHT in fit elderly patients with respect to overall and progression free survival

  6. Cost-effectiveness [ Time Frame: End of study ]
    To compare cost-effectiveness of sequential and concurrent RCHT for fit elderly patients with stage III NSCLC

  7. Medical comparison between treatments with respect to preservation of functional capacity/independence [ Time Frame: 5 years ]
    To compare concurrent and sequential RCHT in fit elderly patients with respect to preservation of functional capacity/independence

  8. Medical comparison between treatments with respect to overall and lung-cancer specific QOL [ Time Frame: 5 years ]
    Tom compare concurrent and sequential RCHT in fit elderly patients with respect to overall and lung-cancer specific Qol



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any subtype of NSCLC, primary UICC stage III
  • Age ≥ 75 years

Exclusion Criteria:

  • Not any subtype of NSCLC, primary UICC stage III
  • Younger than 75 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284308


Contacts
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Contact: Judith van Loon, MD, PhD +31 88 44 55 666 judith.vanloon@maastro.nl
Contact: Nadja Drummen +31 88 44 55 817 nadja.drummen@maastro.nl

Locations
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Belgium
University Hospital Gent Not yet recruiting
Gent, Belgium, 9000
Contact: Veerle Surmont         
Netherlands
Radiotherepiegroep Recruiting
Arnhem, Gelderland, Netherlands, 6815 AD
Principal Investigator: Marcel Stam         
Caniusius-Wilhelmina Hospital Recruiting
Nijmegen, Gelderland, Netherlands, 6532 SZ
Principal Investigator: Yvonne Berk         
Ziekenhuisgroep Twente Recruiting
Almelo, Overijssel, Netherlands, 7609 PP
Principal Investigator: Jeske Staal         
Deventer Hospital Recruiting
Deventer, Overijssel, Netherlands, 7416 SE
Principal Investigator: Suzy Samii         
Radiotherapiegroep Recruiting
Deventer, Overijssel, Netherlands, 7416 SE
Principal Investigator: Ernest Vonk         
Gelre ziekenhuis Recruiting
Apeldoorn, Netherlands
Contact: N Pronk, Dr.         
Principal Investigator: N Pronk         
Rijnstate Ziekenhuis Recruiting
Arnhem, Netherlands, 6815 AD
Contact: Niels Claessens         
Amphia Ziekenhuis Not yet recruiting
Breda, Netherlands, 4818 CK
Contact: Joachim Aerts         
Medical Centre Haaglanden Recruiting
Den Haag, Netherlands, 2512 VA
Contact: Klaar Maas         
Catharina Hospital Eindhoven Recruiting
Eindhoven, Netherlands, 5623 EJ
Contact: Ben van den Borne         
Zuyderland Recruiting
Heerlen, Netherlands, 6419 PC
Principal Investigator: Gerben Bootsma         
Leiden University Medical Centre Not yet recruiting
Leiden, Netherlands, 2333 ZC
Contact: Rajen Ramai         
MAASTRO clinic Recruiting
Maastricht, Netherlands, 6229 ET
Contact: Judith van Loon, MD, PhD    +31 88 44 55 666    judith.vanloon@maastro.nl   
Contact: Nadja Drummen    +31 88 44 55 817    nadja.drummen@maastro.nl   
Principal Investigator: Judith van Loon         
Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Anne-Marie Dingemans, MD, PhD    +31 43 387 65 43    a.dingemans@maastro.nl   
Principal Investigator: Anne-Marie Dingemans         
University Medical Centre Nijmegen Recruiting
Nijmegen, Netherlands, 6525 GA
Principal Investigator: Olga Schuurbiers         
Laurentius Hospital Recruiting
Roermond, Netherlands, 6043 VC
Contact: Cordula Pitz         
VieCuri Medical Centre Recruiting
Venlo, Netherlands, 5912 BL
Contact: Marcel Westenend         
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
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Principal Investigator: Judith van Loon, MD, PhD MAASTRO clinic (radiotherapist)
Principal Investigator: Anne-Marie Dingemans, MD, PhD azM/MUMC (pulmonologist)
Principal Investigator: Mariska Janssen-Heijnen, PhD VieCuri Medical Centre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT02284308     History of Changes
Other Study ID Numbers: ELDAPT
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maastricht Radiation Oncology:
NSCLC