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AzTrials

Non-Small Cell Lung CancerPhase 2HYPOLANNCT02947113

Combination of Platinum Doublets and Hypofractionated Radiotherapy in NSCLC

A Phase 2 study testing Cisplatin, hypofractionated radiotherapy and Pemetrexed in people with Non-Small Cell Lung Cancer, run by The Netherlands Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Concurrent chemoradiotherapy is the standard treatment for locally advanced non-small cell lung carcinoma (NSCLC). Different chemotherapy and radiation regimens have been advocated but in general, cisplatin-doublets are deemed standard of care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Cisplatin, hypofractionated radiotherapy and Pemetrexed
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Nov 2017to Nov 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of signed, written and dated informed consent prior to any study specific procedures
  • Male or female aged 18 years or older
  • Cytological or histological proven NSCLC stage III or inoperable stage II (cT1-3-3N0-1), according to the 8th edition of the AJCC staging.
  • Patients with locoregional recurrent lung tumor following surgery or a second primary cancer are eligible, unless a pneumonectomy was performed.
  • Minimum required laboratory data
  • Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 5.5 mmol/L.
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  • Hepatic:
  • Serum bilirubin ≤ 1.5 times the upper limit of normal (× ULN); alkaline phosphatase (AP), aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) ≤ 3.0 × ULN.
  • This does not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinaemia that is predominantly unconjugated in the absence of evidence of haemolysis or hepatic pathology) who will be allowed in consultation with their physician.
  • Renal: GFR ≥ 60 ml/min; if below this threshold a creatinine clearance (CrCL) can be calculated based on the original weight based Cockcroft and Gault formula and should be ≥ 45 ml/min.

Who cannot join

  • WHO performance status ≥ 2
  • FEV-1 and DLCO < 35 % of the age- and gender adjusted normal value
  • Patients with grade 3 dyspnea or worse at baseline (according to CTCAE version 4.03)
  • Prior radiotherapy to the thorax.
  • Mean lung dose > 20.0 Gy and/or exceeding other organs-at-risk constraints (page 21).
  • Participation in another clinical study with an investigational product during the last 4 weeks.
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  • Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
  • Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of chemotherapy.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of the chemoradiotherapy or interpretation of patient safety or study results.

About this study

Official title: Feasibility Trial on Combination of Platinum Doublets and Hypofractionated Radiotherapy for Locally-advanced Stage and / or Inoperable Non-small Cell Lung Carcinoma

Concurrent chemoradiotherapy is the standard treatment for locally advanced non-small cell lung carcinoma (NSCLC). Different chemotherapy and radiation regimens have been advocated but in general, cisplatin-doublets are deemed standard of care. Decreasing the overall treatment time of irradiation by hypofractionation is thought to increase the efficacy. Extensive experience is available on the combination of daily-dose cisplatin in combination with hypofractionated radiotherapy. However, no data is available on the safety of cisplatin doublets and hypofractionated radiotherapy

Read the detailed description

Patients presenting with locally advanced NSCLC will be consented to participate in this phase 2 trial that evaluates the concurrent treatment of cisplatin (Day 1: 75mg/m2) and pemetrexed (Day 1: 500mg/m2 for non-squamous cell lung cancer) or etoposide (Day1-3 100mg/m2 for squamous cell lung cancer), 3-weekly regimens, together with radiotherapy (24 daily fractions of 2.42 Gy to the mediastinal lymph nodes with an integrated boost of 2.75 Gy to the primary tumour). An interim analysis is planned following the first cohort of 25 patients to assess safety.

Being tested
Cisplatin, hypofractionated radiotherapy, Pemetrexed, Etoposide
Keywords
cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Cisplatin will be administrated in a 3-weekly scheme for 2 courses combined with pemetrexed (non-squamous cell lung cancer) or etoposide (squamous cell lung cancer)

  • hypofractionated radiotherapyRadiation

    Hypofractionated radiotherapy of 24 x 2.75 Gy will be given combined with a 3-weekly scheme of cisplatin and pemetrexed/etoposide

  • PemetrexedDrug

    Also called Alimta

    Pemetrexed will be administrated in a combination with cisplatin and hypofractionated radiotherapy (for non-squamous cell lung cancer)

  • EtoposideDrug

    Also called Etoposin

    etoposide will be administrated in a combination with cisplatin and hypofractionated radiotherapy (for squamous cell lung cancer)

Study groups in NCT02947113
Study groupRoleWhat they receive
chemotherapy combined with radiotherapyExperimentalPatients will be treated with two 3-weekly courses of cisplatin (Day 1: 75mg/m2) and pemetrexed (Day 1: 500mg/m2 for non-squamous) or etoposide (Day1-3 100mg/m2 for squamous), together with hypofractionated radiotherapy (24 daily fractions of 2.42 Gy to the involved mediastinal lymph nodes with an integrated boost of 2.75 Gy to the primary tumor).
Receives: Drug: Cisplatin; Radiation: hypofractionated radiotherapy; Drug: Pemetrexed; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment related Adverse events (according to CTCAE v 4.03)

    safety defined by the rate of grade 3-5 adverse events

    Measured: within 3 months FU

Secondary outcomes (4)

  1. safety defined by the rate of grade 3-4 treatment related adverse events

    safety will be assessed by the incidence of grade 3-4 related adverse event (CTCAE v 4.03)

    Measured: 3 months

  2. disease control rate

    Measured: 1 year

  3. progression free survival

    Measured: 2 years

  4. overall survival

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2016 (estimated)
  2. Study startNov 2017 (estimated)
  3. Primary completionNov 2017 (estimated)
  4. Study completionNov 2017 (estimated)

Why it stopped: New studies available with immunotherapy so recruitment is no longer acceptable.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02947113
Sponsor's protocol ID
N16HYP
Other IDs
2016-003790-18, NL57625.031.16, 2016
Acronym
HYPOLAN
Status last verified
Nov 2017
First submitted
14 Oct 2016
Last updated
30 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Curran WJ Jr, Paulus R, Langer CJ, Komaki R, Lee JS, Hauser S, Movsas B, Wasserman T, Rosenthal SA, Gore E, Machtay M, Sause W, Cox JD. Sequential vs. concurrent chemoradiation for stage III non-small cell lung cancer: randomized phase III trial RTOG 9410. J Natl Cancer Inst. 2011 Oct 5;103(19):1452-60. doi: 10.1093/jnci/djr325. Epub 2011 Sep 8.

    PubMed 21903745

  • Kwint M, Uyterlinde W, Nijkamp J, Chen C, de Bois J, Sonke JJ, van den Heuvel M, Knegjens J, van Herk M, Belderbos J. Acute esophagus toxicity in lung cancer patients after intensity modulated radiation therapy and concurrent chemotherapy. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):e223-8. doi: 10.1016/j.ijrobp.2012.03.027. Epub 2012 May 5.

    PubMed 22560551

  • Mauguen A, Le Pechoux C, Saunders MI, Schild SE, Turrisi AT, Baumann M, Sause WT, Ball D, Belani CP, Bonner JA, Zajusz A, Dahlberg SE, Nankivell M, Mandrekar SJ, Paulus R, Behrendt K, Koch R, Bishop JF, Dische S, Arriagada R, De Ruysscher D, Pignon JP. Hyperfractionated or accelerated radiotherapy in lung cancer: an individual patient data meta-analysis. J Clin Oncol. 2012 Aug 1;30(22):2788-97. doi: 10.1200/JCO.2012.41.6677. Epub 2012 Jul 2.

    PubMed 22753901

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, hypofractionated radiotherapy and Pemetrexed in people with Non-Small Cell Lung Cancer, run by The Netherlands Cancer Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment related Adverse events (according to CTCAE v 4.03) (time frame: within 3 months FU). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02947113, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.

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