Multicenter Randomized Controlled Trial Adjuvant Chemotherapy vs Observation in pStage Ib Lung Adenocarcinoma

NCT02281708 | Unknown Phase 3 DMC

• 1 other identifier: CRO
• Study Type: interventional
• Target: 1,012
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers developed the nomogram which evaluate the risk of recurrence after surgical resection, and found that the stage 1 NSCLC patients with more than 104 point of nomogram showed similar recurrence rate to the recurrence rate of stage 2 NSCLC patients. Thus those stage 1 NSCLC patients at high recurrence rate are considered to show positive effect of adjuvant chemotherapy and perform the study to prove this hypothesis. Applying the nomogram, the patient scored lower than 104 is categorized into low risk group and is to be grouped as the observation group which adjuvant chemotherapy will not be given. The high risk group patients (the nomogram scored larger than 104) are randomly divided into the treatment group and the observation group. Then, the clinical result on the recurrence between the observation group and the treatment group will be compared. \- Regimen of the adjuvant chemotherapy: The most commonly used 1st line chemotherapy regimen which is vinorelbine plus cisplatin will be admitted for 4 cycles. Also the three days before and the after the estimated day are permitted as allowance. Intravenous administration of vinorelbine (25mg/m2), the 1st and the 8th day of the each cycle, every 3 weeks. Intravenous administration of cisplatin (75mg/m2), the 1st day of the each cycle, every 3 weeks.

Conditions

Stage Ib Lung Carcinoma

Keywords

normogram; recurrence; adjuvant chemotherapy; disease free survival; Quality of life

Outcome Measures

Primary Outcomes (1)

• disease-free survival (DFS)

  the time between the operation and the date of treatment for recurred lung cancer or suspected recurrence

  3 year

Secondary Outcomes (2)

• overall survival rate (OS)

  3 year, 5 year

• quality-of-life (QoL)

  1 year

Study Arms (3)

low risk

NO INTERVENTION

low risk; observation

high risk; observation group

NO INTERVENTION

high risk: observation

high risk; adjuvant chemotherapy group

EXPERIMENTAL

high risk. vinorelbine plus cisplatin

Drug: vinorelbine plus cisplatin

Interventions

vinorelbine plus cisplatin DRUG

Drugs will be administered for 4 cycles, and should be administered at scheduled day +/- 3 days * vinorelbine 25mg/m2 IV (Day 1, 8) q 3wks cisplatin 75mg/m2 IV (Day 1) q 3wks

Also known as: Navelbine (cisplatin) plus DDP

high risk; adjuvant chemotherapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet ALL of the following criteria in order to be eligible for this study
• Age ≥18 years and Age \<80
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• The pathological stage Ib adenocarcinoma after complete resection (AJCC 7th). (Patients with adenocarcinoma in situ are excluded)
• Patients must have undergone pulmonary resection more than lobectomy (lobectomy, bilobectomy, pneumonectomy).
• Patients must have undergone either mediastinal lymph node dissection or systemic sampling.
• Tumor must be resected completely without gross or microscopic residual tumor.
• The interval between surgery for lung cancer and randomization must be no more than 8 weeks.
• The patients must be willing and sign informed consent prior to randomization.
• Patients with appropriate bone marrow function. ANC ≥1,500/uL, hemoglobin ≥9.0g/dL (can be corrected by transfusion). platelet ≥100,000/uL
• Patients with appropriate renal function Serum creatinine ≤ 1 x UNL(upper limit or normal) or Estimated creatinine clearance ≥ 45 ml/min
• Patients with appropriate liver function Serum bilirubin ≤ 1.5 x UNL, AST (SGOT) and ALT (SGPT) ≤ 3 x UNL, alkaline phosphatase ≤ 3 x UNL

You may not qualify if:

• Patients meeting any ONE of the following criteria are not eligible for this study.
• Other concurrent serious diseases that may interfere with planned treatment.
• Pregnant of lactation women
• Women of childbearing potential without a negative pregnant test (urine HCG), within 14 days prior to randomization or less than one year after menopause.
• Any previous systemic chemotherapy for cancer or anti-cancer immunotherapy.
• History of non-lung malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, melanoma in situ.
• Serious cardiac illness or medical conditions including uncontrolled hypertension, myocardial infarction within 6 months, unstable angina pectoris, heart failure \>NYHA grad II, or uncontrolled arrhythmia.
• Patients with sensitivity to vinorelbine or cisplatin.
• Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (7)

• Hung JJ, Jeng WJ, Chou TY, Hsu WH, Wu KJ, Huang BS, Wu YC. Prognostic value of the new International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society lung adenocarcinoma classification on death and recurrence in completely resected stage I lung adenocarcinoma. Ann Surg. 2013 Dec;258(6):1079-86. doi: 10.1097/SLA.0b013e31828920c0.

  PMID: 23532112 BACKGROUND

• Okada M, Nakayama H, Okumura S, Daisaki H, Adachi S, Yoshimura M, Miyata Y. Multicenter analysis of high-resolution computed tomography and positron emission tomography/computed tomography findings to choose therapeutic strategies for clinical stage IA lung adenocarcinoma. J Thorac Cardiovasc Surg. 2011 Jun;141(6):1384-91. doi: 10.1016/j.jtcvs.2011.02.007. Epub 2011 Mar 25.

  PMID: 21440264 BACKGROUND

• Kim HR, Kim DJ, Lee WW, Jheon S, Sung SW. The significance of maximum standardized uptake values in patients with stage I pulmonary adenocarcinoma. Eur J Cardiothorac Surg. 2009 Apr;35(4):712-6; discussion 716-7. doi: 10.1016/j.ejcts.2008.12.030. Epub 2009 Feb 10.

  PMID: 19211260 BACKGROUND

• Strauss GM, Herndon JE 2nd, Maddaus MA, Johnstone DW, Johnson EA, Harpole DH, Gillenwater HH, Watson DM, Sugarbaker DJ, Schilsky RL, Vokes EE, Green MR. Adjuvant paclitaxel plus carboplatin compared with observation in stage IB non-small-cell lung cancer: CALGB 9633 with the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups. J Clin Oncol. 2008 Nov 1;26(31):5043-51. doi: 10.1200/JCO.2008.16.4855. Epub 2008 Sep 22.

  PMID: 18809614 BACKGROUND

• Cerfolio RJ, Bryant AS, Ohja B, Bartolucci AA. The maximum standardized uptake values on positron emission tomography of a non-small cell lung cancer predict stage, recurrence, and survival. J Thorac Cardiovasc Surg. 2005 Jul;130(1):151-9. doi: 10.1016/j.jtcvs.2004.11.007.

  PMID: 15999056 BACKGROUND

• Ohtsuka T, Nomori H, Watanabe K, Kaji M, Naruke T, Suemasu K, Uno K. Prognostic significance of [(18)F]fluorodeoxyglucose uptake on positron emission tomography in patients with pathologic stage I lung adenocarcinoma. Cancer. 2006 Nov 15;107(10):2468-73. doi: 10.1002/cncr.22268.

  PMID: 17036361 BACKGROUND

• Yoshizawa A, Motoi N, Riely GJ, Sima CS, Gerald WL, Kris MG, Park BJ, Rusch VW, Travis WD. Impact of proposed IASLC/ATS/ERS classification of lung adenocarcinoma: prognostic subgroups and implications for further revision of staging based on analysis of 514 stage I cases. Mod Pathol. 2011 May;24(5):653-64. doi: 10.1038/modpathol.2010.232. Epub 2011 Jan 21.

  PMID: 21252858 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Recurrence

Interventions

Vinorelbine; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Sanghoon Jheon, Ph.D.

  Seoul National Univsersity Bundang Hospital

  STUDY DIRECTOR

Central Study Contacts

Sanghoon Jheon, Ph.D.

CONTACT

82317877140; jheon@snubh.org

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: Professor

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 3, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2020
• Last Updated: November 3, 2014

Record last verified: 2014-10

Locations

KR (1)