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

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099577
• Other study ID #: SGH201708
• Status: Completed
• Phase: N/A
• Start date: January 2, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2018
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Radiation:
• radiochemotherapy 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 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 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 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 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 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 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

Locations

Country	Name	City	State
China	the Ethic Committee of Shanghai General Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose	Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity	1 year
Secondary	Time to Local Failure	Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan	2 years