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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01134861
First received: May 28, 2010
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: Etoposide
Drug: Vinblastine
Radiation: Radiation therapy
Drug: Cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: from date of randomization to date of death or last follow-up for patients still alive ] [ Designated as safety issue: No ]

Enrollment: 610
Study Start Date: July 1994
Primary Completion Date: October 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: cisplatin
100 mg/m2 i.v. over 30-60 minutes, days 1 & 29
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
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
Drug: cisplatin
100 mg/m2 i.v. over 30-60 minutes, days 1 & 29
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 1 of protocol treatment
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
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: Cisplatin
50 mg/m2 i.v. over 30-60 minutes on days 1, 8, 29, and 36
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134861

Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Walter J. Curran, MD Kimmel Cancer Center (KCC)
  More Information

Additional Information:
Publications:
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.
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.
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, 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.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01134861     History of Changes
Other Study ID Numbers: RTOG-9410, U10CA021661, CDR0000063640
Study First Received: May 28, 2010
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Etoposide
Vinblastine
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014