Treating NSCLC Minimal Stage IV With Curative Intent
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|ClinicalTrials.gov Identifier: NCT02054819|
Recruitment Status : Terminated (Didn't meet accrual goal, change in standard of care.)
First Posted : February 4, 2014
Last Update Posted : August 21, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Other: Induction chemotherapy and concurrent radiation Other: Consolidation: Radiation therapy to metastatic sites||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Treating Patients With Minimal Stage IV Non-Small Cell Lung Cancer (NSCLC) With Curative Intent|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||August 22, 2017|
|Actual Study Completion Date :||August 22, 2017|
Single arm study
Induction chemotherapy and concurrent radiation to primary tumor Cycle 1: irinotecan 65mg/m2 and cisplatin 30 mg/m2 on Day 1 and 8 Q 21 days Cycles 2-4: irinotecan 65 mg/m2, and cisplatin 30 mg/m2 Day 1 and 8 Q 21 days PLUS radiation therapy 66 Gy/7weeks/33 daily fractions
Consolidation Radiation: therapy to metastatic sites At least 60 Gy total (taking into account a possible 3 Gy x 4 pre-treatment or equivalent) to all metastatic sites.
Other: Induction chemotherapy and concurrent radiation
Cycle 1: irinotecan 65mg/m2 and cisplatin 30 mg/m2 on Day 1 and 8 Q 21 days Cycles 2-4: irinotecan 65 mg/m2, and cisplatin 30 mg/m2 Day 1 and 8 Q 21 days PLUS radiation therapy 66 Gy/7weeks/33 daily fractions
Other: Consolidation: Radiation therapy to metastatic sites
At least 60 Gy total (taking into account a possible 3 Gy x 4 pre-treatment or equivalent) to all metastatic sites. For brain, 2.5 Gy x 14 to whole brain to follow stereotactic radiosurgery (SRS).
- Overall survival [ Time Frame: Anticipated medial survival time is 8 - 10 months, however, all participants will be followed until death, assessed up to 100 months. ]Measure time of survival from enrollment to death from any cause, assessed up to 100 months.
- New metastatic disease [ Time Frame: Anticipated time to progression is unknown, however, all patients will be followed for survival, up to 100 months. ]Measure of time from patient entry to time of new disease or progression of disease or date of death from any cause, whichever came first, assessed up to 100 months.
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Histological or cytological documented NSCLC, including squamous cell carcinoma, adenocarcinoma, large cell carcinoma including large cell neuroendocrine carcinoma and poorly differentiated (not otherwise specified - NOS) non-small cell lung cancer. Bronchial alveolar adenocarcinoma and totally resected tumors are excluded. All histology is to be reviewed at East Carolina University or designated participating center.
- Patients with Stage II-IIIB intra-thoracic disease with oligometastatic disease (hereafter referred to as "Stage IVa" disease) are eligible. Definition of Stage IVa:
Metastatic disease; either biopsy proven or with strong radiographic evidence suggesting its existence.
As determined by CT, MRI or PET no more than five distinct metastatic sites. All metastatic disease must be anatomically located in such a way as to permit a reasonable attempt at permanent ablation. Ablative measures may include surgery, stereotactic radiosurgery, and external beam therapy. Patients who meet the minimal metastatic disease requirement and who would otherwise have been staged II, IIIA or IIIB.
- Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field.
- Patients must be ≥ 18 years of age.
- Patients with Zubrod (ECOG) performance status ≤ 2.
- Adequate hematologic function defined as: absolute neutrophil count (ANC) ≥ 1000/mm3, platelets ≥ 75,000/mm3, and hemoglobin ≥ 8 g/dL (prior to transfusions); adequate hepatic function defined as: total bilirubin ≤ 3.0 mg/dl, and adequate renal function defined as a serum creatinine level ≤ 2.0 mg/dl.
- Forced expiratory volume (FEV1) ≥ 800ml.
- Patients with weight loss < 20% over the past 3 months.
- Patients with a pleural effusion that is proven cytologically negative or is too small to tap.
- Women of childbearing potential must agree to practice effective contraception throughout the study plus four weeks.
- Pretreatment evaluations required for eligibility include:
A medical history, physical exam, and Zubrod performance status within 3 weeks prior to study entry.
Complete blodd count (CBC) with differential and platelet count, and laboratory profile must be completed within 3 weeks prior to study entry.
FEV1, CT scan of the chest or whole body PET (preferred), and a CT scan or MRI (preferred) of the brain within 4 weeks prior to study entry.
For women of childbearing potential, a serum or urine pregnancy test within a week prior to the start of protocol treatment.
Medical Oncology and Radiation Oncology consultation and approval.
- Patients must sign a study-specific consent form prior to study entry.
- Prior systemic chemotherapy or radiotherapy that would interfere with delivery of treatment as outlined above as judged by the clinician.
- Cytologically malignant effusions.
- Metastatic disease beyond what is described in section 3.1.2.
- Active pulmonary infection not responsive to antimicrobial therapy.
- History of symptomatic interstitial pneumonitis.
- Significant symptomatic cardiac disease, i.e., unstable angina, uncompensated congestive heart failure, or uncontrolled cardiac ventricular arrhythmias.
- Patients with > grade 2 neuropathy.
- Evidence of malignancy in the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers.
- Women who are pregnant or breast feeding.
- Women of childbearing potential who are unwilling to practice effective contraception.
- Patients who currently are participating in other clinical trials and/or who have participated in other clinical trials in the previous 30 days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054819
|United States, North Carolina|
|Leo W. Jenkins Cancer Center|
|Greenville, North Carolina, United States, 27834|
|Principal Investigator:||Paul Walker, MD, PhD||Brody School of Medicine ar East Carolina University|
|Responsible Party:||Leo W. Jenkins Cancer Center|
|Other Study ID Numbers:||
|First Posted:||February 4, 2014 Key Record Dates|
|Last Update Posted:||August 21, 2019|
|Last Verified:||March 2018|
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases