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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Gruppo Oncologico Italia Meridionale.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Giuseppe Colucci MD, Gruppo Oncologico Italia Meridionale
ClinicalTrials.gov Identifier:
NCT01303926
First received: January 13, 2011
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Non-squamous Nonsmall Cell Neoplasm of Lung
Drug: cisplatin pemetrexed
Drug: carboplatin paclitaxel bevacizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction Pemetrexed and Cisplatin Followed by Pemetrexed as Maintenance vs Carboplatin-paclitaxel and Bevacizumab Followed by Bevacizumab as Maintenance:Multicenter Randomized Phase III Study in Patients With Advanced Non-Squamous Non Small-cell Lung Cancer: a Quality of Life Oriented Phase III Trial of the GOIM

Resource links provided by NLM:


Further study details as provided by Gruppo Oncologico Italia Meridionale:

Primary Outcome Measures:
  • Difference in terms of quality of life (QOL) between treatment arms [ Time Frame: Treatment efficacy will be evaluated at baseline and every 3 cycles during chemo period and every two months during the maintenance phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • treatment activity in terms of response rate [ Time Frame: Two year ] [ Designated as safety issue: Yes ]
  • toxicity evaluation [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • Evaluation of QoL across time [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 118
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cisplatin and Pemetrexed Drug: 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
Active Comparator: Carboplatin paclitaxel bevacizumab 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

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%)]
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303926

Locations
Italy
"Giovanni Paolo II" Oncology Institute
Bari, BA, Italy, 70124
"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, 72100
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, "La Maddalena" Hospital
Palermo, PA, Italy
Division of Medical Oncology, "Buccheri-La Ferla" 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
Sponsors and Collaborators
Gruppo Oncologico Italia Meridionale
Investigators
Principal Investigator: Giuseppe Colucci, MD Oncology Institute of Bari
Study Director: Domenico Galetta, MD "Giovanni Paolo II" Oncology Instutute Medical Oncology Dept. Bari (Italy)
  More Information

Additional Information:
No publications provided

Responsible Party: Giuseppe Colucci MD, President, Gruppo Oncologico Italia Meridionale
ClinicalTrials.gov Identifier: NCT01303926     History of Changes
Other Study ID Numbers: Goim 2903, 2009-015807-19
Study First Received: January 13, 2011
Last Updated: April 9, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Gruppo Oncologico Italia Meridionale:
QoL
EQ5D score
cisplatin pemetrexed
carboplatin paclitaxel bevacizumab
maintenance

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Bevacizumab
Cisplatin
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014