RPCEC00000207Not yet recruitingPhase 2
Open randomized controlled clinical trial in patients with non-small cell lung cancer, stage IB, II and IIIA, treated or not with VAXIRA®, after surgery and adjuvant cisplatin-based chemotherapy
ational Institute of Oncology and Radiobiology (INOR)0 sites120 target enrollmentStarted: December 15, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled trial. Masking: Open. Control group: No intervention. Assignment: Parallel. Purpose: Treatment
Eligibility Criteria
- Ages
- 18 years to one (—)
- Sex
- All
Inclusion Criteria
- •1-Male and female patients = 18 years with tumors in non-small cell lung and pathologically proven completely resected stage IB, II or IIIA stages.
- •2-Patients who have signed informed consent for research.
- •3-Patients where surgical technique for tumor resection patient has been anatomical, involving at least a lobectomy .
- •4-Patients in the mediastinal lymph node sampling has been carried out by radical mediastinal lymphadenectomy corresponding compartment.
- •5-Disease-free patients (locoregional metastases or relapse), confirmed by a negative CT study at baseline chest CT scan, upper abdomen and brain CT or MRI.
- •6-Patients with performance status 0-2 according to ECOG scale.
- •7-Patients who received adjuvant chemotherapy after surgery, have been completed or not all cycles.
- •8-Patients who have then received adjuvant chemotherapy, radiotherapy treatment option in accordance with pN.
- •9-Patients in the time between the end of oncospecific treatment and inclusion in the study does not exceed 2 months.
- •10-Patients with hepatic, renal and haematological normal functions defined by:
- •-Hemoglobina >= 10 g / L
- •Leukocyte - Total count >= 3.0 x 109 / L
- •Absolute Neutrophil -Count >= 1.5 x 109 / L
- •Platelet -Count >=100 x 109 / L
- •-Bilirubin To the upper limit of normal.
- •-TGP And TGO: up 1.5 times the upper limit of normal value of the institution, or <5 times the upper limit of normal value of the institution, if known the existence of liver metastases.
- •-Fosfatasa Alkaline =< 2.5 times the ULN.
- •-Creatinina: Within normal limits or creatinine clearance> 50 mL / min / 1.73 m2 for patients with creatinine levels above the normal value of the institution.
Exclusion Criteria
- •1- Stage IIIA patients who received neoadjuvant chemotherapy before surgery.
- •2- Patients whose primary tumor was removed by segmentectomy or wedge resection.
- •3- Patients showing any microscopic evidence of residual tumor after surgery (positive BSQ).
- •4- Patients who have previously received treatment with VAXIRA® vaccine or other immunotherapy.
- •5- Patients with previous history of cancer, except nonmelanoma skin tumors or carcinoma in situ of the cervix treated properly.
- •6- Patients with acute infectious diseases, chronic inflammatory or unbalanced.
- •7- Patients of childbearing age who do not accept use appropriate contraception (intrauterine devices, barrier methods or tubal ligation, hormonal methods).
- •8- Patients pregnant or breastfeeding.
- •9- Patients with acute allergic conditions or history of severe allergic reactions.
- •10- Patients who have received organ grafts.
- •11- Patients with psychiatric illness or addiction problems that may compromise their ability to give informed consent or to comply with trial procedures.
Investigators
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