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Non-squamous Nonsmall Cell Neoplasm of LungPhase 3ERACLENCT01303926

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

A Phase 3 study testing cisplatin pemetrexed and carboplatin paclitaxel bevacizumab in people with Non-squamous Nonsmall Cell Neoplasm of Lung, run by Gruppo Oncologico Italia Meridionale at 12 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
cisplatin pemetrexed and carboplatin paclitaxel bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
12 sitesItaly
Study dates
Jan 2010to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 20Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Italy12 sites

  • "Giovanni Paolo II" Oncology Institute

    Bari, BA, 70124

  • "San Paolo Hospital" Oncology Service

    Bari, BA

  • Division of Medical Oncology, "Fatebenefratelli" Hospital

    Benevento, BN

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

    Brindisi, BR, 72100

  • Division of Medical Oncology, Castellaneta Hospital

    Castellaneta, TA

  • Medical Oncology Division "Vito Fazzi" Hospital

    Lecce, Le

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

    Mirano, VE

  • National Cancer Institute "G. Pascale" Thoracic Dept.

    Naples

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

    Palermo, PA

  • Division of Medical Oncology, "La Maddalena" Hospital

    Palermo, PA

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

    San Giovanni Rotondo, FG

  • Division of Medical Oncology "San Giuseppe Moscati Hospital"

    Taranto, TA

Other trials in Italy

About this study

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

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.

Read the 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%)]
Being tested
cisplatin pemetrexed, carboplatin paclitaxel bevacizumab
Keywords
QoL, EQ5D score, cisplatin pemetrexed, carboplatin paclitaxel bevacizumab, maintenance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatin pemetrexedDrug

    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 bevacizumabDrug

    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

Study groups in NCT01303926
Study groupRoleWhat they receive
Cisplatin and PemetrexedActive comparatorNot described
Receives: Drug: cisplatin pemetrexed
Carboplatin paclitaxel bevacizumabActive comparatorNot described
Receives: Drug: carboplatin paclitaxel bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in terms of quality of life (QOL) between treatment arms

    Measured: Treatment efficacy will be evaluated at baseline and every 3 cycles during chemo period and every two months during the maintenance phase

Secondary outcomes (3)

  1. treatment activity in terms of response rate

    Measured: Two year

  2. toxicity evaluation

    Measured: Two years

  3. Evaluation of QoL across time

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2011 (estimated)
  2. Study startJan 2010
  3. Primary completionJun 2012 (estimated)
  4. Study completionJun 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01303926
Sponsor's protocol ID
Goim 2903
Other IDs
2009-015807-19, 2009
Acronym
ERACLE
Status last verified
Apr 2012
First submitted
13 Jan 2011
Last updated
10 Apr 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25582493

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin pemetrexed and carboplatin paclitaxel bevacizumab in people with Non-squamous Nonsmall Cell Neoplasm of Lung, run by Gruppo Oncologico Italia Meridionale at 12 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01303926, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2012.

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