An International Study on the Use of PET/CT in Radiotherapy Planning in Low and Middle Income Countries

NCT02247713 | Unknown

• 1 other identifier: M14PRI
• Study Type: observational
• Target: 520
• Locations: 0 countries
• Sites: N/A

Brief Summary

A part retrospective, part prospective cohort study to assess the difference in 2-year overall survival in patients with stage III NSCLC receiving chemoradiotherapy with curative intent in low and middle income countries before and after a training intervention on the use of PET/CT for radiotherapy treatment planning.

Conditions

Non Small Cell Lung Cancer Stage III

Keywords

PET; radiotherapy; international; NSCLC; overall survival; low and middle income countries

Outcome Measures

Primary Outcomes (1)

• 2-year overall survival

  Determine the impact of PET/CT in RTP on 2-year overall survival rates for patients with stage III NSCLC receiving chemoradiotherapy with curative intent. Patients from the retrospective cohort will be selected from the institutional database and were treated between 2010 to 2013. Patients from the prospective cohort will be selected until the end of 2015.

  the included patients will be followed for a maximum of 2 years

Secondary Outcomes (2)

• Observer agreement with expert contours as a measure of the effect of a training intervention on tumor volume delineation

  up to 5 months

• Baseline PET/CT characteristics as a measure for PET/CT scanner performance

  up to 8 months

Study Arms (2)

Retrospective cohort

Participating centers will retrospectively provide demographic, tumor, treatment and follow-up details on at least 25 consecutive patients with stage III NSCLC previously treated with curative intent chemoradiotherapy (concurrent or sequential) in the period between 2010 and 2013.

Prospective cohort

Participating centers will provide prospective data on patients with stage III NSCLC treated with curative intent concurrent chemoradiotherapy. Centers will be asked to include at least 25 consecutive cases following the training intervention and the successful local implementation of PET/CT for RTP in NSCLC.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The retrospective cohort study includes at least 250 patientswith stage III NSCLC with curative intent chemoradiotherapy (sequential or concurrent), 125 patients in the first arm (non PET staged) and 125 patients (PET staged) in the second arm. The prospective cohort study includes at least 250 patients (PET staged) receiving concurrent chemoradiotherapy based on PET/CT RTP. In total, we aim to include a number of 519 patients.

You may qualify if:

• pathologically confirmed NSCLC
• stage III as per local diagnostic protocol or agreement of local multidisciplinary team
• available for clinical follow-up for at least 2 years
• suitable for treatment with a radical target volume in the opinion of a radiation oncologist
• ECOG performance 0 or 1
• signed informed consent
• ability to commence radiation therapy within 4 weeks of acquisition of the RTP PET/CT
• suitable for concurrent chemoradiotherapy (prospective cohort only)

You may not qualify if:

• other neoplasms in the last 5 years except non-melanoma skin cancer
• stage IV disease diagnosed before acquisition of staging PET/CT
• inability to provide informed consent
• uncontrolled diabetes mellitus
• pregnant or breast feeding mothers
• tuberculosis
• neo-adjuvant chemotherapy

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• International Atomic Energy Agency: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wouter V Vogel, MD

  Antoni van Leeuwenhoek - Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

• Gerard G Hanna, MD

  Centre for Cancer Research and Cell Biology, Queen's University Belfast

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Konert, BSc

CONTACT

0031205127954; t.konert@nki.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: September 25, 2014

Record last verified: 2014-09