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

Maastricht Radiation Oncology

Status: Active, not recruiting

Conditions: NSCLC

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02284308

ELDAPT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Any subtype of pathologically proven NSCLC, primary UICC Stage III disease;
• Age ≥ 75 years;
• No surgery or adjuvant chemotherapy for NSCLC in the last year;
• No prior radiotherapy to the ipsilateral thorax or mediastinum;
• No clinical superior vena cava syndrome;
• No diagnosis of other cancer within the last 3-years (except in situ carcinoma's and / or non-melanoma skin cancer);
• Written informed consent

Trial design

180 participants in 1 patient group

Patients with any subtype of NSCLC, primary UICC Stage III, age ≥ 75 years

Description:

All registered patients will undergo a geriatric assessment to assess vulnerability. Based on this assessment, patients are offered treatment according to the discretion of the physician and patient.