Quality of Life Comparison in Advanced Non-squamous Non Small Cell Lung Cancer

NCT ID: NCT01303926

Last Updated: 2012-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-06-30

Brief Summary

Cisplatin and pemetrexed combination or carboplatin, paclitaxel and bevacizumab are now considered as standard treatment in non-squamous cell lung carcinoma (NSCLC). Both main registrative trials are considered positive because they reached their objectives, but within them, the Quality of Life (QoL) of patients was not detailed neither has represented as primary objective of the studies. It is considered that, together with enhancements that are added to the knowledge of the biology of NSCLC, QoL may influence the therapeutic choice if one of the associations show to be better tolerated by the patient and favours an amelioration of his QoL.

Detailed Description

The study aims primarily to verify the null hypothesis that between the two schemes under consideration there is no minimal interesting difference (MID) (i.e. a difference of clinical interest) after initial 3 months of maintenance.EuroQ5D (EQ5D) questionnaire total score and EQ5D visual analog scale (VAS)are validated and very simple to be administered.The statistical hypothesis tests described above are performed with t-test for unpaired data (or equivalent non-parametric, pending verification of normality of distribution by Shapiro-Wilk test), with alpha error = 0.05 (2-sided). It is assumed that:

1. about 20% of randomized patients experienced a progression of disease before the time of evaluation of the primary endpoint, and that

2. this eventuality was not significantly different between the two treatments. The total sample to be enrolled for this study will then be increased to 118 patients [(49 +49) +20%)]

Conditions

Non-squamous Nonsmall Cell Neoplasm of Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cisplatin and Pemetrexed

Group Type: ACTIVE_COMPARATOR

cisplatin pemetrexed

Intervention Type: DRUG

Cisplatin 75 mg / m2 d1 with Pemetrexed 500 mg / m2 d1 every 3 weeks for 6 cycles followed (in responding or stable patients) by Pemetrexed 500 mg / m2 every 3 weeks, until progression or unacceptable toxicity

Carboplatin paclitaxel bevacizumab

Group Type: ACTIVE_COMPARATOR

carboplatin paclitaxel bevacizumab

Intervention Type: DRUG

Carboplatin AUC 6 d1 plus Paclitaxel 200 mg/m2 d1 and Bevacizumab 15 mg/kg every 3 weeks for 6 cycles followed in stable or responding patients by Bevacizumab 15 mg/kg every 3 weeks, until progression or unacceptable toxicity

Interventions

cisplatin pemetrexed

Cisplatin 75 mg / m2 d1 with Pemetrexed 500 mg / m2 d1 every 3 weeks for 6 cycles followed (in responding or stable patients) by Pemetrexed 500 mg / m2 every 3 weeks, until progression or unacceptable toxicity

Intervention Type: DRUG

carboplatin paclitaxel bevacizumab

Carboplatin AUC 6 d1 plus Paclitaxel 200 mg/m2 d1 and Bevacizumab 15 mg/kg every 3 weeks for 6 cycles followed in stable or responding patients by Bevacizumab 15 mg/kg every 3 weeks, until progression or unacceptable toxicity

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent(as approved by the local Ethical Committee)
• Histological type consisting mainly of non-squamous histology defined preferably with stage IV metastatic disease or stage IIIB in the presence of supraclavicular lymph nodes according to the parameters of TNM 7th Ed, not amenable to curative therapy
• ECOG PS 0-1
• Adequate bone marrow reserve
• Adequate hepatic, coagulative and renal function

Exclusion Criteria

• Mixed NSCLC tumors or mixed adenosquamous carcinomas with a predominant squamous component histotype (NSCLC and SCLC) or adenosquamous forms, with predominant squamous component
• History of gross hemoptysis <3 months prior to enrollment or history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
• Tumors invading or abutting major blood vessels (based on radiologist assessment)
• Evidence of brain metastases not previously treated with RT (or any loco-regional treatment)
• Prior neoadjuvant or adjuvant chemotherapy within six months prior to study enrollment
• Previous radiotherapy in the last month before study entry (except for radiotherapy to symptomatic bone sites at risk and not covered in the premises of measurable disease and assessable)
• A major surgery (including open biopsy) in the month preceding study enrollment or anticipation of a major surgery during the study
• Unable or unwilling to take folic acid or vitamin B12 supplementation
• Unable or unwilling to take corticosteroids
• History of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis
• Clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
• Need for taking or have recently taken (within 10 days of enrollment) aspirin (>325 mg/d), clopidogrel at doses >75 mg/d, dipyramidole, ticlopidine, or cilostazol. Patients are also excluded if they cannot hold nonsteroidal anti-inflammatory agents, other than prophylactic therapy with low-dose aspirin, for a 5-day period during each cycle (8-day period for long-acting agents, such as piroxicam)
• Need for taking or have recently taken (within 10 days of enrollment) fulldose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes. Prophylactic use of anticoagulants is allowed; international normalized ratio (INR) should be <1.5 at study enrollment
• History of thrombotic disorders within the last 6 months prior to entry History of hypertension, unless hypertension is well controlled study entry (≤150/90 mm Hg) and the patient is on a stable regimen of antihypertensive therapy. Patients should not have any prior history of hypertensive crisis or hypertensive encephalopathy
• 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
• Serious concomitant systemic disorder (for example, active infection including human immunodeficiency virus) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol
• Receiving concurrent administration of any other antitumor therapy
• Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment
• Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score ≤6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously
• Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Oncologico Italia Meridionale

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Colucci MD

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe Colucci, MD

Role: PRINCIPAL_INVESTIGATOR

Oncology Institute of Bari

Domenico Galetta, MD

Role: STUDY_DIRECTOR

"Giovanni Paolo II" Oncology Instutute Medical Oncology Dept. Bari (Italy)

Locations

"Giovanni Paolo II" Oncology Institute

Bari, BA, Italy

"San Paolo Hospital" Oncology Service

Bari, BA, Italy

Division of Medical Oncology, "Fatebenefratelli" Hospital

Benevento, BN, Italy

Division of Medical Oncology, "Sen. Perrino" Hospital, Brindisi, Italy

Brindisi, BR, Italy

7 Division of Medical Oncology, "Casa Sollievo della Sofferenza" Hospital,

San Giovanni Rotondo, FG, Italy

Medical Oncology Division "Vito Fazzi" Hospital

Lecce, Le, Italy

Division of Medical Oncology, "Buccheri-La Ferla" Hospital

Palermo, PA, Italy

Division of Medical Oncology, "La Maddalena" Hospital

Palermo, PA, Italy

Division of Medical Oncology, Castellaneta Hospital

Castellaneta, TA, Italy

Division of Medical Oncology "San Giuseppe Moscati Hospital"

Taranto, TA, Italy

Clinical Trials Office, Department of Medical Sciences, Azienda ULSS 13

Mirano, VE, Italy

National Cancer Institute "G. Pascale" Thoracic Dept.

Napoli, , Italy

Countries

Italy

References

Galetta D, Cinieri S, Pisconti S, Gebbia V, Morabito A, Borsellino N, Maiello E, Febbraro A, Catino A, Rizzo P, Montrone M, Misino A, Logroscino A, Rizzi D, Di Maio M, Colucci G. Cisplatin/Pemetrexed Followed by Maintenance Pemetrexed Versus Carboplatin/Paclitaxel/Bevacizumab Followed by Maintenance Bevacizumab in Advanced Nonsquamous Lung Cancer: The GOIM (Gruppo Oncologico Italia Meridionale) ERACLE Phase III Randomized Trial. Clin Lung Cancer. 2015 Jul;16(4):262-73. doi: 10.1016/j.cllc.2014.12.002. Epub 2014 Dec 9.

Reference Type: DERIVED

PMID: 25582493 (View on PubMed)

Other Identifiers

2009-015807-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Goim 2903

Identifier Type: -

Identifier Source: org_study_id