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CompletedNCT03099577Updated May 3, 2019

PET/CT-directed Hyperfractionated Radiation Dose Escalation in Stage III Non-small Cell Lung Cancer

An interventional study of radiochemotherapy 1 and radiochemotherapy 2 in Non Small Cell Lung Cancer, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-03.

Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Non Small Cell Lung Cancer
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 34 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 182 studies on the registry; 108 are open to participants now.

Browse Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
  2. Age 1 8-75.
  3. Zubrod performance status 0-2.
  4. Stage III ( American Joint Committee on Cancer AJCC, 7th ed.).
  5. No prior radiation to the thorax that would overlap with the current treatment field.
  6. 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.
  7. A signed informed consent must be obtained prior to therapy.
  8. Induction chemotherapy is allowed.
  9. Life expectancy more than 3 months.

Exclusion criteria

Exclusion Criteria:

  1. Patients with any component of small cell lung carcinoma are excluded from this study.
  2. Patients with evidence of a malignant pleural or pericardial effusion are excluded.
  3. Prior radiotherapy that would overlap the radiation fields.
  4. 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.
  5. Known hypersensitivity to paclitaxel.
  6. Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
  7. Acquired Immune Deficiency Syndrome.
  8. Conditions precluding medical follow-up and protocol compliance.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    radiochemotherapy 1

    Patients will be treated with radiation therapy 64.8 Gy

    Radiation: radiochemotherapy 1

  • Experimental
    radiochemotherapy 2

    Patients will be treated with radiation therapy 69.6 Gy

    Radiation: radiochemotherapy 2

  • Experimental
    radiochemotherapy 3

    Patients will be treated with radiation therapy 74.4 Gy

    Radiation: radiochemotherapy 3

  • Experimental
    radiochemotherapy 4

    Patients will be treated with radiation therapy 79.2 Gy

    Radiation: radiochemotherapy 4

  • Experimental
    radiochemotherapy 5

    Patients will be treated with radiation therapy 84 Gy

    Radiation: radiochemotherapy 5

  • Experimental
    radiochemotherapy 6

    Patients will be treated with radiation therapy 88.8 Gy

    Radiation: radiochemotherapy 6

  • Experimental
    radiochemotherapy 7

    Patients will be treated with radiation therapy 93.6 Gy

    Radiation: radiochemotherapy 7

Interventions

  • Radiationradiochemotherapy 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

    Also known as: concurrent chemoradiotherapy regimen 1

  • Radiationradiochemotherapy 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

    Also known as: concurrent chemoradiotherapy regimen 2

  • Radiationradiochemotherapy 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

    Also known as: concurrent chemoradiotherapy regimen 3

  • Radiationradiochemotherapy 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

    Also known as: concurrent chemoradiotherapy regimen 4

  • Radiationradiochemotherapy 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

    Also known as: concurrent chemoradiotherapy regimen 5

  • Radiationradiochemotherapy 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

    Also known as: concurrent chemoradiotherapy regimen 6

  • Radiationradiochemotherapy 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

    Also known as: concurrent chemoradiotherapy regimen 7

06

What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose

    Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity

    Time frame: 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

    Time frame: 2 years

07

Study locations

1 site
  • the Ethic Committee of Shanghai General Hospital
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Jun 2018, 17 months.

Of 305 non-industry interventional studies with no phase under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 123. This study's 17 months is below that.

Counting every sponsor, half of 320 studies reached it within 52 months; a quarter within 28 and three quarters within 123.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2017
First posted
Apr 4, 2017
StartActual
Jan 2, 2017
Primary completionActual
Jun 30, 2018
CompletionActual
Jun 30, 2018
Last update
May 3, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03099577
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Chen tingfeng (director,department of radiation, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Apr 4, 2017
Start date
Jan 2, 2017
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
May 3, 2019

Study contacts

Tingfeng Chen, MD
principal investigator · the ethic committee of shanghai genernal hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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