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

NCT01303926 | Unknown Phase 3 DMC

• 2 other identifiers: Goim 29032009-015807-19
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 12

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.

Conditions

Non-squamous Nonsmall Cell Neoplasm of Lung

Keywords

QoL; EQ5D score; cisplatin pemetrexed; carboplatin paclitaxel bevacizumab; maintenance

Outcome Measures

Primary Outcomes (1)

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

  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)

• treatment activity in terms of response rate

  Two year

• toxicity evaluation

  Two years

• Evaluation of QoL across time

  Two years

Study Arms (2)

Cisplatin and Pemetrexed

ACTIVE COMPARATOR

Drug: cisplatin pemetrexed

Carboplatin paclitaxel bevacizumab

ACTIVE COMPARATOR

Drug: carboplatin paclitaxel bevacizumab

Interventions

cisplatin pemetrexed 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

Cisplatin and Pemetrexed

carboplatin paclitaxel bevacizumab 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

Carboplatin paclitaxel bevacizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gruppo Oncologico Italia Meridionale: lead

Study Sites (12)

"Giovanni Paolo II" Oncology Institute

Bari, BA, 70124, Italy

Location

"San Paolo Hospital" Oncology Service

Bari, BA, Italy

Location

Division of Medical Oncology, "Fatebenefratelli" Hospital

Benevento, BN, Italy

Location

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

Brindisi, BR, 72100, Italy

Location

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

San Giovanni Rotondo, FG, Italy

Location

Medical Oncology Division "Vito Fazzi" Hospital

Lecce, Le, Italy

Location

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

Palermo, PA, Italy

Location

Division of Medical Oncology, "La Maddalena" Hospital

Palermo, PA, Italy

Location

Division of Medical Oncology, Castellaneta Hospital

Castellaneta, TA, Italy

Location

Division of Medical Oncology "San Giuseppe Moscati Hospital"

Taranto, TA, Italy

Location

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

Mirano, VE, Italy

Location

National Cancer Institute "G. Pascale" Thoracic Dept.

Napoli, Italy

Location

Related Publications (1)

• 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.

  PMID: 25582493 DERIVED

Study Officials

• Giuseppe Colucci, MD

  Oncology Institute of Bari

  PRINCIPAL INVESTIGATOR

• Domenico Galetta, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: February 25, 2011
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 10, 2012

Record last verified: 2012-04

Locations

IT (12)