Status:

WITHDRAWN

Standard of Care Lifestyle Support for Stage III NSCLC Patients

Lead Sponsor:

Maastricht Radiation Oncology

Conditions:

Non Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Brief Summary

Offering an early-initiated supportive care program to stage III NSCLC patients to prevent deterioration of performance status and increase compliance of patients that complete chemoradiation as well ...

Detailed Description

In inoperable Stage III Non-Small Cell Lung Cancer (NSCLC), consolidation immune checkpoint inhibition with the PD-L1 inhibitor durvalumab, given within 6 weeks after completion of concurrent platinum...

Eligibility Criteria

Inclusion

  • Pathological diagnosis of adequately staged (according to standard practice using chest-CT, FDG-PET, brain imaging MRI/CT) NSCLC
  • Participant is willing and able to give informed consent for participation in the trial
  • Aged 18 years or above
  • Scheduled to receive one of the following two therapeutic strategies:
  • Concurrent chemotherapy and radiotherapy with photons (60 Gy in 30 fractions of 2 Gy) followed by durvalumab in patients with stage III NSCLC
  • Concurrent chemotherapy and radiotherapy with protons (60 Gy in 30 fractions of 2 Gy) followed by durvalumab in patients with stage III NSCLC
  • Able and willing to comply with all trial requirements

Exclusion

  • Mixed non-small cell lung cancer with other histology such as small cell lung cancer
  • Not able to comply with the study protocol
  • Less than 18 years old
  • Pregnancy or not able to comply with adequate contraception in women with child baring potential
  • Previous radiotherapy to the chest for benign or malignant conditions, including radiation for breast cancer
  • Previous malignancy treated with chemotherapy, immune therapy or radiotherapy (irrespective of when this happened)
  • Previous malignancies treated with surgery only are allowed if 2 years or more before inclusion in the present study

Key Trial Info

Start Date :

August 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 1 2025

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT05287971

Start Date

August 1 2023

End Date

May 1 2025

Last Update

September 6 2023

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