A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy

NCT01351116 | Completed Phase 3 DMC

• 1 other identifier: OCOG-2011-BRACHY
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 8

Brief Summary

A trial to improve the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation.

Conditions

Non-small Cell Lung Cancer

Keywords

brachytherapy; external beam radiation; high dose rate intraluminal brachytherapy; lung cancer; quality of life; radiation treatment; bronchus

Outcome Measures

Primary Outcomes (1)

• For each subject, a lung cancer-related symptomatic improvement at 6 weeks post randomization, defined as a 10-point improvement on a 100 point scale from the summary question of lung cancer symptoms

  6 weeks from randomization

Secondary Outcomes (5)

• Improvement in each lung cancer symptom as measured by the Lung Cancer Symptom Scale (LCSS) as defined by a 10-point improvement for cough, shortness of breath, hemoptysis and pain on the LCSS at 6 weeks post randomization

  6 weeks post randomization

• Improvement in each lung cancer symptom and overall symptoms at any time after randomization

  at 3, 6, 12, 18, 26, 34, 42 and 50 weeks post-randomization

• A Quality of Life (QOL) improvement as measured be overall score of the LCSS, at each scheduled assessment point following randomization (Weeks 3, 6, 12, 26, 34, 42 and 50)

  Weeks 3, 6, 12, 18, 26, 34, 42 and 50

• Symptomatic progression-free survival (SPFS), defined as the time from randomization until death, use of chemotherapy, or the first post-randomization score on LCSS #7 which is 10 points or greater than the baseline score, or scored at 100.

  From date of randomization until the date of first documented use of chemotherapy, or progression whichever came first, assessed up to 48 months

• Overall survival, calculated from the date of randomization to the date of death

  From date of randomization until the date of death from any cause assessed up to 48 months

Study Arms (2)

EBR plus HDRIB

EXPERIMENTAL

External Beam Radiation (EBR) plus High Dose Rate Intraluminal Brachytherapy (HDRIB)

Radiation: EBR plus HDRIB

EBR

ACTIVE COMPARATOR

External Beam Radiation (EBR)

Radiation: EBR

Interventions

EBR plus HDRIB RADIATION

EBR of 20 Gy in 5 daily fractions over one week plus HDRIB of 14 Gy in 2 fractions over two weeks

EBR plus HDRIB

EBR RADIATION

EBR of 20 Gy in 5 daily fractions over one week

EBR

Eligibility Criteria

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

You may qualify if:

• Cytologic or histologic proof of non-small cell lung cancer (NSCLC)
• Stages III, IV or recurrent disease
• Documented endobronchial luminal disease by either endoscopy or CT-imaging
• Candidate for palliative thoracic radiation therapy because of cough, shortness of breath or hemoptysis

You may not qualify if:

• Age less than 18 years of age
• Uncontrolled or symptomatic brain metastases
• Anticipated survival of less than 3 months
• Systemic therapy planned to begin within 6 weeks following randomization
• Systemic therapy within 4 weeks of planned study randomization
• Any prior radiotherapy involving the lungs
• Cardiac arrest or myocardial infarction within 6 months prior to study randomization
• Inability to receive sedation or undergo invasive procedures due to severe chronic obstructive pulmonary disease (COPD), bleeding disorders, or other medical conditions which will preclude the use of HDRIB
• Pregnancy, lactation, or failure to use dual-method contraception in pre-menopausal women
• Unwillingness or inability (e.g. incompetence, severe psychiatric disorders) to complete informed consent and the baseline QoL assessments required for the trial
• Having received an investigational agent within one month of study randomization
• Inability to attend regular follow-up evaluations due to psychiatric or addictive disorder or geographic inaccessibility

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Canadian Cancer Society (CCS): collaborator

Study Sites (8)

Abbotsford Centre - BC Cancer Agency

Abbotsford, British Columbia, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2K 2R2, Canada

Location

London Regional Cancer Centre

London, Ontario, Canada

Location

UHN-Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Windsor Regional Hospital Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

CHUQ - L'Hôtel-Dieu de Québec

Québec, Quebec, G1R 2J6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ranjan Sur

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: May 10, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

CA (8)