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Radiation Therapy Plus Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01134861
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : March 27, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Tracking Information
First Submitted Date  ICMJE May 28, 2010
First Posted Date  ICMJE June 2, 2010
Last Update Posted Date March 27, 2015
Study Start Date  ICMJE July 1994
Actual Primary Completion Date October 1998   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Overall Survival [ Time Frame: from date of randomization to date of death or last follow-up for patients still alive ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy Plus Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
Official Title  ICMJE A Three-Arm Phase III Study of Concomitant Versus Sequential Chemotherapy and Thoracic Radiotherapy for Patients With Locally Advanced Inoperable Non-small Cell Lung Cancer
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of various schedules of radiation therapy and combination chemotherapy using vinblastine and cisplatin or cisplatin and etoposide in treating patients with stage II or stage III non-small cell lung cancer that cannot be removed surgically.

Detailed Description

OBJECTIVES: I. Compare the survival rate of patients with locally advanced, unresectable non-small cell lung cancer randomized to concomitant vinblastine/cisplatin (VBL/CDDP) and thoracic radiotherapy versus sequential VBL/CDDP and once-daily thoracic radiotherapy. II. Compare the survival rate of such patients randomized to 2 courses of concomitant etoposide/cisplatin and hyperfractionated thoracic radiotherapy versus sequential VBL/CDDP and once-daily thoracic radiotherapy. III. Assess the frequency of treatment-related esophageal and hematologic toxicity/morbidity in patients on concomitant versus sequential chemoradiation treatment arms.

OUTLINE: Randomized study. The following acronyms are used: CDDP Cisplatin, NSC-119875 VBL Vinblastine, NSC-49842 VP-16 Etoposide, NSC-141540 Arm I: 2-Drug Combination Chemotherapy Followed by Radiotherapy. CDDP/VBL; followed by thoracic irradiation using photons of at least 6 MV (electrons may be used to boost the supraclavicular lymph nodes). Arm II: Radiotherapy plus 2-Drug Combination Chemotherapy. Thoracic irradiation using equipment as in Arm I; plus CDDP/VBL. Arm III: Hyperfractionated Radiotherapy plus 2-Drug Combination Chemotherapy. Thoracic irradiation using equipment as in Arm I; plus CDDP/VP-16.

PROJECTED ACCRUAL: A total of 597 patients will be entered over 3.1-4.2 years. If fewer than 6 patients/month are accrued, the feasibility of the study will be re-evaluated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: cisplatin
    100 mg/m2 i.v. over 30-60 minutes, days 1 & 29
  • Drug: Etoposide
    Oral etoposide given 50 mg b.i.d. X 10 only on RT treatment days 1-5, 8-12, 29-33, and 36-40. 75 mg/day if body surface area < 1.7 m2
    Other Name: VP-16
  • Drug: Vinblastine
    5 mg/m2 i.v. bolus weekly first 5 weeks of RT
  • Radiation: Radiation therapy
    63 Gy/7 wks/34 daily fractions (1.8 Gy X 25 fx then 2.0 Gy X 9 fX) beginning day 50 of protocol treatment
  • Drug: Cisplatin
    50 mg/m2 i.v. over 30-60 minutes on days 1, 8, 29, and 36
  • Radiation: Radiation therapy
    63 Gy/7 wks/34 daily fractions (1.8 Gy X 25 fx then 2.0 Gy X 9 fx) beginning day 1 of protocol treatment
  • Radiation: Radiation therapy
    69.6 Gy/6 wks/58 X 1.2 Gy twice daily fractions (at least 6 hours apart) beginning day 1 of protocol therapy
Study Arms  ICMJE
  • Active Comparator: Arm 1: Sequential ChemoRT
    Vinblastine 6 mg/m2 i.v. bolus weekly first 5 weeks Cisplatin 100 mg/m2 i.v. over 30-60 minutes, days 1 & 29 RT: 63 Gy/7 wks/34 daily fractions (1.8 Gy X 25 fx then 2.0 Gy X 9 fx) beginning day 50
    Interventions:
    • Drug: cisplatin
    • Drug: Vinblastine
    • Radiation: Radiation therapy
  • Experimental: Arm 2: Concurrent STD RT
    Vinblastine 5 mg/m2 i.v. bolus weekly first 5 weeks Cisplatin 100 mg/m2 i.v. over 30-60 minutes, days 1 & 29 RT: 63 GY/7 wks/34 daily fractions (1.8 Gy X 25 fx then 2.0 Gy X 9 fx) beginning day 1
    Interventions:
    • Drug: cisplatin
    • Drug: Vinblastine
    • Radiation: Radiation therapy
  • Experimental: Arm 3: Concurrent HFX RT
    Oral VP-16 50 mg b.i.d. X 10 only on RT treatment days 1-5, 8-12, 29-33, and 36-40 (76 mg/day if BSA < 1.7m2) Cisplatin 50 mg/m2 i.v. over 30-60 minutes on days 1, 8, 29, and 36 RT: 69.6 Gy/6 wks/58 X 1.2 Gy twice daily fractions (at least 6 hours apart) beginning day 1
    Interventions:
    • Drug: Etoposide
    • Drug: Cisplatin
    • Radiation: Radiation therapy
Publications *
  • Siddiqui F, Bae K, Langer CJ, Coyne JC, Gamerman V, Komaki R, Choy H, Curran WJ, Watkins-Bruner D, Movsas B. The influence of gender, race, and marital status on survival in lung cancer patients: analysis of Radiation Therapy Oncology Group trials. J Thorac Oncol. 2010 May;5(5):631-9.
  • Konski AA, Bhargavan M, Owen J, et al.: "Less is not always more": an economic analysis of Radiation Therapy Oncology Group 94-10. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-1080, S182, 2007.
  • Choy H, Swann S, Nabid A, et al.: Comparison of 5-year survival between RTOG-94-10 and a phase 2 study of induction chemotherapy followed by efaproxiral + radiotherapy in patients with locally advanced NSCLC. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-49, S28-9, 2006.
  • Bradley J. A review of radiation dose escalation trials for non-small cell lung cancer within the Radiation Therapy Oncology Group. Semin Oncol. 2005 Apr;32(2 Suppl 3):S111-3. Review.
  • Langer CJ, Swann S, Curran W, et al.: Reassessing prognostic factors in the era of combined modality therapy for locally advanced NSCLC: a retrospective analysis of RTOG 9410 and 9801. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-65, S39, 2005.
  • Machtay M, Hsu C, Komaki R, Sause WT, Swann RS, Langer CJ, Byhardt RW, Curran WJ. Effect of overall treatment time on outcomes after concurrent chemoradiation for locally advanced non-small-cell lung carcinoma: analysis of the Radiation Therapy Oncology Group (RTOG) experience. Int J Radiat Oncol Biol Phys. 2005 Nov 1;63(3):667-71. Epub 2005 May 31.
  • Machtay M, Swann S, Komaki R, et al.: Overall treatment time during concurrent chemoradiotherapy and outcomes: an RTOG secondary analysis. [Abstract] Lung Cancer 50 (Suppl 2): A-O-042, S17, 2005.
  • Machtay M, Swann S, Komaki R, et al.: What is the meaning of local-regional control after chemoradiation for locally advanced NSCLC? An RTOG analysis. [Abstract] Lung Cancer 50 (Suppl 2): A-O-041, S17, 2005.
  • Swann RS, Machtay M, Komaki R, et al.: Impact of overall treatment time during concurrent chemoradiotherapy for locally advanced NSCLC: an RTOG secondary analysis. [Abstract] J Clin Oncol 23 (Suppl 16): A-7061, 635s, 2005.
  • Werner-Wasik M, Scott C, Curran WJ, et al.: Correlation between acute esophagitis and late pneumonitis in patients (pts) with locally advanced non-small cell lung cancer (LA-NSCLC) receiving concurrent thoracic radiotherapy (RT) and chemotherapy: a multivariate analysis of the Radiation Therapy Oncology Group (RTOG) database. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1192, 2002.
  • Sause W, Scott C, Byhardt R, et al.: Combined chemotheray radiation therapy treatment in unresected non-small cell lung cancer: Radiation Therapy Oncology Group (RTOG) experience. Lung Cancer 29(suppl 2): 2000.
  • Curran WJ, Scott CB, Langer CJ, et al.: Long-term benefit is observed in a phase III comparison of sequential vs concurrent chemo-radiation for patients with unresected stage III nsclc: RTOG 9410. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2499, 2003.
  • Langer CJ, Hsu C, Curran WJ, et al.: Elderly patients (pts) with locally advanced non-small cell lung cancer (LA-NSCLC) benefit from combined modality therapy: secondary analysis of Radiation Therapy Oncology Group (RTOG) 94-10. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1193, 2002.
  • Langer CJ, Hsu C, Curran W, et al.: Do elderly patients (pts) with locally advanced non-small cell lung cancer (NSCLC) benefit from combined modality therapy? A secondary analysis of RTOG 94-10. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-36, 20-21, 2001.
  • Movsas B, Scott C, Curran W, et al.: A quality-adjusted time without symptons or toxicity (QTWiST) analysis of Radiation Therapy Oncology Group (RTOG) 94-10. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1247, 313a, 2001.
  • Curran WJ, Scott C, Langer C, et al.: Phase III comparison of sequential vs concurrent chemoradiation for patients with unresected stage III non-small cell lung cancer (NSCLC): initial report of Radiation Therapy Oncology Group (RTOG) 9410. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A1891, 2000.
  • Komaki R, Seiferheld W, Curran W, et al.: Sequential vs. concurrent chemotherapy and radiation therapy for inoperable non-small cell lung cancer (NSCLC): analysis of failures in a phase III study (RTOG 9410). [Abstract] Int J Radiat Oncol Biol Phys 48 (3 suppl): A-5, 113, 2000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2013)
610
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date October 1998   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS: Locoregionally advanced, inoperable, non-small cell lung cancer with no evidence of distant metastases, i.e.: Stage II/IIIA medically inoperable disease Stage IIIA/IIIB unresectable disease No pleural effusion Appearance after an invasive thoracic procedure allowed No more than 5% weight loss within 3 months prior to diagnosis Confirmed N2 disease should first be evaluated for protocol RTOG-9309

PATIENT CHARACTERISTICS: Age: At least 18 Performance status: Karnofsky 70%-100% Hematopoietic: AGC at least 2,000 Platelets at least 100,000 Hemoglobin at least 8.0 g/dL Hepatic: (unless abnormality caused by benign disease) Bilirubin no more than 1.5 times normal AST no more than 1.5 times normal Renal: Creatinine no more than 1.5 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No angina No congestive heart failure No uncontrolled arrhythmia Other: No synchronous or prior invasive malignancy within 3 years except nonmelanomatous skin cancer No pregnant women Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic or neck radiotherapy Surgery: No prior complete or nearly complete tumor resection

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01134861
Other Study ID Numbers  ICMJE RTOG-9410
U10CA021661 ( U.S. NIH Grant/Contract )
CDR0000063640 ( Other Identifier: Radiation Therapy Oncology Group )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radiation Therapy Oncology Group
Study Sponsor  ICMJE Radiation Therapy Oncology Group
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • NRG Oncology
Investigators  ICMJE
Study Chair: Walter J. Curran, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
PRS Account Radiation Therapy Oncology Group
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP