Lung CancerPhase 1/2NCT00023673

Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer

A Phase 1/2 study testing carboplatin, paclitaxel and three-dimensional conformal radiation therapy in people with Lung Cancer, run by Radiation Therapy Oncology Group at 41 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Lung Cancer
What is being tested?: carboplatin, paclitaxel and three-dimensional conformal radiation therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 41 sitesin 2 countries
Study dates: Jul 2001to Nov 2013
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed unresectable stage IIIB non-small cell lung cancer
Squamous cell carcinoma
Adenocarcinoma
Large cell carcinoma
Non-small cell carcinoma not otherwise specified
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:

Not specified

Performance status:

Zubrod 0-1

Life expectancy:

Not specified

Hematopoietic:

Granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin less than 1.5 mg/dL
Aspartate aminotransferase (AST) less than 2 times upper limit of normal

Renal:

Creatinine no greater than 2.0 mg/dL

Pulmonary:

Forced expiratory volume (FEV)_1 at least 1.0 L

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No weight loss greater than 5% in the past 6 months
No other malignancy within the past year except nonmelanoma skin cancer
Completed 3D plan with total lung V20 </= 30% mean esophageal dose </= 34 Gy and esophageal V55 </= 30%

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior biologic response modifiers for current lung cancer
At least 5 years since prior biologic response modifiers

Chemotherapy:

No prior chemotherapy for current lung cancer
At least 5 years since prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
No prior radiotherapy to the thorax

Surgery:

No prior complete tumor resection

Trial locations and contacts

41 sites in 2 countries.

Country

City, postcode or hospital

41 sites in 2 countries

United States40 sites

Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, 62002
Ocean Medical Center at Meridian Health
Brick, New Jersey, 08724
Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Cape Girardeau, Missouri, 63701
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, 63703
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057
Alexian Brothers Radiation Oncology
Elk Grove Village, Illinois, 60007
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
University of Texas Medical Branch
Galveston, Texas, 77555-0361
Three Rivers Community Hospital
Grants Pass, Oregon, 97527
Oncology Center at Saint Margaret Mercy Healthcare Center
Hammond, Indiana, 46320
High Point Regional Hospital
High Point, North Carolina, 27261
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, 97504
Providence Cancer Center at PMCC
Medford, Oregon, 97504
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, 53295
Providence Holy Cross Cancer Center
Mission Hills, California, 91346-9600
Mobile Infirmary Medical Center
Mobile, Alabama, 36652-2144
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, 47303-3499
Bay Medical
Panama City, Florida, 32401
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, 39581
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141
Arizona Oncology Services Foundation
Phoenix, Arizona, 85013
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
University of California Davis Cancer Center
Sacramento, California, 95817
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, 63141
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, 08755
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, 08360
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, 26003
Cancer Treatment Center
Wooster, Ohio, 44691

Other trials in United States

Canada1 site

Tom Baker Cancer Centre - Calgary
Calgary, Alberta, T2N 4N2

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

OBJECTIVES:

Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when administered concurrently with paclitaxel and carboplatin in patients with inoperable stage IIIA or IIIB non-small cell lung cancer. (Phase I) (Closed to accrual as of 01/13/04.)
Determine the 12-month survival rate in patients treated with this regimen. (Phase II) (Closed to accrual as of 11/27/07.)
Determine the toxicity of this regimen in these patients.
Determine the partial organ tolerance doses for the lung and esophagus in patients treated with this regimen.
Determine the complete response rate in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of 3-dimensional conformal radiotherapy.

Phase I (closed to accrual as of 01/13/04): Patients undergo 3-dimensional conformal radiotherapy once daily five days a week for 7-8 weeks. Patients also receive concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43.

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.

Phase II: Additional patients are accrued and treated as above at the MTD. At least 3 weeks after completing radiotherapy, patients may receive additional chemotherapy comprising paclitaxel IV over 3 hours once and carboplatin IV over 30 minutes once. Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to 2 courses.

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.

Conditions: Lung Cancer
Being tested: carboplatin, paclitaxel, three-dimensional conformal radiation therapy
Keywords: squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer
Medical subject headings: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

carboplatinDrug
paclitaxelDrug
three-dimensional conformal radiation therapyRadiation

Study groups in NCT00023673
Study group	Role	What they receive
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. Receives: Drug: carboplatin; Drug: paclitaxel; Radiation: three-dimensional conformal radiation therapy
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. Receives: Drug: carboplatin; Drug: paclitaxel; Radiation: three-dimensional conformal radiation therapy
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. Receives: Drug: carboplatin; Drug: paclitaxel; Radiation: three-dimensional conformal radiation therapy
Phase II: 74 Gy/37 fx + chemotherapy	Experimental	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. Receives: Drug: carboplatin; Drug: paclitaxel; Radiation: three-dimensional conformal radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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%.
Measured: From registration to 1 year

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2001Nov 2013

First posted9 Apr 2003 (estimated)
Study startJul 2001
Primary completionJan 2009
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00023673
Sponsor's protocol ID: RTOG L-0117
Other IDs: CDR0000068850, NCI-2012-02401
Status last verified: Nov 2017
First submitted: 13 Sep 2001
Last updated: 22 Dec 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 20368547
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.
PubMed 20457350
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00023673
Acronym / sponsor ID: RTOG L-0117
Conditions: Lung Cancer
Keywords: squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Radiation Therapy Oncology GroupResearch network
Collaborators: National Cancer Institute (NCI)
Study start: Jul 2001
Primary completion: Jan 2009 (actual)
Study completion: Nov 2013 (actual)
First posted: 9 Apr 2003 (estimated)
Results: Posted 27 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

OBJECTIVES:

Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when administered concurrently with paclitaxel and carboplatin in patients with inoperable stage IIIA or IIIB non-small cell lung cancer. (Phase I) (Closed to accrual as of 01/13/04.)
Determine the 12-month survival rate in patients treated with this regimen. (Phase II) (Closed to accrual as of 11/27/07.)
Determine the toxicity of this regimen in these patients.
Determine the partial organ tolerance doses for the lung and esophagus in patients treated with this regimen.
Determine the complete response rate in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of 3-dimensional conformal radiotherapy.

Phase I (closed to accrual as of 01/13/04): Patients undergo 3-dimensional conformal radiotherapy once daily five days a week for 7-8 weeks. Patients also receive concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43.

Phase II: Additional patients are accrued and treated as above at the MTD. At least 3 weeks after completing radiotherapy, patients may receive additional chemotherapy comprising paclitaxel IV over 3 hours once and carboplatin IV over 30 minutes once. Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to 2 courses.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Phase I: 75.25 Gy/36 fx + chemotherapy	Experimental	Drug: carboplatin, Drug: paclitaxel, Radiation: three-dimensional conformal radiation therapyPhase 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	Drug: carboplatin, Drug: paclitaxel, Radiation: three-dimensional conformal radiation therapyPhase 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	Drug: carboplatin, Drug: paclitaxel, Radiation: three-dimensional conformal radiation therapyPhase 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	Experimental	Drug: carboplatin, Drug: paclitaxel, Radiation: three-dimensional conformal radiation therapyPhase 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
carboplatin	Drug	Phase I: 70 Gy/35 fx + chemotherapy, Phase I: 74 Gy/37 fx + chemotherapy, Phase I: 75.25 Gy/36 fx + chemotherapy, Phase II: 74 Gy/37 fx + chemotherapy
paclitaxel	Drug	Phase I: 70 Gy/35 fx + chemotherapy, Phase I: 74 Gy/37 fx + chemotherapy, Phase I: 75.25 Gy/36 fx + chemotherapy, Phase II: 74 Gy/37 fx + chemotherapy
three-dimensional conformal radiation therapy	Radiation	Phase I: 70 Gy/35 fx + chemotherapy, Phase I: 74 Gy/37 fx + chemotherapy, Phase I: 75.25 Gy/36 fx + chemotherapy, Phase II: 74 Gy/37 fx + chemotherapy

Primary outcome

Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy
Time frame: From start of treatment to 90 days
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
Percentage of Patients Who Survive at Least 12 Months
Time frame: From registration to 1 year
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%.

4 secondary outcomes

Frequency of Highest Grade Chemotherapy/Acute RT Toxicities and Late RT Toxicities.
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 27 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase I: 75.25 Gy/36 fx + Chemotherapy	8	8
Phase I: 74 Gy/37 fx + Chemotherapy	9	9
Phase I: 70 Gy/35 fx + Chemotherapy	0	0
Phase II: 74 Gy/37 fx + Chemotherapy	46	44

Primary outcome: Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy

Time frame: From start of treatment to 90 days. Number. Unit: units on a scale

Measure	Phase I: 75.25 Gy/36 fx + Chemotherapy n = 7	Phase I: 74 Gy/37 fx + Chemotherapy n = 7
Value	0	1

Population analysed: The first seven eligible patients who started protocol treatment at each dose level.

Primary outcome: Percentage of Patients Who Survive at Least 12 Months

Time frame: From registration to 1 year. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Phase I/II: 74 Gy/37 fx + Chemotherapy n = 53
Value	75.5 (61.5 to 85.0)

Population analysed: Eligible patients at the MTD dose level who started protocol treatment.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase I: 75.25 Gy/36 fx + Chemotherapy	7 of 8 (87.5%)	8 of 8 (100%)	Not reported
Phase I/II: 74 Gy/37 fx + Chemotherapy	36 of 53 (67.9%)	52 of 53 (98.1%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20368547Bradley 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.
Results publication: PubMed 20457350Bradley 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.
Results publicationBradley 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey Bradley, MD study chair

Mallinckrodt Institute of Radiology at Washington University Medical Center

41 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing carboplatin, paclitaxel and three-dimensional conformal radiation therapy in people with Lung Cancer, run by Radiation Therapy Oncology Group at 41 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy (time frame: From start of treatment to 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00023673, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.