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NCT Number: NCT02752126

A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus

A randomized phase II study of palliative radiation of advanced central lung tumors with intentional avoidance of the esophagus. Patients will be randomized between standard of care palliative thoracic radiation and esophageal-sparing intensity-modulated radiation therapy (ES-IMRT) in a 1:1 ratio. Radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 1 year after completion of their radiation therapy. The primary endpoint is esophageal quality of life as measured by the Esophageal Cancer Subscore (ECS) of the Functional Assessment of Cancer Therapy-Esophagus (FACT-E).

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cross Cancer Institute, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Joint Committee on Cancer (AJCC) 7th edition stage IV NSCLC or stage III not eligible for curative intent treatment
  • Intended to receive palliative radiotherapy to the thorax, to a dose of 30Gy in 10 fractions or 20Gy in 5 fractions. In either treatment arm at least 5cm of the esophagus should be in the intended treatment field.
  • Willingness and ability to provide informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-3
  • Age 18 years or older
  • Prior or planned systemic therapy (chemotherapy, immunotherapy, targeted agents) is permissible at the discretion of the treating medical oncologist, provided that no systemic treatment is given within 2 weeks prior to RT, concurrent with RT or within a 2-week period post RT.
  • Concurrent palliative RT to other metastatic sites is permissible
  • Life expectancy > 3 months

Exclusion criteria

  • Prior thoracic RT
  • Serious medical comorbidities precluding RT
  • Pregnant or lactating women
  • Inability to attend the full course of RT or planned follow-up visits
  • Planned concurrent palliative RT to the stomach and/or liver
  • Congenital abnormalities of the esophagus or severe disorders of the esophagus (e.g. achalasia)

Treatment and study plan

Conventional radiotherapy

Radiation

Patients will receive standard palliative radiation in dose of 30Gy in 10 fractions, or 20Gy in 5 fractions.

Esophageal-Sparing Intensity-Modulated Radiotherapy

Radiation

Patients will receive esophageal-sparing intensity-modulated radiotherapy, of 30Gy in 10 fractions or 20Gy in 5 fractions.

Primary outcomes

  1. Esophageal Quality of Life

    Time frame: 2 weeks after completion of radiotherapy

    Esophageal quality of life will be measured by the ECS of the FACT-E, measured at 2 weeks.

Secondary outcomes

  1. Survival

    Time frame: 6 months after completion of radiotherapy

    Survival

  2. Toxicity Rate Differences

    Time frame: 6 months after completion of radiotherapy

    Differences in rates of grade 2 or higher toxicity between groups will be tested using the Fisher's Exact test.

  3. Progression-Free Survival

    Time frame: 6 months after completion of radiotherapy

    Differences in local/regional progression-free survival will be tested using the stratified log-rank test

  4. Further Systemic Therapy

    Time frame: 6 months after completion of radiotherapy

    Differences in number of cycles of further systemic therapy will be tested using the student's t-test

  5. Cost-Effectiveness/Utility Analysis

    Time frame: 6 months after completion of radiotherapy

    European Quality of Life-5 Dimensions (EQ-5D) measurements will be converted into utilities to inform cost-effectiveness/utility analysis.

  6. Dosimetry Comparison - Gross Tumor Volume (GTV)

    Time frame: 6 months after completion of radiotherapy

    Dosimetric comparison of GTV will be compared using the student's t-test.

  7. Dosimetry Comparison - Planning Target Volume (PTV)

    Time frame: 6 months after completion of radiotherapy

    Dosimetric comparison of PTV will be compared using the student's t-test.

  8. Dosimetry Comparison - Pulmonary Metrics

    Time frame: 6 months after completion of radiotherapy

    Dosimetric comparison of standard pulmonary metrics will be compared using the student's t-test.

  9. Dosimetry Comparison - Esophageal Metrics

    Time frame: 6 months after completion of radiotherapy

    Dosimetric comparison of standard esophageal metrics will be compared using the student's t-test.

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Acronym: PROACTIVE

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 26, 2016
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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