Non Small Cell Lung CancerNCT03099577
PET/CT-directed Hyperfractionated Radiation Dose Escalation in Stage III Non-small Cell Lung Cancer
A study testing radiochemotherapy 1, radiochemotherapy 2 and radiochemotherapy 3 in people with Non Small Cell Lung Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The goal of this study is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (carboplatin \& paclitaxel) in patients with stage III non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- radiochemotherapy 1, radiochemotherapy 2 and radiochemotherapy 3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2017to 30 Jun 2018
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
- Age 1 8-75.
- Zubrod performance status 0-2.
- Stage III ( American Joint Committee on Cancer AJCC, 7th ed.).
- No prior radiation to the thorax that would overlap with the current treatment field.
- Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/mm^3,absolute granulocyte count (AGC) ≥2 × 10^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine </=1 .5 times ULN.
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- A signed informed consent must be obtained prior to therapy.
- Induction chemotherapy is allowed.
- Life expectancy more than 3 months.
Who cannot join
- Patients with any component of small cell lung carcinoma are excluded from this study.
- Patients with evidence of a malignant pleural or pericardial effusion are excluded.
- Prior radiotherapy that would overlap the radiation fields.
- Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
- Known hypersensitivity to paclitaxel.
- Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
- Acquired Immune Deficiency Syndrome.
- Conditions precluding medical follow-up and protocol compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of PET/CT-directed Hyperfractionated Radiation Dose Escalation With Concurrent Weekly Carboplatin and Paclitaxel in Stage III Non-small Cell Lung Cancer
The goal of this study is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (carboplatin \& paclitaxel) in patients with stage III non-small cell lung cancer (NSCLC).
Read the detailed description
Concurrent chemoradiotherapy is the standard of care for unresectable stage III NSCLC based on the results of phase III randomised trials. The current standard radiation therapy dose has remained 60- Gy at -2 Gy/fraction for nearly four decades (60Gy), with local disease control rates of approximately 50% and a median overall survival of only 18 months.These results are suboptimal and more effective treatment regimens are needed.
We hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by positron emission tomography (PET) /computed tomography (CT) would improve local control and overall survival while reducing the acute and late normal tissue toxicity.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- radiochemotherapy 1, radiochemotherapy 2, radiochemotherapy 3, radiochemotherapy 4, radiochemotherapy 5
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiochemotherapy 1Radiation
Also called concurrent chemoradiotherapy regimen 1
concurrent radiochemotherapy: radiotherapy dose level 1: 60 Gy at 2 Gy/Fx/d, then 4.8 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
radiochemotherapy 2Radiation
Also called concurrent chemoradiotherapy regimen 2
concurrent radiochemotherapy: radiotherapy dose level 2: 60 Gy at 2 Gy/Fx/d, then 9.6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
radiochemotherapy 3Radiation
Also called concurrent chemoradiotherapy regimen 3
concurrent radiochemotherapy: radiotherapy dose level 3: 60 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
radiochemotherapy 4Radiation
Also called concurrent chemoradiotherapy regimen 4
concurrent radiochemotherapy: radiotherapy dose level 4: 60 Gy at 2 Gy/Fx/d, then 19.2 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
radiochemotherapy 5Radiation
Also called concurrent chemoradiotherapy regimen 5
concurrent radiochemotherapy: radiotherapy dose level 5: 60 Gy at 2 Gy/Fx/d, then 4.8x5 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
radiochemotherapy 6Radiation
Also called concurrent chemoradiotherapy regimen 6
concurrent radiochemotherapy: radiotherapy dose level 6: 60 Gy at 2 Gy/Fx/d, then 4.8x6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
radiochemotherapy 7Radiation
Also called concurrent chemoradiotherapy regimen 7
concurrent radiochemotherapy: radiotherapy dose level 7: 60 Gy at 2 Gy/Fx/d, then 4.8x7 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
| Study group | Role | What they receive |
|---|---|---|
| radiochemotherapy 1 | Experimental | Patients will be treated with radiation therapy 64.8 Gy Receives: Radiation: radiochemotherapy 1 |
| radiochemotherapy 2 | Experimental | Patients will be treated with radiation therapy 69.6 Gy Receives: Radiation: radiochemotherapy 2 |
| radiochemotherapy 3 | Experimental | Patients will be treated with radiation therapy 74.4 Gy Receives: Radiation: radiochemotherapy 3 |
| radiochemotherapy 4 | Experimental | Patients will be treated with radiation therapy 79.2 Gy Receives: Radiation: radiochemotherapy 4 |
| radiochemotherapy 5 | Experimental | Patients will be treated with radiation therapy 84 Gy Receives: Radiation: radiochemotherapy 5 |
| radiochemotherapy 6 | Experimental | Patients will be treated with radiation therapy 88.8 Gy Receives: Radiation: radiochemotherapy 6 |
| radiochemotherapy 7 | Experimental | Patients will be treated with radiation therapy 93.6 Gy Receives: Radiation: radiochemotherapy 7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity
Measured: 1 year
Secondary outcomes (1)
Time to Local Failure
Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start2 Jan 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
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 Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen tingfeng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Tingfeng Chen, MD, Principal investigator, the ethic committee of shanghai genernal hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099577
- Sponsor's protocol ID
- SGH201708
- Status last verified
- Mar 2018
- First submitted
- 28 Mar 2017
- Last updated
- 3 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of PET/CT-directed Hyperfractionated Radiation Dose Escalation With Concurrent Weekly Carboplatin and Paclitaxel in Stage III Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03099577
- Acronym / sponsor ID
- SGH201708
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
The goal of this study is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (carboplatin \& paclitaxel) in patients with stage III non-small cell lung cancer (NSCLC).
Detailed description
Concurrent chemoradiotherapy is the standard of care for unresectable stage III NSCLC based on the results of phase III randomised trials. The current standard radiation therapy dose has remained 60- Gy at -2 Gy/fraction for nearly four decades (60Gy), with local disease control rates of approximately 50% and a median overall survival of only 18 months.These results are suboptimal and more effective treatment regimens are needed.
We hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by positron emission tomography (PET) /computed tomography (CT) would improve local control and overall survival while reducing the acute and late normal tissue toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| radiochemotherapy 1 | Experimental | Radiation: radiochemotherapy 1Patients will be treated with radiation therapy 64.8 Gy |
| radiochemotherapy 2 | Experimental | Radiation: radiochemotherapy 2Patients will be treated with radiation therapy 69.6 Gy |
| radiochemotherapy 3 | Experimental | Radiation: radiochemotherapy 3Patients will be treated with radiation therapy 74.4 Gy |
| radiochemotherapy 4 | Experimental | Radiation: radiochemotherapy 4Patients will be treated with radiation therapy 79.2 Gy |
| radiochemotherapy 5 | Experimental | Radiation: radiochemotherapy 5Patients will be treated with radiation therapy 84 Gy |
| radiochemotherapy 6 | Experimental | Radiation: radiochemotherapy 6Patients will be treated with radiation therapy 88.8 Gy |
| radiochemotherapy 7 | Experimental | Radiation: radiochemotherapy 7Patients will be treated with radiation therapy 93.6 Gy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
- Age 1 8-75.
- Zubrod performance status 0-2.
- Stage III ( American Joint Committee on Cancer AJCC, 7th ed.).
- No prior radiation to the thorax that would overlap with the current treatment field.
Key exclusion criteria (8 listed)
- Patients with any component of small cell lung carcinoma are excluded from this study.
- Patients with evidence of a malignant pleural or pericardial effusion are excluded.
- Prior radiotherapy that would overlap the radiation fields.
- Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
- Known hypersensitivity to paclitaxel.
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 |
|---|---|---|
| radiochemotherapy 1Also: concurrent chemoradiotherapy regimen 1concurrent radiochemotherapy: radiotherapy dose level 1: 60 Gy at 2 Gy/Fx/d, then 4.8 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly | Radiation | radiochemotherapy 1 |
| radiochemotherapy 2Also: concurrent chemoradiotherapy regimen 2concurrent radiochemotherapy: radiotherapy dose level 2: 60 Gy at 2 Gy/Fx/d, then 9.6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly | Radiation | radiochemotherapy 2 |
| radiochemotherapy 3Also: concurrent chemoradiotherapy regimen 3concurrent radiochemotherapy: radiotherapy dose level 3: 60 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly | Radiation | radiochemotherapy 3 |
| radiochemotherapy 4Also: concurrent chemoradiotherapy regimen 4concurrent radiochemotherapy: radiotherapy dose level 4: 60 Gy at 2 Gy/Fx/d, then 19.2 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly | Radiation | radiochemotherapy 4 |
| radiochemotherapy 5Also: concurrent chemoradiotherapy regimen 5concurrent radiochemotherapy: radiotherapy dose level 5: 60 Gy at 2 Gy/Fx/d, then 4.8x5 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly | Radiation | radiochemotherapy 5 |
| radiochemotherapy 6Also: concurrent chemoradiotherapy regimen 6concurrent radiochemotherapy: radiotherapy dose level 6: 60 Gy at 2 Gy/Fx/d, then 4.8x6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly | Radiation | radiochemotherapy 6 |
| radiochemotherapy 7Also: concurrent chemoradiotherapy regimen 7concurrent radiochemotherapy: radiotherapy dose level 7: 60 Gy at 2 Gy/Fx/d, then 4.8x7 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly | Radiation | radiochemotherapy 7 |
Primary outcome
Maximum Tolerated Dose
Time frame: 1 year
Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity
1 secondary outcome
Time to Local Failure
Time frame: 2 years
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 3 May 2019.
- Individual participant dataSharing planned: No
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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.
Tingfeng Chen, MD principal investigator
the ethic committee of shanghai genernal hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiochemotherapy 1, radiochemotherapy 2 and radiochemotherapy 3 in people with Non Small Cell Lung Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 9 inclusion and 8 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 3 May 2019. 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 China. 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.
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?
Maximum Tolerated Dose (time frame: 1 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 3 May 2019.