Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC

NCT02059967 | Withdrawn Phase 1 DMC

• 4 other identifiers: MCC-13-09209HM20000101MCC-20000101NCI-2014-00163
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase I trial studies the side effects and best dose of image-guided adaptive radiation therapy using active breathing control when given together with chemotherapy and simultaneous integrated boost in treating patients with stage IIA-IIIB non-small cell lung cancer that cannot be removed by surgery. Image-guided adaptive radiation therapy aims radiation therapy right at the tumor so that higher radiation doses can be given without causing bad side effects. Giving these higher doses may help control the tumor better. Breathing causes organs and tissues, including the tumor, to move within the chest. Active breathing control may reduce the volume that needs to be treated. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving image-guided adaptive radiation therapy using active breathing control with chemotherapy and simultaneous integrated boost may be an effective treatment for non-small cell lung cancer.

Conditions

Adenocarcinoma of the Lung; Large Cell Lung Cancer; Squamous Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IIB Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer

Keywords

Lung

Outcome Measures

Primary Outcomes (1)

• MTD, defined as the highest dose level at which =< 3 out of 7 patients experience a dose-limiting toxicity

  (using daily image-guidance, deformable image registration, adaptive replanning at defined time points, and dose intensification at normal tissue tolerance) of radiotherapy delivered concomitantly with standard chemotherapy.

  3 months

Secondary Outcomes (4)

• Incidence of acute toxicity measured using the National Cancer Institution Common Terminology for Adverse Events version 4.0

  Up to 90 days from radiation therapy start

• Incidence of late toxicity measured using the Radiation Therapy Oncology Group Late Radiation Morbidity Scoring

  Up to 5 years

• Practicability of the approach

  Up to 5 years

• Tumor response evaluated according to Response Evaluation Criteria in Solid Tumors v1.1

  Up to 15 years

Study Arms (1)

Treatment (IGART using ABC, SIVAB, paclitaxel, carboplatin)

EXPERIMENTAL

Patients undergo IGART using ABC 5 days a week for 7 weeks, for a total of 33 fractions with SIVAB during fractions 26-33. Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.

Drug: Paclitaxel; Radiation: image-guided adaptive radiation therapy; Drug: carboplatin

Interventions

Paclitaxel DRUG

Given IV

Also known as: 5beta,20-epoxy-1,2alpha,4,7beta,10beta, 6,12b-bis(acetyloxy)-12-(benzoyloxy)-1a,33,4,-4, Anzatax, Asotax, Bristaxol, Praxel, TAX, Taxol, Taxol Konzentrat

Treatment (IGART using ABC, SIVAB, paclitaxel, carboplatin)

image-guided adaptive radiation therapy RADIATION

Undergo IGART

Also known as: IGART, image-guided adaptive radiotherapy

Treatment (IGART using ABC, SIVAB, paclitaxel, carboplatin)

carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA,, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, platinum, Ribocarbo

Treatment (IGART using ABC, SIVAB, paclitaxel, carboplatin)

Eligibility Criteria

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

You may qualify if:

• Histologically-proven (by biopsy or cytology), unresectable or inoperable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma not otherwise specified.
• The tumor stage must be Stage IIA-IIIB (AJCC 7th edition). See http://aboutcancer.com/AJCC 7th lung 1.gif and http://aboutcancer.com/AJCC 7th lung 2.gif for staging.
• All detectable tumor must be encompassed by radiation therapy fields.
• fluorodeoxyglucose PET is required for staging and treatment planning.
• Atelectasis, if present, must involve less than a complete lung.
• Laboratory values:
• Neutrophils \>1500/µL
• Platelets \>100,000/µL
• Bilirubin \< 1.5 mg/dL
• Aspartate aminotransferase (AST; formerly serum glutamic oxaloacetic transaminase \[SGOT\]) \< 2x upper limit normal
• Alanine aminotransferase (ALT; formerly serum glutamic pyruvic transaminase \[SGPT\]) \< 2x upper limit normal
• Serum creatinine \< 2.0 mg/dL
• Glomerular filtration rate (GFR) calculated (kidney function test) within 30 days must be ≥ 59 mL/min
• Pulmonary function test (PFT) with FEV-1 ≥ 1.0 L/sec
• Plan of curative radiotherapy with or without concurrent chemotherapy.

You may not qualify if:

• Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
• Prior radiation therapy to the thorax.
• Previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past 5 years.
• Clinically significant pleural effusions, pericardial effusions, or superior vena cava syndrome.
• Oxygen supplementation required during therapy.
• Involvement of the brachial plexus, or infiltration of the aorta, heart, or esophagus.
• Tumors that affect more than one lobar bronchus, except the second involved bronchus in the right middle lobe bronchus.
• Unable to perform the BH procedures, unless tumor motion is ≤ 3 mm.
• Myocardial infarction within the last 6 months, symptomatic heart disease, uncompensated chronic obstructive pulmonary disease (COPD), or uncontrolled bronchospasms.
• History of a prior malignancy from which the patient has not been disease free for a minimum of 2 years, other than adequately treated basal/squamous skin cancer or in situ cervix cancer or other in situ malignancy.
• Pregnant or lactating women.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel; Taxes; Carboplatin; Platinum

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Coordination Complexes; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Elisabeth Weiss, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 19, 2015

Record last verified: 2015-03