Clinical trial NCT01494415: Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer
Official title: A Phase II Study of Concurrent Nab-Paclitaxel, Carboplatin and Thoracic Radiotherapy in Local Advanced Squamous Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Keywords: Squamous Cell Lung Cancer
radiation therapy
chemotherapy
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2011-12-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. The regimen of weekly nab-paclitaxel, carboplatin and concurrent radiotherapy was well tolerated in a phase I study. Given nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced squamous cell lung cancer may have promising result.

Detailed description: This study was conducted to explore the efficacy and toxicity of concurrent chemoradiotherapy with nab-paclitaxel, carboplatin and thoracic radiotherapy in unresectable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 60mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 66 Gy/33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed. Two cycles of consolidation therapy with full dose nab-paclitaxel (260 mg/m2 on day 1) and carboplatin (AUC 6 on day 1) every 21 day will be delivered.

Eligibility criteria: Inclusion Criteria:

* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
* Previously untreated, histological documented, inoperable stage IIIA or IIIB squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
* Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
* Weight loss ≦ 5% in the previous six months.
* Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
* Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
* Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

* Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
* Previous chemotherapy or previous biologic response modifiers for current lung cancer.
* Patient has previously had thoracic radiation therapy.
* Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
* Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
* History of significant neurological or mental disorder, including seizures or dementia.

Primary outcomes:
measure: tumor response rate
timeFrame: one month after the end of all treatment
Secondary outcomes:
measure: progression-free survival
timeFrame: 2 years from patient enrollment
measure: overall survival
timeFrame: 2 years from patient enrollment
measure: esophagitis
timeFrame: 6 mouths from the initiation of treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The First People's Hospital of Hangzhou
state: Zhejiang
Study officials:
affiliation: The First People's Hospital of Hangzhou
name: Shenglin Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: