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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068850 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-2012-02401 | Registry Identifier | CTRP (Clinical Trials Reporting System) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of 3-dimensional conformal radiotherapy.
Cohorts of 7-9 patients receive de-escalating doses of 3-dimensional conformal radiotherapy until the maximum tolerated dose (MTD) is determined when given in combination with chemotherapy. The MTD is defined as the highest dose at which no more than 1 patient experiences dose-limiting toxicity.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3-5 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 73 patients (up to 27 for phase I [closed to accrual as of 10/28/04] and 46 for phase II) will be accrued for this study within 1-1.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: 75.25 Gy/36 fx + chemotherapy | Experimental | Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. |
|
| Phase I: 74 Gy/37 fx + chemotherapy | Experimental | Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. |
|
| Phase I: 70 Gy/35 fx + chemotherapy | Experimental | Phase I: Three-dimensional conformal radiation therapy (3DRT) of 70 Gy given in 35 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. |
|
| Phase II: 74 Gy/37 fx + chemotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy | Dose limiting toxicity (DLT) = Grade 3/4 non-hematologic toxicities (excluding nausea, vomiting, and alopecia) and Grade 4 hematologic toxicities. The DLT rate for this study was set at 40% based on Radiation Therapy Oncology Group (RTOG) study 94-10. No acute (within 90 days from start of 3DRT) DLT's in the first 5 patients (0/5) or the combination of one acute DLT in the first 5 patients (1/5) and none in the next 2 patients (0/2) was required to deem a given dose level to be acceptable. If at any time a Grade 5 toxicity (death) occurred, accrual would be suspended and the event reviewed by a study chair. At any given dose level, this design gives at least 90% confidence that the true acute DLT rate is less than 40% and the probability of not escalating when the true toxicity rate is 40% or higher is at least 83%. Rating scale: 0 = not the MTD, 1 = MTD | From start of treatment to 90 days |
| Percentage of Patients Who Survive at Least 12 Months | Null hypothesis: p<= 62.3% (the best arm of RTOG 94-10); alternative hypothesis: p>= 77.9%. Where p is the percentage of patients alive at at 12 months. Using a one-group chi-square test with alpha = 0.10, a sample size of 50 patients provides at least 87% power to detect a 25% or greater relative increase in the 12-month survival rate, or equivalently, an absolute increase of at least 15.6 percentage points (62.3 versus 77.9). If the point estimate is greater than 71.1% (upper bound), then the conclusion is that the 12-month survival rate from the new treatment significantly improved from 62.3%. | From registration to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Highest Grade Chemotherapy/Acute RT Toxicities and Late RT Toxicities. | Highest grade toxicity per subject was counted. Toxicities were graded using the Common Toxicity Criteria (CTC) v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.Chemotherapy/Acute RT toxicities occur during chemotherapy and/or within 90 days of the start of RT. Late RT toxicities occur more than 90 days after the start of RT. |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed unresectable stage IIIB non-small cell lung cancer
All detectable primary tumor and involved regional lymph nodes must be encompassed by radiotherapy fields
Measurable disease on 3-dimensional planning CT scan
No undifferentiated small cell (oat cell or high-grade neuroendocrine) carcinoma
No stage IV or recurrent disease
No distant metastases or supraclavicular lymph node involvement
No significant atelectasis (i.e., atelectasis of an entire lung)
No pleural effusions, pericardial effusions, or superior vena cava syndrome
No lung cancer within the past 2 years
Ineligible for currently open Radiation Therapy Oncology Group (RTOG) phase III lung protocols
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Bradley, MD | Mallinckrodt Institute of Radiology at Washington University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36652-2144 | United States | ||
| Arizona Oncology Services Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20368547 | Result | Bradley JD, Bae K, Graham MV, Byhardt R, Govindan R, Fowler J, Purdy JA, Michalski JM, Gore E, Choy H. Primary analysis of the phase II component of a phase I/II dose intensification study using three-dimensional conformal radiation therapy and concurrent chemotherapy for patients with inoperable non-small-cell lung cancer: RTOG 0117. J Clin Oncol. 2010 May 10;28(14):2475-80. doi: 10.1200/JCO.2009.27.1205. Epub 2010 Apr 5. | |
| 20457350 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: 75.25 Gy/36 fx + Chemotherapy | Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. |
|
| paclitaxel | Drug |
|
| three-dimensional conformal radiation therapy | Radiation |
|
| Chemotherapy/Acute RT toxicity: from start of treatment to 90 days from start of study treatment; Late RT toxicity: from 90 days after start of treatment to last follow-up (Maximum follow-up = 57.9 months.) |
| Partial Organ Tolerance Doses for Lung and Esophagus (Percent Volume of Total Lung Receiving > 20 Gy by Toxicity Level) | Percent volume of total lung receiving > 20 Gy radiation therapy (Lung V20) was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, it was also compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. | From start of treatment to last follow-up (Maximum follow-up = 57.9 months.) |
| Partial Organ Tolerance Doses for Lung and Esophagus (Mean Organ Dose by Toxicity Level) | Mean lung dose was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, mean lung dose, and mean esophageal dose were compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. | From start of treatment to last follow-up (Maximum follow-up = 57.9 months.) |
| Number of Patients With Complete Response at 3 Months After Completion of Therapy | "Complete response" means no evidence of tumor on the CT scan. | From start of treatment until 3 months after completion of all study treatment, estimated to be 5 or 6.5 months depending whether or not subject received optional adjuvant chemotherapy. |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Providence Saint Joseph Medical Center - Burbank | Burbank | California | 91505 | United States |
| Providence Holy Cross Cancer Center | Mission Hills | California | 91346-9600 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| Bay Medical | Panama City | Florida | 32401 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Saint Anthony's Hospital at Saint Anthony's Health Center | Alton | Illinois | 62002 | United States |
| Alexian Brothers Radiation Oncology | Elk Grove Village | Illinois | 60007 | United States |
| Good Samaritan Regional Health Center | Mount Vernon | Illinois | 62864 | United States |
| Oncology Center at Saint Margaret Mercy Healthcare Center | Hammond | Indiana | 46320 | United States |
| Cancer Center at Ball Memorial Hospital | Muncie | Indiana | 47303-3499 | United States |
| Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi | 39581 | United States |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Cape Girardeau | Missouri | 63701 | United States |
| Cancer Institute of Cape Girardeau, LLC | Cape Girardeau | Missouri | 63703 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65802 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| CCOP - St. Louis-Cape Girardeau | St Louis | Missouri | 63141 | United States |
| David C. Pratt Cancer Center at St. John's Mercy | St Louis | Missouri | 63141 | United States |
| Ocean Medical Center at Meridian Health | Brick | New Jersey | 08724 | United States |
| J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River | New Jersey | 08755 | United States |
| Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland | New Jersey | 08360 | United States |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | 13057 | United States |
| High Point Regional Hospital | High Point | North Carolina | 27261 | United States |
| Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| Three Rivers Community Hospital | Grants Pass | Oregon | 97527 | United States |
| Dubs Cancer Center at Rogue Valley Medical Center | Medford | Oregon | 97504 | United States |
| Providence Cancer Center at PMCC | Medford | Oregon | 97504 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0361 | United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410-1894 | United States |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling | West Virginia | 26003 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee | Wisconsin | 53295 | United States |
| Tom Baker Cancer Centre - Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| Result |
| Bradley JD, Moughan J, Graham MV, Byhardt R, Govindan R, Fowler J, Purdy JA, Michalski JM, Gore E, Choy H. A phase I/II radiation dose escalation study with concurrent chemotherapy for patients with inoperable stages I to III non-small-cell lung cancer: phase I results of RTOG 0117. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):367-72. doi: 10.1016/j.ijrobp.2009.04.029. |
| Result | Bradley JD, Graham M, Suzanne S, et al.: Phase I results of RTOG L-0117: a phase I/II dose intensification study using 3DCRT and concurrent chemotherapy for patients with inoperable NSCLC. [Abstract] J Clin Oncol 23 (Suppl 16): A-7063, 636s, 2005. |
| FG001 | Phase I: 74 Gy/37 fx + Chemotherapy | Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. |
| FG002 | Phase I: 70 Gy/35 fx + Chemotherapy | Phase I: Three-dimensional conformal radiation therapy (3DRT) of 70 Gy given in 35 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. |
| FG003 | Phase II: 74 Gy/37 fx + Chemotherapy | Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Eligible patients who started protocol treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: 75.25 Gy/36 fx + Chemotherapy | Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. |
| BG001 | Phase I: 74 Gy/37 fx + Chemotherapy | Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. |
| BG002 | Phase II: 74 Gy/37 fx + Chemotherapy | Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy | Dose limiting toxicity (DLT) = Grade 3/4 non-hematologic toxicities (excluding nausea, vomiting, and alopecia) and Grade 4 hematologic toxicities. The DLT rate for this study was set at 40% based on Radiation Therapy Oncology Group (RTOG) study 94-10. No acute (within 90 days from start of 3DRT) DLT's in the first 5 patients (0/5) or the combination of one acute DLT in the first 5 patients (1/5) and none in the next 2 patients (0/2) was required to deem a given dose level to be acceptable. If at any time a Grade 5 toxicity (death) occurred, accrual would be suspended and the event reviewed by a study chair. At any given dose level, this design gives at least 90% confidence that the true acute DLT rate is less than 40% and the probability of not escalating when the true toxicity rate is 40% or higher is at least 83%. Rating scale: 0 = not the MTD, 1 = MTD | The first seven eligible patients who started protocol treatment at each dose level. | Posted | Number | units on a scale | From start of treatment to 90 days |
|
|
| |||||||||||||||||||||||||||||
| Primary | Percentage of Patients Who Survive at Least 12 Months | Null hypothesis: p<= 62.3% (the best arm of RTOG 94-10); alternative hypothesis: p>= 77.9%. Where p is the percentage of patients alive at at 12 months. Using a one-group chi-square test with alpha = 0.10, a sample size of 50 patients provides at least 87% power to detect a 25% or greater relative increase in the 12-month survival rate, or equivalently, an absolute increase of at least 15.6 percentage points (62.3 versus 77.9). If the point estimate is greater than 71.1% (upper bound), then the conclusion is that the 12-month survival rate from the new treatment significantly improved from 62.3%. | Eligible patients at the MTD dose level who started protocol treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to 1 year |
|
| |||||||||||||||||||||||||||||
| Secondary | Frequency of Highest Grade Chemotherapy/Acute RT Toxicities and Late RT Toxicities. | Highest grade toxicity per subject was counted. Toxicities were graded using the Common Toxicity Criteria (CTC) v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.Chemotherapy/Acute RT toxicities occur during chemotherapy and/or within 90 days of the start of RT. Late RT toxicities occur more than 90 days after the start of RT. | Eligible patients from Phase I and II 74 Gy arms who started study treatment. Additionally for late RT toxicity, those who have toxicity data at least 90 days from start of RT. | Posted | Count of Participants | Participants | Chemotherapy/Acute RT toxicity: from start of treatment to 90 days from start of study treatment; Late RT toxicity: from 90 days after start of treatment to last follow-up (Maximum follow-up = 57.9 months.) |
| |||||||||||||||||||||||||||||||
| Secondary | Partial Organ Tolerance Doses for Lung and Esophagus (Percent Volume of Total Lung Receiving > 20 Gy by Toxicity Level) | Percent volume of total lung receiving > 20 Gy radiation therapy (Lung V20) was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, it was also compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. | All eligible patients on the phase I and II 74 Gy arms who received treatment and had RT plan data available with the given structure | Posted | Median | Full Range | Percent (V20) | From start of treatment to last follow-up (Maximum follow-up = 57.9 months.) |
| ||||||||||||||||||||||||||||||
| Secondary | Partial Organ Tolerance Doses for Lung and Esophagus (Mean Organ Dose by Toxicity Level) | Mean lung dose was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, mean lung dose, and mean esophageal dose were compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. | All eligible patients on the phase I and II 74 Gy arms who received treatment and had RT plan data available with the given structure | Posted | Mean | Full Range | Gy (mean dose) | From start of treatment to last follow-up (Maximum follow-up = 57.9 months.) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Complete Response at 3 Months After Completion of Therapy | "Complete response" means no evidence of tumor on the CT scan. | Eligible patients from Phase I and II 74 Gy arms who started study treatment. | Posted | Count of Participants | Participants | From start of treatment until 3 months after completion of all study treatment, estimated to be 5 or 6.5 months depending whether or not subject received optional adjuvant chemotherapy. |
|
|
Not provided
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I: 75.25 Gy/36 fx + Chemotherapy | Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. | 7 | 8 | 8 | 8 | ||
| EG001 | Phase I/II: 74 Gy/37 fx + Chemotherapy | Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional. | 36 | 53 | 52 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemolysis NOS | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Packed red blood cell transfusion | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Platelet transfusion | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Arrhythmia NOS | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Supraventricular arrhythmia NOS | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Esophageal spasm | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Esophagitis NOS | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Esophagus | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Heart | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Lung | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Other | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypersensitivity NOS | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection NOS | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection with grade 3 or 4 neutropenia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Other | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTCAE (2.0) | Non-systematic Assessment |
| |
| Operative injury of vein/artery | Injury, poisoning and procedural complications | CTCAE (2.0) | Non-systematic Assessment |
| |
| Cardiac troponin I increased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyperglycemia NOS | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Muscle weakness NOS | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Convulsions NOS | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Renal failure NOS | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Renal/GU-Other | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dyspnea NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pneumonitis NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pulmonary-other | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypotension NOS | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Peripheral ischaemia NOS | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Thrombosis NOS | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematologic-Other | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Supraventricular arrhythmia NOS | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hearing-Other | Ear and labyrinth disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Abdominal pain NOS | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Esophageal spasm | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Esophagitis NOS | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Gastritis NOS | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Radiation mucositis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rectal bleeding | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Edema NOS | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bone | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Esophagus | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Heart | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Lung | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Other | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Skin (within the irradiated field) | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Spinal cord | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Subcutaneous tissue | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Pain due to radiation | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rigors | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hepatic-Other | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypersensitivity NOS | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection NOS | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTCAE (2.0) | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase NOS increased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Forced expiratory volume decreased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Metabolic-Other | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Blood albumin decreased | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Blood magnesium decreased | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyperglycemia NOS | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypoglycaemia NOS | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Joint, muscle, or bone-Other | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Amnesia NEC | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ataxia NEC | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Convulsions NOS | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dizziness (exc vertigo) | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Headache NOS | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neuralgia NOS | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neurologic-Other | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Speech disorder NEC | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Taste disturbance | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Tremor NEC | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Anxiety NEC | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Depression NEC | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Insomnia NEC | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Renal failure NOS | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Renal/GU-Other | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dyspnea NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pneumonitis NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pneumothorax NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pulmonary-other | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dermatitis exfoliative NOS | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nail abnormality NOS | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Skin discoloration | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Skin-Other | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypertension NOS | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypotension NOS | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
|
This study was originally designed to escalate 3DRT via increasing doses per fraction. However, due to excessive toxicity at dose level 1 (75.25 Gy, 2.15 Gy/fraction), the protocol was amended in January 2003 to de-escalate 3DRT dose.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | Radiation Therapy Oncology Group | wseiferheld@acr.org |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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