Induction Chemotherapy Followed by CCRT According to EGFR Mutation Status in NSCLC III

NCT00620269 | Unknown Phase 2 DMC

• 1 other identifier: NCCCTS-07-255
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

The use of induction chemotherapy is feasible and effective. It is also logistically beneficial for decreasing micrometastases and radiation-related toxicity by decreasing tumor burden before definite locoregional concurrent therapy. Previously the investigators conducted several phase II study of IP chemotherapy in advanced NSCLC and demonstrated that IP chemotherapy has a promising activity and readily manageable toxicity profile. Given the encouraging activity of IP chemotherapy in the advanced stage setting, the investigators postulated that their further investigation in the stage III setting might lead to further prolongation of survival times. In addition to cisplatin, Irinotecan has been demonstrated to act as radiation sensitizers in preclinical and clinical setting. Therefore, their use with concurrent radiotherapy might lead to radiation sensitization and improved locoregional control.

Conditions

Lung Cancer; NSCLC

Keywords

NSCLC; EGFR mutation; Erlotinib; IP chemotherapy; CCRT

Outcome Measures

Primary Outcomes (1)

• Response rate

  every 8 weeks

Secondary Outcomes (4)

• Time to progression

  evey 8 weeks

• Patient's Quality of life(QOL)

  Quality of life is assessed by EORTC-QLQ (C-30 and LC13) questionnaire at baseline, after induction chemotherapy, after 10 weeks and 19 weeks CCRT will be finished

• Toxicity

  every 3 weeks

• Overall Survival

  every 8 weeks

Study Arms (4)

study arm 1

EXPERIMENTAL

Induction (with Erlotinib X 3 cycles) -\> CCRT with Erlotinib (X 2 cycles) -\> continue Erlotinib (X 6 cycles)

Drug: Erlotinib; Radiation: CCRT

study arm 3

EXPERIMENTAL

Induction (IP X 3 cycles) -\> CCRT with IP (X 2 cycles)

Drug: Induction or consolidation IP chemotherapy; Drug: CCRT with IP chemotherapy (Irinotecan + Cisplatin); Radiation: CCRT

control arm

ACTIVE COMPARATOR

CCRT with IP (X 2 cycles) -\> consolidation IP (X 3 cycles)

Drug: Induction or consolidation IP chemotherapy; Drug: CCRT with IP chemotherapy (Irinotecan + Cisplatin); Radiation: CCRT

study arm 2

EXPERIMENTAL

Induction (Erlotinib X 3 cycles) -\> CCRT with IP (X 2 cycles) -\> recurrence -\> Erlotinib (until PD)

Drug: Erlotinib; Drug: CCRT with IP chemotherapy (Irinotecan + Cisplatin); Radiation: CCRT

Interventions

Erlotinib DRUG

Erlotinib 150 mg p.o. daily x21 days every 3 weeks

study arm 1; study arm 2

Induction or consolidation IP chemotherapy DRUG

Irinotecan 65mg/m2 + Cisplatin 30mg/m2 IV on D1,D8 every 3 weeks X 3 cycles

control arm; study arm 3

CCRT with IP chemotherapy (Irinotecan + Cisplatin) DRUG

Irinotecan (60mg/m2) + cisplatin (30mg/m2) IV on D1 \& 8 every 3 weeks X 2 cycles

control arm; study arm 2; study arm 3

CCRT RADIATION

CCRT :Concurrent Thoracic Radiotherapy (2.4 Gy/fr, Total 60 Gy, 25fr over 5 weeks)

control arm; study arm 1; study arm 2; study arm 3

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed NSCLC: it is recommended to obtain adequate tissue samples for EGFR mutation analysis.
• Unresectable stage IIIA (N2) or stage IIIB NSCLC defined as:unresectability confirmed by Surgeon /Stage IIIa T1-3 N2/Stage IIIb T1-4 N3/Stage IIIb T4 N2
• Age 18 years over.
• ECOG performance status of 0 or 1.
• Tumor work-up: within 4 weeks prior 1st day of treatment: chest X-ray; CT of chest, liver, and adrenal glands; bone scan; brain MRI
• Measurable or un-measurable disease (according to RECIST criteria), documented by CT, MRI, X-ray, or physical exam, as appropriate.
• Hematology (within 1 week before 1st day of treatment)Absolute Neutrophil Count ³2.0 x 109/L; Platelet ³100 x 109/L; Hemoglobin ³10 g/dl
• Liver function test (within 1 week before 1st day of treatment)Serum bilirubin £1 x UNL; AST \& ALT £2.5 x UNL
• Renal function (within 1 week before 1st day of treatment)Serum creatinine £1 x UNL. In case of borderline value, 24h creatinine clearance should be \> 60 mL/min.
• Pulmonary function (within 4 weeks before 1st day of treatment)FEV1 ³ 1 Liter
• ECG without significant abnormalities within 4 weeks before 1st day of treatment.
• Written informed consent.

You may not qualify if:

• T4 with malignant pleural effusion.
• Any prior therapy (chemotherapy, immunotherapy, biologic therapy such as EGFR-targeted therapy, radiotherapy) for lung cancer.
• History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
• Unintended weight loss \> 10% within the last 3 months.
• Other serious concomitant illness or medical conditions:
• Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia.
• History of significant neurological or psychiatric disorders including dementia or seizures.
• Active infection requiring IV antibiotics.
• Active ulcer, unstable diabetes mellitus or other contra-indication of corticosteroid therapy.
• Significant gastrointestinal abnormalities, including requirement for intravenous nutrition, active peptic ulcer disease, prior surgical procedures affecting absorption.
• Pregnant or lactating women-Patients (male or female) with reproductive potential not implementing adequate contraceptive measures.
• Concurrent treatment with any other experimental anti-cancer drugs.
• Concurrent use of phenytoin, carbamazepin, barbiturates, or rifampin.
• Mental condition rendering the patient unable to understand the nature, scope, and possible consequence of the study.
• Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, and not likely to complete the study.

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Roche Pharma AG: collaborator
• Pfizer: collaborator

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyenggi-do, 411-769, South Korea

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Erlotinib Hydrochloride; Neoadjuvant Therapy; Irinotecan; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Camptothecin; Alkaloids; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jin Soo Lee, M.D.

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung JIn Yoon, Rn

CONTACT

+82-31-920-0405; jinijiniya@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 7, 2011

Record last verified: 2011-11

Locations

KR (1)