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

NCT ID: NCT03099577

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-02
• Study Completion Date: 2018-06-30

Brief 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).

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radiochemotherapy 1

Patients will be treated with radiation therapy 64.8 Gy

Group Type: EXPERIMENTAL

radiochemotherapy 1

Intervention Type: RADIATION

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

Patients will be treated with radiation therapy 69.6 Gy

Group Type: EXPERIMENTAL

radiochemotherapy 2

Intervention Type: RADIATION

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

Patients will be treated with radiation therapy 74.4 Gy

Group Type: EXPERIMENTAL

radiochemotherapy 3

Intervention Type: RADIATION

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

Patients will be treated with radiation therapy 79.2 Gy

Group Type: EXPERIMENTAL

radiochemotherapy 4

Intervention Type: RADIATION

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

Patients will be treated with radiation therapy 84 Gy

Group Type: EXPERIMENTAL

radiochemotherapy 5

Intervention Type: RADIATION

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

Patients will be treated with radiation therapy 88.8 Gy

Group Type: EXPERIMENTAL

radiochemotherapy 6

Intervention Type: RADIATION

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

Patients will be treated with radiation therapy 93.6 Gy

Group Type: EXPERIMENTAL

radiochemotherapy 7

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

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

Intervention Type: RADIATION

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

Intervention Type: RADIATION

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

Intervention Type: RADIATION

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

Intervention Type: RADIATION

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

Intervention Type: RADIATION

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

Intervention Type: RADIATION

Other Intervention Names

concurrent chemoradiotherapy regimen 1; concurrent chemoradiotherapy regimen 2; concurrent chemoradiotherapy regimen 3; concurrent chemoradiotherapy regimen 4; concurrent chemoradiotherapy regimen 5; concurrent chemoradiotherapy regimen 6; concurrent chemoradiotherapy regimen 7

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Chen tingfeng

director,department of radiation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tingfeng Chen, MD

Role: PRINCIPAL_INVESTIGATOR

the ethic committee of shanghai genernal hospital

Locations

the Ethic Committee of Shanghai General Hospital

Shanghai, , China

Countries

China

Other Identifiers

SGH201708

Identifier Type: -

Identifier Source: org_study_id