Non-small-cell Lung CancerPhase 4NCT00686322
Concurrent Chemoradiotherapy (CCRT) With Paclitaxel Plus Cisplatin in LA Non-small-cell Lung Cancer (NSCLC)
A Phase 4 study testing Concurrent chemoradiotherapy (paclitaxel plus cisplatin plus radiotherapy) in people with Non-small-cell Lung Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Present study is to investigate efficacy and toxicity profiles of induction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consolidation chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small-cell Lung Cancer
- What is being tested?
- Concurrent chemoradiotherapy (paclitaxel plus cisplatin plus radiotherapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2008to Oct 2009
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytological diagnosis of inoperable locally advanced (stage III) NSCLC.
- No prior chemotherapy, immunotherapy, or radiotherapy.
- Performance status of 0 to 2 on the Zubrod scale.
- Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. Lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by computerized tomography (CT) scan, magnetic resonance imaging (MRI), or chest x-ray.
- Estimated life expectancy of at least 12 weeks.
- Patient compliance and geographic proximity that allow adequate follow-up.
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- Adequate bone marrow reserve: white blood cell (WBC) count *4,000/mm3, platelets >100,000/mm3, and hemoglobin *10 g/dL.
- Informed consent from patient.
- Males or females 18 years of age or older.
- If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device [IUD], birth control pills, or barrier device) during and for three months after trial.
Who cannot join
- Active infection (at the discretion of the investigator).
- Inadequate liver function (total bilirubin >1.5 times above normal range); alanine transaminase (ALT) and aspartate transaminase (AST) greater than 3 times normal (ALT and AST may be elevated to 5 times normal in patients with known metastatic disease in the liver).
- Inadequate renal function (creatinine >2.0 mg/dL).
- Pregnancy or not using appropriate birth control during the study.
- Breast feeding.
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
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- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- Use of any investigational agent in the month before enrollment into the study.
- Patients with leukemia and/or a secondary primary carcinoma except for patients who have had curative therapy to basal cell carcinoma.
- Concomitant myelosuppressive radiotherapy, chemotherapy, hormonal therapy, or immunotherapy will not be allowed except as previously noted for radiation.
- Active cardiac disease requiring therapy for failure, angina, and/or arrhythmias; infarctions within the preceding six months (exception: any patient whose cardiac failure is compensated on medications).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study of Concurrent Chemoradiotherapy With Paclitaxel and Cisplatin in Previously Untreated, Inoperable (Stage IIIa or IIIb) Non-small-cell Lung Cancer
Present study is to investigate efficacy and toxicity profiles of induction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consolidation chemotherapy.
Read the detailed description
Lung cancer is a major cause of cancer death in Taiwan and throughout the world in both developed and developing countries. More than 75% of NSCLC patients are inoperable because of either distantly metastatic disease or disease confined to one hemithorax with one or more criteria of unresectability at the time of presentation. The prognosis of such inoperable metastatic patients is poor.
The benefit of adding chemotherapy to radiation therapy for stage III disease of NSCLC is well-established. The largest of the prospective trials was sponsored by the Radiation Therapy Oncology Group (RTOG), ECOG, and the Southwest Oncology Group (SWOG), and allocated 490 patients to receive 2 months of cisplatin + vinblastine chemotherapy followed by 60 Gy of radiation at 2 Gy per fraction; or one of two radiation-alone arms. Overall survival was statistically superior for the patients receiving chemotherapy and radiation versus the other two arms of the study (13.2 months vs 12 months, vs 11.4 months, respectively; p=0.04).
Administration of chemotherapy concurrently with radiation therapy theoretically improves local control by sensitizing the tumor to radiation, while simultaneously treating systemic disease, albeit at the expense of greater local toxicity. Two large phase III studies suggest improvement in both local control and survival with concurrent chemoradiotherapy as compared with sequential chemotherapy followed by radiation for patients with stage III NSCLC. Although rates of nonhematologic toxicity were higher on the concurrent arms, median survival time trended toward superiority in the concomitant chemotherapy plus daily radiation arm compared with the sequential arm.
One source of debate is whether the addition of induction or consolidation chemotherapy adds anything to concomitant chemoradiotherapy, with numerous intergroup trials underway. CALGB has completed a randomized phase II study of two cycles of induction chemotherapy followed by two additional cycles of the same drugs with concomitant radiotherapy. The three treatment arms included four cycles of cisplatin (80 mg/m2) combined with either gemcitabine, paclitaxel, or vinorelbine. Radiotherapy was completed during the last two cycles to a total of 66 Gy. Response rates were similar, and median survival for all patients was 17 months with no clearly superior arm evident in this randomized phase II trial.
We proposed this clinical trial to evaluate the efficacy and toxicity profile of combination chemotherapy with paclitaxel and cisplatin in previously untreated, stage IIIa/IIIb NSCLC patients who received 1 cycle of induction chemotherapy, followed by concurrent chemoradiotherapy, with 2 cycles of consolidation chemotherapy.
- Conditions
- Non-small-cell Lung Cancer
- Being tested
- Concurrent chemoradiotherapy (paclitaxel plus cisplatin plus radiotherapy)
- Keywords
- chemotherapy, radiotherapy, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent chemoradiotherapy (paclitaxel plus cisplatin plus radiotherapy)Drug
Also called paclitaxel, cisplatin
Induction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consolidation chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Induction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consolidation chemotherapy. Receives: Drug: Concurrent chemoradiotherapy (paclitaxel plus cisplatin plus radiotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of this treatment modality in patients with inoperable stage III NSCLC
Measured: one year
Secondary outcomes (1)
To determine the toxicity profiles of this treatment modality in patients with inoperable stage III NSCLC
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yuh-Min Chen, MD, PhD., Principal investigator, Chest Department, Taipei VGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686322
- Sponsor's protocol ID
- 97-02-12
- Status last verified
- Jun 2010
- First submitted
- 27 May 2008
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Concurrent Chemoradiotherapy With Paclitaxel and Cisplatin in Previously Untreated, Inoperable (Stage IIIa or IIIb) Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00686322
- Acronym / sponsor ID
- 97-02-12
- Conditions
- Non-small-cell Lung Cancer
- Keywords
- chemotherapy, radiotherapy, lung cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 29 May 2008 (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.
Present study is to investigate efficacy and toxicity profiles of induction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consolidation chemotherapy.
Detailed description
Lung cancer is a major cause of cancer death in Taiwan and throughout the world in both developed and developing countries. More than 75% of NSCLC patients are inoperable because of either distantly metastatic disease or disease confined to one hemithorax with one or more criteria of unresectability at the time of presentation. The prognosis of such inoperable metastatic patients is poor.
The benefit of adding chemotherapy to radiation therapy for stage III disease of NSCLC is well-established. The largest of the prospective trials was sponsored by the Radiation Therapy Oncology Group (RTOG), ECOG, and the Southwest Oncology Group (SWOG), and allocated 490 patients to receive 2 months of cisplatin + vinblastine chemotherapy followed by 60 Gy of radiation at 2 Gy per fraction; or one of two radiation-alone arms. Overall survival was statistically superior for the patients receiving chemotherapy and radiation versus the other two arms of the study (13.2 months vs 12 months, vs 11.4 months, respectively; p=0.04).
Administration of chemotherapy concurrently with radiation therapy theoretically improves local control by sensitizing the tumor to radiation, while simultaneously treating systemic disease, albeit at the expense of greater local toxicity. Two large phase III studies suggest improvement in both local control and survival with concurrent chemoradiotherapy as compared with sequential chemotherapy followed by radiation for patients with stage III NSCLC. Although rates of nonhematologic toxicity were higher on the concurrent arms, median survival time trended toward superiority in the concomitant chemotherapy plus daily radiation arm compared with the sequential arm.
One source of debate is whether the addition of induction or consolidation chemotherapy adds anything to concomitant chemoradiotherapy, with numerous intergroup trials underway. CALGB has completed a randomized phase II study of two cycles of induction chemotherapy followed by two additional cycles of the same drugs with concomitant radiotherapy. The three treatment arms included four cycles of cisplatin (80 mg/m2) combined with either gemcitabine, paclitaxel, or vinorelbine. Radiotherapy was completed during the last two cycles to a total of 66 Gy. Response rates were similar, and median survival for all patients was 17 months with no clearly superior arm evident in this randomized phase II trial.
We proposed this clinical trial to evaluate the efficacy and toxicity profile of combination chemotherapy with paclitaxel and cisplatin in previously untreated, stage IIIa/IIIb NSCLC patients who received 1 cycle of induction chemotherapy, followed by concurrent chemoradiotherapy, with 2 cycles of consolidation chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Concurrent chemoradiotherapy (paclitaxel plus cisplatin plus radiotherapy)Induction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consolidation chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologic or cytological diagnosis of inoperable locally advanced (stage III) NSCLC.
- No prior chemotherapy, immunotherapy, or radiotherapy.
- Performance status of 0 to 2 on the Zubrod scale.
- Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. Lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by computerized tomography (CT) scan, magnetic resonance imaging (MRI), or chest x-ray.
- Estimated life expectancy of at least 12 weeks.
Key exclusion criteria (11 listed)
- Active infection (at the discretion of the investigator).
- Inadequate liver function (total bilirubin >1.5 times above normal range); alanine transaminase (ALT) and aspartate transaminase (AST) greater than 3 times normal (ALT and AST may be elevated to 5 times normal in patients with known metastatic disease in the liver).
- Inadequate renal function (creatinine >2.0 mg/dL).
- Pregnancy or not using appropriate birth control during the study.
- Breast feeding.
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 |
|---|---|---|
| Concurrent chemoradiotherapy (paclitaxel plus cisplatin plus radiotherapy)Also: paclitaxel, cisplatinInduction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consolidation chemotherapy. | Drug | 1 |
Primary outcome
To determine the efficacy of this treatment modality in patients with inoperable stage III NSCLC
Time frame: one year
1 secondary outcome
To determine the toxicity profiles of this treatment modality in patients with inoperable stage III NSCLC
Time frame: one year
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 15 Sep 2011.
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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.
Yuh-Min Chen, MD, PhD. principal investigator
Chest Department, Taipei VGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Concurrent chemoradiotherapy (paclitaxel plus cisplatin plus radiotherapy) in people with Non-small-cell Lung Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 efficacy of this treatment modality in patients with inoperable stage III NSCLC (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2011.