Chemotherapy and Radiation in Treating Patients With Stage 3 Non-Small Cell Lung Cancer (PROCLAIM)
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0001060
- Lead Sponsor
- Eli Lilly Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 15
[1] Present with histologically proven or cytological diagnosis of NSCLC that is
defined as other than predominantly squamous cell histology (squamous cell
and/or mixed small cell, non-small cell histology is not permitted)
[2] Stage IIIA or IIIB NSCLC (without malignant pleural/pericardial effusion).
The presence of pleural/pericardial fluid is presumed indicative of metastatic
disease unless proven otherwise.
NOTE: A pleural effusion fluid that is present on both a CT chest scan and
routine chest x-ray requires a pleuracentesis to ensure the effusion is
cytologically negative. Patients with effusions that are exudates are excluded
even if the effusions are cytologically negative. Patients with effusions that
are not visible on routine chest x-ray or are too small to be tapped safely may
be entered on this study, provided the remaining inclusion/exclusion criteria
are met.
Sites are encouraged to obtain tissue confirmation of mediastinal nodal
involvement. However, mediastinal nodal involvement can be declared
present in situations where there is a mass of lymph nodes present in which
the margins of these nodes are indistinct. In situations where the nodes have
distinct margins, the size of the shortest axis of at least 1 node must be
>=2.0 cm (CT/MRI). Cases in which the distinct nodes all have short axis of
<2.0 cm must have pathologic confirmation of disease presence for patients to
be declared eligible.
Patients with Stage IIIB NSCLC who have supraclavicular nodal involvement
may be entered into this study. However, patients with cervical nodes are not
permitted. The upper border of supraclavicular nodes must not extend above
the upper border of the lateral end of the clavicle, extended medially.
[3] Have an ECOG performance status score of 0 or 1
[4] Have tumor lesion measurable according to Response Evaluation Criteria in
Solid Tumors (RECIST; Therasse et al. 2000) or evaluable disease on CT
scan. PET scans and ultrasounds should not be used for lesion measurements
[5] Have adequate pulmonary function defined as a forced expiratory volume in
1 second (FEV1) >50% of predicted normal volume and the carbon monoxide
lung diffusing capacity (DLCO) >40% of predicted normal value. Patients for
whom DLCO measurements are not available will be deemed to have
adequate oxygen transfer if their resting capillary/arterial blood gas on room
air reveals an oxygen pressure (pO2) >60 mmHg.
[6] Have normal organ and marrow function, including the following:
Bone marrow reserve: leukocytes >=3.0 x 109/L, absolute neutrophil count
>=1.5 x 109/L, platelets >=100 x 109/L, and hemoglobin >=9 g/dL
Hepatic: total bilirubin <=1.5 times the upper limit of normal (ULN), liver
transaminases: alkaline phosphatase (AP), aspartate transaminase (AST or
SGOT), and alanine transaminase (ALT or SGPT) <=1.5 times ULN.
Patients with liver transaminases between 1 and 1.5 ULN must have no
indication of liver metastases on contrast-enhanced CT scan
Renal: creatinine <=1.5 times ULN, and calculated creatinine clearance
>=45mL/min, based on the Cockcroft-Gault formula (Cockcroft and Gault
1976)
[7] Weight loss <=10% in the preceding 3 months
[8] Estimated life expectancy >12 weeks
[9] Age >=18 years
[10] Signed informed consent from the patient
[11] For women: must be surgically sterile, postmenopausal, or compliant with a
medically approved contraceptive regimen (for example, intrauterine device
[IUD], birth control pills, or barrier device) during and for 6 months after
[13] Have uncontrolled intercurrent illness including, but not limited to, ongoing or
active infection or psychiatric illness/social situations that would limit
compliance with study requirements
[14] Have myocardial infarction within the preceding 6 months or symptomatic
congestive heart failure, unstable angina pectoris, or uncontrolled cardiac
arrhythmia
[15] Have received treatment within the last 30 days with any other investigational
agents that have not received regulatory approval for any indication at the
time of study enrollment
[16] Have disease considered for surgical treatment as part of their care plan, such
as Pancoast or superior sulcus tumors
[17] Had prior thoracic radiation. However, other prior radiotherapy is allowed.
Patients must have recovered from the toxic effects of the treatment prior to
study enrollment. Patients may not have received whole pelvis radiation or
radiation to more than 25% of their bone marrow (Cristy and Eckermann
1987)
Prior radiotherapy must have been completed at least 30 days prior to study
treatment
[18] Patients whose radiation treatment plans are likely to encompass a volume of
whole lung receiving >=20 Gy in total (V20) of more than 35% of lung volume.
In some circumstances the V20 can exceed 35% (see Section 5.2.1.1.6.7)
[19] Concurrent cancer from another primary site requiring treatment of any kind
within the past 5 years. Exemptions to this will be permitted on a case-bycase
basis after prior approval by the lead Lilly physician or designate if the
investigator believes the patient’s risk of recurrence and death is very low.
Curatively treated nonmelanoma skin cancer or in situ carcinoma of any
origin is allowed. Patients with recurrence of a previously resected lung
cancer or who have a second primary lung cancer are ineligible.
[20] Are pregnant, breast feeding, or unwilling to use adequate contraception
[21] Patients with immune deficiency (for example, HIV positive)
[22] Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs
(NSAIDs), other than an aspirin dose <=1.3 grams per day, for at least 2 days
(5 days for long-acting agents [for example, piroxicam]) before, during, and
for at least 2 days after administration of pemetrexed
[23] Are unable/unwilling to take folic acid, vitamin B12, and dexamethasone
[24] Have recent contraindication or rejection of the use of corticosteroids, or
concomitant yellow fever vaccination (within 30 days of study enrollment)
[25] Have evidence of clinical hearing loss. Patients who have hearing loss based
solely on conduction deficits demonstrated on audiogram may be entered into
the study.
[26] Known hypersensitivity to pemetrexed, cisplatin, etoposide or any of the
excipients in these medicinal products
[27] Had prior systemic chemotherapy for lung cancer.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival
- Secondary Outcome Measures
Name Time Method Progression-free survival