Cisplatin/Etoposide/Radiotherapy +/- Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Cisplatin; Etoposide; Radiation; Docetaxel
Intervention description: Cisplatin 50 mg/m2 day 1, 8, 29, 36; Etoposide 50 mg/m2, days 1-5, 29-33; Radiation 5940 cGy (180 cGy/day); docetaxel 75mg/m2 q3wk x 3 cycles
Intervention MeSH terms: Docetaxel; Etoposide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer

Summary:

      In a previous phase II study, patients with pathological stage IIIb (without pleural
      effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic
      radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was
      selected based upon a survival benefit in patients with recurrent NSCLC.

      This trial will evaluate the role of consolidation therapy with docetaxel in patients with
      unresectable stage III disease. The purpose of the trial is to evaluate survival and
      toxicities of the regimens employed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic evidence of NSCLCUnresectable Stage IIIA (N2) OR Stage IIIB
             NSCLC.

          -  Unresectable Stage IIIA will be defined by the following criteria:

          -  N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan such that in the
             opinion of the treating investigator, the patient is not a candidate for surgical
             resection

          -  N2 disease must be documented by biopsy, FDG-PET scan imaging, or by CT if nodes are >
             2 cm on CT scan

          -  Stage IIIb patients must have N3 or T4 status. N3 status must be documented by one of
             the following criteria:

          -  Contralateral (to the primary tumor) mediastinal lymph node, supraclavicular or
             scalene lymph nodes proven by biopsy, FDG-PET scan imaging, or by CT if nodes are > 2
             cm on CT scan.

          -  Patients with positive supraclavicular or scalene lymph nodes must not have disease
             extending up into the cervical region.

          -  All patients must have measurable or evaluable disease documented by CT, MRI, X-ray or
             physical exam within 28 days prior to study treatment.

          -  Negative pregnancy test

        Eligibility for Consolidation Therapy

          -  Following completion of induction chemoradiotherapy patients without local progression
             of disease or distant metastases will then be randomized to receive consolidation
             therapy with docetaxel or observation. Patients will be stratified and randomized
             based on stage IIIa vs IIIb disease at baseline, CR vs. non-CR following induction
             chemoradiation, and ECOG PS 0 or 1 vs. 2.

          -  Patients must have completed chemoradiotherapy per protocol and at least 4 weeks but
             no more than 8 weeks must have elapsed from the last day of induction therapy (the
             last day of radiation) to be eligible for randomization to consolidation with
             docetaxel or observation.

          -  Patients must have undergone re-staging tests according to the study calendar and
             determined to have no evidence of disease progression to be eligible for randomization
             to consolidation with docetaxel or observation.

          -  Patients must have an ANC > 1,500/mm3, platelet count > 100,000/ mm3, and hemoglobin >
             8 g/dl obtained within 14 days prior to registration for randomization to
             consolidation with docetaxel or observation.

          -  Patients must have adequate hepatic function as defined by a serum bilirubin <
             institutional upper limit of normal (ULN) and an AST and/or ALT < 2.5 X the upper
             limits of normal if alkaline phosphatase is < ULN, or alkaline phosphatase may be up
             to 4 X ULN if transaminases are < ULN within 14 days prior to registration for
             randomization to consolidation with docetaxel or observation.

        Exclusion Criteria:

          -  No prior chemotherapy or radiotherapy for lung cancer.

          -  No unintended weight loss > 5% body weight in the preceding 3 months prior to study
             treatment will not be eligible for this trial.

          -  No symptomatic peripheral neuropathy prior to entry onto the study. Peripheral
             neuropathy must be < Grade 1 to be eligible.

          -  No prior malignancy except for adequately treated basal cell or squamous cell skin
             cancer, in situ cervical cancer, or other cancer for which the patient has been
             disease-free for 5 years.

          -  No history of allergic reactions to drugs utilizing the vehicle polysorbate 80
             (docetaxel) and polysorbate 80 + polyethylene glycol (etoposide).

          -  If the patient has hearing loss at pre-study, performance of an audiogram is
             recommended (not mandatory) to document baseline hearing status in the event of
             possible further hearing loss due to cisplatin administration.

          -  No current breastfeeding