Lung CancerPhase 1NCT00016315
Gemcitabine, Carboplatin or Paclitaxel Plus Radiation Therapy in Treating Patients With Stage IIIA or IIIB Non-Small Cell Lung Cancer
A Phase 1 study testing carboplatin, gemcitabine hydrochloride and paclitaxel in people with Lung Cancer, run by Radiation Therapy Oncology Group at 19 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- carboplatin, gemcitabine hydrochloride and paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 19 sitesUnited States
- Study dates
- May 2001to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 loco-regionally advanced non-small cell lung cancer meeting one of the following staging criteria:
- Medically inoperable stage IIIA
- Unresectable stage IIIA or IIIB
- Measurable disease on three-dimensional planning CT scan
- No post-resection intrathoracic tumor recurrence
- No pleural effusion on chest x-ray except those occurring after attempted thoracotomy or other invasive thoracic procedure
- No evidence of small cell histology
- No evidence of hematogenous or distant metastases
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least 100,000/mm^3
- Absolute granulocyte count at least 2,000/mm^3
- Hemoglobin at least 8.0 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- Serum glutamate oxaloacetate transaminase (SGOT) no greater than 1.5 times upper limit of normal (unless caused by documented benign disease)
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No myocardial infarction within the past 6 months
- No symptomatic heart disease, including angina, congestive heart failure, or uncontrolled arrhythmia
Pulmonary:
- Forced expiratory volume (FEV)_1 greater than 1,000 mL
Other:
- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
- No weight loss of more than 10% in 3 months prior to diagnosis
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior thoracic or neck radiotherapy
Surgery:
- See Disease Characteristics
- No prior complete or subtotal tumor resection
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Akron City Hospital
Akron, Ohio, 44304
Danville Regional Medical Center
Danville, Virginia, 24541
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, 52001
Dale and Frances Hughes Cancer Center
East Stroudsburg, Pennsylvania, 18301
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
Cottonwood Hospital Medical Center
Murray, Utah, 84107
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-5671
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
McKay-Dee Hospital Center
Ogden, Utah, 84403
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
Cancer Care Center, Incorporated
Salem, Ohio, 44460
LDS Hospital
Salt Lake City, Utah, 84143
Dixie Regional Medical Center
St. George, Utah, 84770
About this study
Official title: A Phase I Study of Gemcitabine, Carboplatin or Gemcitabine, Paclitaxel and Radiation Therapy Followed by Adjuvant Chemotherapy for Patients With Favorable Prognosis Inoperable Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining combination chemotherapy with radiation therapy in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of gemcitabine when administered with carboplatin and thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in patients with stage IIIA or IIIB non-small cell lung cancer.
- Determine the MTD of gemcitabine and paclitaxel when administered with thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in these patients.
OUTLINE: This is a multicenter, dose-escalation study of gemcitabine and paclitaxel. Patients are sequentially assigned to 1 of 3 treatment regimens.
- Regimen A: Patients receive gemcitabine IV over 30-60 minutes on days 1, 8, 22, 29, and 43 and thoracic radiotherapy daily 5 days a week for 7 weeks beginning on day 1.
- Regimen B (closed to accrual as of 5/13/03): Patients receive gemcitabine and thoracic radiotherapy as in regimen A and carboplatin IV over 30 minutes on days 1, 8, 22, 29, and 43.
- Regimen C: Patients receive gemcitabine and thoracic radiotherapy as in regimen A and paclitaxel IV over 1 hour on days 1, 8, 22, 29, and 43.
At 3 weeks after completion of chemoradiotherapy, all patients receive adjuvant gemcitabine IV over 30-60 minutes on days 71, 78, 92, and 99 and carboplatin IV over 30 minutes on days 71 and 92.
The first 6 patients enrolled receive regimen A to determine the safety of the initial dose of gemcitabine. After completion of regimen A, cohorts of 3-6 patients receive escalating doses of gemcitabine in regimen B (closed to accrual as of 5/13/03) until the maximum tolerated dose (MTD) is determined. In a separate sequence, cohorts of 3-6 patients receive alternating escalating doses of gemcitabine and paclitaxel in regimen C until the MTD is determined. The MTD is defined as the dose preceding that at which at least 3 of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 months, 6 months, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 29 months.
- Conditions
- Lung Cancer
- Being tested
- carboplatin, gemcitabine hydrochloride, paclitaxel, radiation therapy
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
paclitaxelDrug
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Sequence A: Gemcitabine 300 mg/m2/week plus radiation therapy (RT) Receives: Drug: gemcitabine hydrochloride; Radiation: radiation therapy |
| Arm 2 | Experimental | Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT Receives: Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: radiation therapy |
| Arm 3 | Experimental | Sequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT Receives: Drug: carboplatin; Drug: gemcitabine hydrochloride; Radiation: radiation therapy |
| Arm 4 | Experimental | Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT Receives: Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: radiation therapy |
| Arm 6 | Experimental | Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT Receives: Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: radiation therapy |
| Arm 8 | Experimental | Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT Receives: Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: radiation therapy |
| Arm 10 | Experimental | Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT Receives: Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: radiation therapy |
| Arm 12 | Experimental | Sequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT Receives: Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: radiation therapy |
| Arm 14 | Experimental | Sequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT Receives: Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: radiation therapy |
| Arm 5 | Experimental | Sequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT Receives: Drug: carboplatin; Drug: gemcitabine hydrochloride; Radiation: radiation therapy |
| Arm 7 | Experimental | Sequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT Receives: Drug: carboplatin; Drug: gemcitabine hydrochloride; Radiation: radiation therapy |
| Arm 9 | Experimental | Sequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT Receives: Drug: carboplatin; Drug: gemcitabine hydrochloride; Radiation: radiation therapy |
| Arm 11 | Experimental | Sequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT Receives: Drug: carboplatin; Drug: gemcitabine hydrochloride; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose of gemcitabine with carboplatin-based chemotherapy and radiation therapy
Measured: From start of treatment to 90 days
To determine the maximum tolerated dose of gemcitabine with paclitaxel-based chemotherapy and radiation therapy
Measured: From start of treatment to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startMay 2001
- Primary completionJan 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hak Choy, MD, Study chair, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016315
- Sponsor's protocol ID
- RTOG-0017
- Other IDs
- RTOG-L-0017, CDR0000068622
- Status last verified
- Nov 2015
- First submitted
- 6 May 2001
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Choy H, Jain AK, Moughan J, Curran W, Whipple G, Demas WF, Ettinger DS. RTOG 0017: a phase I trial of concurrent gemcitabine/carboplatin or gemcitabine/paclitaxel and radiation therapy ("ping-pong trial") followed by adjuvant chemotherapy for patients with favorable prognosis inoperable stage IIIA/B non-small cell lung cancer. J Thorac Oncol. 2009 Jan;4(1):80-6. doi: 10.1097/JTO.0b013e318191503f.
PubMed 19096311Choy H, Swann S, Curran W, et al.: A phase I trial of gemcitabine, carboplatin or gemcitabine, paclitaxel and concurrent radiation therapy followed by consolidative gemcitabine and carboplatin for inoperable stage III non-small cell lung cancer: an RTOG 0017 study. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-70, S42, 2005.
Choy H, Swann S, Walter C, et al.: A phase I trial of gemcitabine, carboplatin or gemcitabine, paclitaxel and concurrent radiation therapy followed by consolidative gemcitabine and carboplatin for inoperable stage III non-small cell lung cancer: an RTOG study. [Abstract] J Clin Oncol 23 (Suppl 16): A-7103, 646s, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Gemcitabine, Carboplatin or Gemcitabine, Paclitaxel and Radiation Therapy Followed by Adjuvant Chemotherapy for Patients With Favorable Prognosis Inoperable Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00016315
- Acronym / sponsor ID
- RTOG-0017
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2001
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 7 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining combination chemotherapy with radiation therapy in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of gemcitabine when administered with carboplatin and thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in patients with stage IIIA or IIIB non-small cell lung cancer.
- Determine the MTD of gemcitabine and paclitaxel when administered with thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in these patients.
OUTLINE: This is a multicenter, dose-escalation study of gemcitabine and paclitaxel. Patients are sequentially assigned to 1 of 3 treatment regimens.
- Regimen A: Patients receive gemcitabine IV over 30-60 minutes on days 1, 8, 22, 29, and 43 and thoracic radiotherapy daily 5 days a week for 7 weeks beginning on day 1.
- Regimen B (closed to accrual as of 5/13/03): Patients receive gemcitabine and thoracic radiotherapy as in regimen A and carboplatin IV over 30 minutes on days 1, 8, 22, 29, and 43.
- Regimen C: Patients receive gemcitabine and thoracic radiotherapy as in regimen A and paclitaxel IV over 1 hour on days 1, 8, 22, 29, and 43.
At 3 weeks after completion of chemoradiotherapy, all patients receive adjuvant gemcitabine IV over 30-60 minutes on days 71, 78, 92, and 99 and carboplatin IV over 30 minutes on days 71 and 92.
The first 6 patients enrolled receive regimen A to determine the safety of the initial dose of gemcitabine. After completion of regimen A, cohorts of 3-6 patients receive escalating doses of gemcitabine in regimen B (closed to accrual as of 5/13/03) until the maximum tolerated dose (MTD) is determined. In a separate sequence, cohorts of 3-6 patients receive alternating escalating doses of gemcitabine and paclitaxel in regimen C until the MTD is determined. The MTD is defined as the dose preceding that at which at least 3 of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 months, 6 months, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 29 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: gemcitabine hydrochloride, Radiation: radiation therapySequence A: Gemcitabine 300 mg/m2/week plus radiation therapy (RT) |
| Arm 2 | Experimental | Drug: gemcitabine hydrochloride, Drug: paclitaxel, Radiation: radiation therapySequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT |
| Arm 3 | Experimental | Drug: carboplatin, Drug: gemcitabine hydrochloride, Radiation: radiation therapySequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT |
| Arm 4 | Experimental | Drug: gemcitabine hydrochloride, Drug: paclitaxel, Radiation: radiation therapySequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT |
| Arm 6 | Experimental | Drug: gemcitabine hydrochloride, Drug: paclitaxel, Radiation: radiation therapySequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT |
| Arm 8 | Experimental | Drug: gemcitabine hydrochloride, Drug: paclitaxel, Radiation: radiation therapySequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT |
| Arm 10 | Experimental | Drug: gemcitabine hydrochloride, Drug: paclitaxel, Radiation: radiation therapySequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT |
| Arm 12 | Experimental | Drug: gemcitabine hydrochloride, Drug: paclitaxel, Radiation: radiation therapySequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT |
| Arm 14 | Experimental | Drug: gemcitabine hydrochloride, Drug: paclitaxel, Radiation: radiation therapySequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT |
| Arm 5 | Experimental | Drug: carboplatin, Drug: gemcitabine hydrochloride, Radiation: radiation therapySequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT |
| Arm 7 | Experimental | Drug: carboplatin, Drug: gemcitabine hydrochloride, Radiation: radiation therapySequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT |
| Arm 9 | Experimental | Drug: carboplatin, Drug: gemcitabine hydrochloride, Radiation: radiation therapySequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT |
| Arm 11 | Experimental | Drug: carboplatin, Drug: gemcitabine hydrochloride, Radiation: radiation therapySequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT |
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 | Arm 11, Arm 3, Arm 5, Arm 7, Arm 9 |
| gemcitabine hydrochloride | Drug | Arm 1, Arm 10, Arm 11, Arm 12, Arm 14, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6, Arm 7, Arm 8, Arm 9 |
| paclitaxel | Drug | Arm 10, Arm 12, Arm 14, Arm 2, Arm 4, Arm 6, Arm 8 |
| radiation therapy | Radiation | Arm 1, Arm 10, Arm 11, Arm 12, Arm 14, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6, Arm 7, Arm 8, Arm 9 |
Primary outcome
To determine the maximum tolerated dose of gemcitabine with carboplatin-based chemotherapy and radiation therapy
Time frame: From start of treatment to 90 days
To determine the maximum tolerated dose of gemcitabine with paclitaxel-based chemotherapy and radiation therapy
Time frame: From start of treatment to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
- Results publication: PubMed 19096311Choy H, Jain AK, Moughan J, Curran W, Whipple G, Demas WF, Ettinger DS. RTOG 0017: a phase I trial of concurrent gemcitabine/carboplatin or gemcitabine/paclitaxel and radiation therapy ("ping-pong trial") followed by adjuvant chemotherapy for patients with favorable prognosis inoperable stage IIIA/B non-small cell lung cancer. J Thorac Oncol. 2009 Jan;4(1):80-6. doi: 10.1097/JTO.0b013e318191503f.
- Results publicationChoy H, Swann S, Curran W, et al.: A phase I trial of gemcitabine, carboplatin or gemcitabine, paclitaxel and concurrent radiation therapy followed by consolidative gemcitabine and carboplatin for inoperable stage III non-small cell lung cancer: an RTOG 0017 study. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-70, S42, 2005.
- Results publicationChoy H, Swann S, Walter C, et al.: A phase I trial of gemcitabine, carboplatin or gemcitabine, paclitaxel and concurrent radiation therapy followed by consolidative gemcitabine and carboplatin for inoperable stage III non-small cell lung cancer: an RTOG study. [Abstract] J Clin Oncol 23 (Suppl 16): A-7103, 646s, 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.
Hak Choy, MD study chair
Simmons Cancer Center
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing carboplatin, gemcitabine hydrochloride and paclitaxel in people with Lung Cancer, run by Radiation Therapy Oncology Group at 19 sites in United States.
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 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the maximum tolerated dose of gemcitabine with carboplatin-based chemotherapy and radiation therapy (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 NCT00016315, 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 17 Nov 2015.