Radical Resection Vs. Ablative Stereotactic Radiotherapy in Patients With Operable Stage I NSCLC (POSTILV)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Varian Medical Systems
NRG Oncology Foundation, Inc.
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01753414
First received: December 17, 2012
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

Rationale: Surgery remains the standard of care for stage 1 (T1-2a N0)non-small cell lung cancer. Stereotactic body radiation therapy is a newer radiation treatment that gives fewer but higher and possibly more effective doses of radiation than standard radiation. This technique may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known whether stereotactic body radiation therapy is more effective than surgery in treating non-small cell lung cancer.

Purpose: The primary aim of this randomized phase II trial is to determine if the efficacy of SBRT is comparable to that of standard surgical interventions for patients with T1N0 non-small cell lung cancer.


Condition Intervention Phase
Non-small Cell Lung Cancer
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Procedure: Surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: POSTILV: A RANDOMIZED PHASE II TRIAL IN PATIENTS WITH OPERABLE STAGE I NON-SMALL CELL LUNG CANCER: RADICAL RESECTION VERSUS ABLATIVE STEREOTACTIC RADIOTHERAPY - This is a Limited Participation Study.

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Local-regional control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The time from randomization until local or regional progression.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time from randomization until death

  • Disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time from randomization until progression or death, whichever occurs first

  • Frequency of site-specific failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Local-regional tumor failure; distant metastases; second primary

  • Time to local-regional tumor failure and distant metastases [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time from randomization until local or regional progression, or distant metastases

  • PET tumor response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessment of failure patterns after treatment and PET data

  • Frequency of adverse events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Distributions of specific adverse events of interest

  • Trial feasibility parameters [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Descriptive statistics relating to rates of credentialing, eligibility, and timely submission of baseline and follow-up forms


Estimated Enrollment: 76
Study Start Date: December 2012
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Surgery
Complete resection, i.e., removal of the primary tumor with at least a 2 cm margin together with nodal dissection/sampling
Procedure: Surgery
Complete resection, i.e., removal of the primary tumor with at least a 2 cm margin together with nodal dissection/sampling
Other Name: R0 resection with nodal dissection/sampling (RODS)
Experimental: Sterotactic Body Radiation Therapy (SBRT)
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days
Radiation: Stereotactic Body Radiation Therapy (SBRT)
SBRT given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days
Other Name: Stereotactic Body Radiation Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Pathologically (histologically or cytologically) proven diagnosis of Stage I NSCLC (AJCC, 7th ed.), T1N0M0; note: T1N0 disease must be confirmed by FDG-PET/CT

The following primary cancer types are eligible: squamous cell carcinoma; adenocarcinoma; large cell carcinoma/ large cell neuroendocrine carcinoma; non-small cell carcinoma not otherwise specified.

  • Patients with hilar or mediastinal lymph nodes ≤ 1 cm and no abnormal hilar or mediastinal uptake on PET and CT will be considered N0. Mediastinal lymph node biopsy is required for patients with visible nodes: patients with > 1 cm hilar or mediastinal lymph nodes on CT or with nodes appearing as abnormal on PET (including suspicious but nondiagnostic uptake). Such patients will not be eligible unless directed biopsies of all abnormal lymph nodes are negative for cancer or these nodes demonstrate a lack of change during the prior 6 months and thus are considered to be non-malignant.
  • The patient must be considered a reasonable candidate for surgical resection using a lobectomy or pneumonectomy of the primary tumor within 6 weeks prior to registration, according to the following criteria based on the American College of Chest Physicians guidelines [165]:

    • A qualified thoracic surgeon should make the determination that there would be a high likelihood of negative surgical margins;
    • Baseline FEV1 >60% predicted, postoperative predicted FEV1 >40% predicted;
    • Diffusion capacity of the lung for carbon monoxide (DLCO) >60% predicted, postoperative predicted DLCO > 40 % predicted;
    • No baseline hypoxemia and/or hypercapnia;
    • If the estimated postoperative FEV1 or DLCO <40% predicted indicates an increased risk for perioperative complications, including death, from a standard lung cancer resection (lobectomy or greater removal of lung tissue), then cardiopulmonary exercise testing to measure maximal oxygen consumption (VO2max) must be >60%;
    • No severe pulmonary hypertension;
    • No severe cerebral, acute or chronic cardiac, or peripheral vascular disease;
  • Pleural effusion, if present, must be deemed too small to tap under CT guidance and must not be evident on chest x-ray. Pleural effusion that appears on chest x-ray will be permitted only if there is no evidence of malignancy after invasive cytologic assessment.
  • Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:

    • History/physical examination, including documentation of weight within 6 weeks prior to registration;;
    • Evaluation by an experienced thoracic surgeon within 6 weeks prior to registration;
    • FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration;
    • CT scan (preferably with intravenous contrast, unless medically contraindicated) within 4 weeks prior to registration to include the entirety of both lungs, the mediastinum, liver, and adrenal glands; primary tumor dimension will be measured on CT scan.
  • Zubrod Performance Status 0-1 within 6 weeks prior to registration;
  • Age ≥ 18;
  • For women of childbearing potential, a serum or urine pregnancy test must be negative within 72 hours prior to registration;
  • Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment if assigned to treatment with SBRT.
  • Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

  • Direct evidence of regional or distant metastases after PET and surgical staging studies, or synchronous primary malignancy or prior invasive malignancy in the past 3 years, with the following exceptions:

    • carcinoma in situ;
    • early stage skin cancer that has been definitively treated;
    • when an invasive malignancy has been treated definitively and the patient has remained disease free for ≥ 3 years;
  • Primary tumors >3 cm;
  • Prior systemic chemotherapy or thoracic surgery involving lobectomy or pneumonectomy;
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
  • Pure bronchioloalveolar carcinoma subtype of non-small cell lung cancer;
  • Active systemic, pulmonary, or pleural pericardial infection;
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753414

Locations
China
Chinese Academy of Medical Science
Beijing, China, 10021
Beijing Cancer Hospital
Beijing, China
Shandong Cancer Hospital, Jinan
Shangdong, China, 250117
Shanghai Cancer Center/Fudan University
Shanghai, China, 200032
Zhejiang Cancer Hospital, Hangzhou
Zhejiang, China, 310022
Sponsors and Collaborators
Radiation Therapy Oncology Group
Varian Medical Systems
NRG Oncology Foundation, Inc.
Investigators
Principal Investigator: Feng-Ming (Spring) Kong, MD, PhD Medical College of Georgia/Georgia Regents University Cancer Center
  More Information

No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01753414     History of Changes
Other Study ID Numbers: RF-3502
Study First Received: December 17, 2012
Last Updated: July 23, 2014
Health Authority: China: Ministry of Health

Keywords provided by Radiation Therapy Oncology Group:
Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014