Combination of Platinum Doublets and Hypofractionated Radiotherapy in NSCLC (HYPOLAN)
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ClinicalTrials.gov Identifier: NCT02947113 |
Recruitment Status :
Withdrawn
(New studies available with immunotherapy so recruitment is no longer acceptable.)
First Posted : October 27, 2016
Last Update Posted : November 30, 2017
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Condition or disease | Intervention/treatment | Phase |
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Non-Small Cell Lung Cancer | Drug: Cisplatin Radiation: hypofractionated radiotherapy Drug: Pemetrexed Drug: Etoposide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Feasibility Trial on Combination of Platinum Doublets and Hypofractionated Radiotherapy for Locally-advanced Stage and / or Inoperable Non-small Cell Lung Carcinoma |
Estimated Study Start Date : | November 2017 |
Estimated Primary Completion Date : | November 2017 |
Estimated Study Completion Date : | November 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: chemotherapy combined with radiotherapy
Patients 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).
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Drug: Cisplatin
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) Radiation: hypofractionated radiotherapy Hypofractionated radiotherapy of 24 x 2.75 Gy will be given combined with a 3-weekly scheme of cisplatin and pemetrexed/etoposide Drug: Pemetrexed Pemetrexed will be administrated in a combination with cisplatin and hypofractionated radiotherapy (for non-squamous cell lung cancer)
Other Name: Alimta Drug: Etoposide etoposide will be administrated in a combination with cisplatin and hypofractionated radiotherapy (for squamous cell lung cancer)
Other Name: Etoposin |
- Incidence of treatment related Adverse events (according to CTCAE v 4.03) [ Time Frame: within 3 months FU ]safety defined by the rate of grade 3-5 adverse events
- safety defined by the rate of grade 3-4 treatment related adverse events [ Time Frame: 3 months ]safety will be assessed by the incidence of grade 3-4 related adverse event (CTCAE v 4.03)
- disease control rate [ Time Frame: 1 year ]
- progression free survival [ Time Frame: 2 years ]
- overall survival [ Time Frame: 2 years ]
- biomarker [ Time Frame: through study completion, an average of 2 years ]assessment of circulating cell free tumor DNA for residual disease

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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:
i. Serum bilirubin ≤ 1.5 times the upper limit of normal (× ULN); alkaline phosphatase (AP), aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) ≤ 3.0 × ULN.
ii. 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.
Exclusion Criteria:
- 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.
- 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.

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): NCT02947113
Principal Investigator: | Judi van Diessen, MD | The Netherlands Cancer Institute |
Responsible Party: | The Netherlands Cancer Institute |
ClinicalTrials.gov Identifier: | NCT02947113 |
Other Study ID Numbers: |
N16HYP 2016-003790-18 ( EudraCT Number ) NL57625.031.16 ( Other Identifier: CCMO ) |
First Posted: | October 27, 2016 Key Record Dates |
Last Update Posted: | November 30, 2017 |
Last Verified: | November 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
cancer |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Etoposide Pemetrexed Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |