Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable NSCLC

NCT00692380 | Terminated Phase 1 DMC

• 1 other identifier: MCC-10274
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Radiation therapy technology that allows increased radiation dose to the tumor while sparing healthy tissue will improve the balance between complications and cure.

Conditions

Non-small Cell Lung Cancer

Keywords

gated IMRT

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  3 years

Secondary Outcomes (1)

• To identify partial organ tolerance doses for lung and esophagus when treating with involved field thoracic 3D. To estimate complete response rate as defined by PET performed 3 months after completion of all therapy.

  3 years

Study Arms (1)

A

EXPERIMENTAL

Fractionated Radiation Therapy followed by Carboplatin and Taxol

Radiation: Fractionated radiation therapy followed by chemotherapy

Interventions

Fractionated radiation therapy followed by chemotherapy RADIATION

Increasing doses of radiation therapy

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically-proven, by biopsy or cytology, unresectable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma, not otherwise specified.
• Patient with AJCC Stage IIIA-IIIB, if all detectable tumor can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes.
• fluoro-2-deoxyglucose positron emission tomography required for staging and image fusion for treatment planning.
• Atelectasis, if present, must be less than one lung.
• Patients must have granulocytes \>1500/µl; platelets \>100,000/µl; bilirubin \< 1.5 mg/dl; AST(SGOT) \< 2 ULN; serum creatinine \< 2.0 mg/dl.
• Zubrod Score 0-1.
• FEV1 must be \>1.0 L.
• Patients must sign a study-specific informed consent form prior to study entry
• Patients must have measurable disease on the planning CT.
• Patient must have a completed the IMRT plan and the attending physician must have reviewed and approved the dose volume histograms as follows (based on treatment planning to the Phase 4 dose level): total lung V20 \< 30%, mean esophageal dose \< 34 Gy, the esophageal V55 \< 30%, the heart V40 \< 50%.
• No prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for one year or more; no prior lung cancer within last two years.
• No prior RT to thorax.
• No previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past five (5) years.
• No distant metastases or supraclavicular lymph node involvement or significant atelectasis.
• No clinically significant pleural effusions, pericardial effusions or superior vena cava syndrome.

You may not qualify if:

• Undifferentiated small cell (oat cell or high grade neuroendocrine) carcinoma, any stage.
• Stage I, II or IV NSCLC.
• Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
• Concurrent malignancy except non-melanomatous skin cancer or prior cancer unless disease-free for one year or more.
• Prior radiation therapy to the thorax.
• Previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past five (5) years.
• Distant metastases or supraclavicular lymph node involvement, or atelectasis of an entire lung.
• Patients who have not had the pre-treatment evaluations in Section 4.0 or evaluations performed \> 8 weeks prior to study entry.
• Patients with clinically significant pleural effusions, pericardial effusions or superior vena cava syndrome.
• Prior lung cancer within the last two years.
• Patients who have significant atelectasis and in whom the CT definition of the gross tumor volume(GTV) is difficult to determine.
• Pregnant or lactating females. It is not known what effects this treatment may have on the developing fetus.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Massey Cancer Center

Richmond, Virginia, 23219, United States

Location

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

• Elisabeth Weiss, M.D.

  Massey Cancer Center

  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: June 3, 2008
• First Posted: June 6, 2008
• Study Start: June 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 2, 2016

Record last verified: 2016-04

Locations

US (1)