Study in patients suffering from lung cancer to compare different treatment programmes.

Phase 1

• Conditions: Patients with completely resected Stage II-IIIA non-small cell lung cancer (NSCLC).; MedDRA version: 19.0Level: LLTClassification code 10025053Term: Lung cancer non-small cell stage IIIASystem Organ Class: 100000004864; MedDRA version: 19.0Level: LLTClassification code 10025051Term: Lung cancer non-small cell stage IISystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2008-001764-36-DE
• Lead Sponsor: niversity of Turin, Dept of Clinical & Biological Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-02
• Last Update Posted: 5 December 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 770

Inclusion Criteria

1. All patients must have histological evidence of pathological stage II-IIIA NSCLC after radical surgery. Accepted types of resection are lobectomy, bilobectomy, sleeve
lobectomy and pneumonectomy. Staging criteria follow the currently used TNM
International Staging System (7th edition UICC, 2010). Complete mediastinal lymph node resection or sampling is required. The tissue must be adequate for the pharmacogenomic analysis.
2. All surgical margins of resection must be negative for tumor (R0).
3. Patients must be 18 years of age or older.
4. Patients must have a ECOG Performance Status of 0 - 1 (see appendix B).
5. Patients must not have received any prior systemic chemotherapy or radiation therapy prior to resection of lung cancer. Chemotherapy or radiotherapy for cancer more than 5 years prior to enrollment is allowed.
6. Patients must not receive any other investigational therapy during the adjuvant treatment and any other investigational therapy must be stopped at least 6 months before the inclusion in this protocol.
7. An interval of minimum 45 to maximum 60 days must have been elapsed between surgery and the start of adjuvant therapy.
8. Patients must have an absolute granulocyte count or absolute neutrophil count = 2,000/µl, platelet count = 100,000/µl and WBC = 4,000/µl obtained within 14 days before starting adjuvant treatment.
9. Patients must have a serum creatinine =1.5 x upper limit normal AND calculated
creatinine clearance =45 ml/min using the following formula: Estimated Creatinine
Clearance (ml/min) = (140 - age) x WT (kg)/72 x creatinine (mg/dl) x 0.85 if female.
These tests must have been obtained within 14 days before starting adjuvant treatment.
10. All patients must sign and give written informed consent in accordance with local laws, ICH-GCP requirements and institutional regulations.
11. Patients must be accessible for treatment and follow up.
12. Compliant with an effective contraceptive method during and for 6 months after the end of treatment (for women and men). An effective contraceptive method is defined as hormonal contraception or intrauterine device or double barrier method (diaphragm in conjunction with spermicide or condom in conjunction with spermicide).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220

Exclusion Criteria

Patients will be excluded from the study if any of the following criteria are met at Screening:

1. Patients with serious infections at the time of randomization or other serious underlying medical conditions, which would impair the ability of the patient to receive the protocol treatment.
2. Pregnant or nursing women. Women of reproductive potential must not participate unless they use an effective contraceptive method and they have provided a negative serum or urine pregnancy test at screening visit. An effective contraceptive method is defined as hormonal contraception or intrauterine device or double barrier method (diaphragm in conjunction with spermicide or condom in conjunction with spermicide).
3. Any prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for at least five years prior to enrollment.
4. Peripheral neuropathy > CTC Grade 1.
5. Have had recent (within 30 days of study treatment) or concurrent yellow fever vaccination
6. Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV (Appendix C)
7. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents, other than an aspirin dose =1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
8. Inability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids.
9. History of severe hypersensitivity reactions to products containing cremophor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified