Clinical trial NCT02421718: Standard Follow-up Program (SFP) for Lung Cancer Patients Treated With Radiotherapy or Chemoradiation
Official title: Standard Follow-up Program (SFP) for Lung Cancer Patients Treated With Radiotherapy or Chemoradiation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: Acute toxicity
Late toxicity
Prediction models
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer - Limited Disease (SCLC-LD) or thymoma or lungmetastases (treated with stereotactic radiotherapy), receiving radiotherapy dose \> 40 Gy.

Brief summary: Motive:

In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from lung cancer patients.

Goal:

To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with NSCLC or SCLC-LD or thymoma or lung metastases (treated with stereotactic radiotherapy)
* Patients receiving radiotherapy dose \> 40 Gy

Exclusion Criteria:

* Failure to comply with any of the inclusion criteria

Primary outcomes:
measure: Acute toxicity
timeFrame: Highest during and within 2 weeks after last day of radiation therapy
measure: Late toxicity
timeFrame: Highest within one year after last day of radiation therapy
Secondary outcomes:
measure: Overall survival
timeFrame: at 1 year after first day of radiation therapy
measure: Overall survival
timeFrame: at 2 years after first day of radiation therapy
measure: Overall survival
timeFrame: at 3 years after first day of radiation therapy
measure: Overall survival
timeFrame: at 4 years after first day of radiation therapy
measure: Overall survival
timeFrame: at 5 years after first day of radiation therapy
measure: Loco-regional tumor control
timeFrame: at 1 year after first day of radiation therapy
measure: Loco-regional tumor control
timeFrame: at 2 years after first day of radiation therapy
measure: Loco-regional tumor control
timeFrame: at 3 years after first day of radiation therapy
Other outcomes:
measure: Patient-rated symptoms and Quality-of-Life
timeFrame: Within 1 week before or after last day of radiation therapy
measure: Patient-rated symptoms and Quality-of-Life
timeFrame: at 3 months after first day of radiation therapy
measure: Patient-rated symptoms and Quality-of-Life
timeFrame: at 6 months after first day of radiation therapy
measure: Patient-rated symptoms and Quality-of-Life
timeFrame: at one year after first day of radiation therapy
measure: Patient-rated symptoms and Quality-of-Life
timeFrame: at 2 years after first day of radiation therapy
measure: Patient-rated symptoms and Quality-of-Life
timeFrame: at 3 years after first day of radiation therapy
measure: Patient-rated symptoms and Quality-of-Life
timeFrame: at 4 years after first day of radiation therapy
measure: Patient-rated symptoms and Quality-of-Life
timeFrame: at 5 years after first day of radiation therapy
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Robin Wijsman, MD
role: PRINCIPAL_INVESTIGATOR
References: