Clinical trial NCT03099577: PET/CT-directed Hyperfractionated Radiation Dose Escalation in Stage III Non-small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: 1 year
Secondary outcomes:
measure: Time to Local Failure
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: the Ethic Committee of Shanghai General Hospital
Study officials:
affiliation: the ethic committee of shanghai genernal hospital
name: Tingfeng Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: