Clinical trial NCT00692380: Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable NSCLC
Official title: A Phase I Dose Intensification Study Using Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Patients With Inoperable, Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Keywords: gated IMRT
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The primary objective is to establish the maximum tolerated fractional dose (MTfD) of radiotherapy to a total dose of 78Gy using gated IMRT, delivered in single daily fractions that can be administered concurrently with Taxol® and carboplatin chemotherapy. Secondary objectives include: to evaluate the toxicity of concurrent Taxol® and carboplatin with gated IMRT; identify partial organ tolerance doses for lung and esophagus when treating with involved field thoracic 3D; estimate complete response rate as defined by PET performed 3 months after completion of all therapy.

Eligibility criteria: Inclusion Criteria:

* 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.
* 18-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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: 3 years
Secondary outcomes:
measure: 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.
timeFrame: 3 years
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Massey Cancer Center
state: Virginia
Study officials:
affiliation: Massey Cancer Center
name: Elisabeth Weiss, M.D.
role: PRINCIPAL_INVESTIGATOR
References: