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Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003364
First Posted: January 23, 2004
Last Update Posted: December 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with radiation therapy may kill more tumor cells. The best timing for radiation therapy and combination chemotherapy in treating limited stage small cell lung cancer is not yet known .

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy given at different times along with combination chemotherapy in treating patients with limited stage small cell lung cancer.


Condition Intervention Phase
Lung Cancer Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate Radiation: radiation therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomised Study of Timing of Thoracic Irradiation in Small Cell Lung Cancer (Study 8)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 398
Study Start Date: January 1993
Study Completion Date: August 2006
Detailed Description:

OBJECTIVES: I. Determine whether long term survival is affected by the timing of thoracic radiotherapy in patients with limited stage small cell lung cancer who are receiving combination chemotherapy. II. Determine whether the development of local recurrence and distant metastases are affected by the timing of thoracic radiotherapy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. All patients receive cyclophosphamide, doxorubicin, and vincristine by IV bolus alternating with 3 days of daily etoposide IV infusion over 60-120 minutes and cisplatin IV infusion over 30 minutes. This treatment alternates every 3 weeks for six courses. Patients are randomized to have thoracic radiotherapy either with course 2 (arm I) or with course 6 (arm II) of chemotherapy. Patients in arm I are given 1 week of rest between radiotherapy and the second course of chemotherapy. If there is no disease progression after chemotherapy and locoregional irradiation, and a repeat brain scan is negative, patients receive prophylactic brain irradiation. Patients are followed monthly for the first year and then every 2 months thereafter.

PROJECTED ACCRUAL: This study will accrue 398 patients.

  Eligibility

Information from the National Library of Medicine

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:   up to 74 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed limited stage small cell lung cancer Limited disease defined as within the hemithorax, mediastinum, or ipsilateral supraclavicular nodes No evidence of extensive disease (i.e., contralateral lung or contralateral supraclavicular nodes) No metastatic disease Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: Under 75 Performance status: ECOG 0-3 Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine normal OR Creatinine clearance greater than 50 mL/min OR Pentetic acid/ethylenediaminetetraacetic acid clearance greater than 70 mL/min Cardiovascular: No myocardial infarction in the 3 months prior to diagnosis No pericardial effusion Pulmonary: No pleural effusion seen on chest x-ray Pleural effusion identified on CT allowed, if not visible on chest x-ray Other: No medical condition that excludes the use of chemotherapy or thoracic irradiation Must be able to tolerate the prescribed study radiotherapy No other malignant tumor for at least 3 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No concurrent chemotherapy Endocrine therapy: Concurrent prednisone or other corticosteroids for hypercalcemia allowed Radiotherapy: No prior radiotherapy Surgery: Not specified

  Contacts and Locations
Information from the National Library of Medicine

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): NCT00003364


Locations
United Kingdom
Heatherwood Hospital
Ascot, England, United Kingdom, SL5 8AA
Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
Addenbrooke's NHS Trust
Cambridge, England, United Kingdom, CB2 2QQ
Broomfield Hospital
Chelmsford, Essex, England, United Kingdom, CM1 5ET
Essex County Hospital
Colchester, England, United Kingdom
Royal Free Hospital
Hampstead, London, England, United Kingdom, NW3 2QG
Cookridge Hospital
Leeds, England, United Kingdom, LS16 6QB
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Guy's and St. Thomas' Hospitals Trust
London, England, United Kingdom, SE1 9RT
Charing Cross Hospital
London, England, United Kingdom, W6 8RF
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom, WIT 3AA
Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Peterborough Hospitals Trust
Peterborough, England, United Kingdom, PE3 6DA
Southend NHS Trust Hospital
Westcliff-On-Sea, England, United Kingdom
Sponsors and Collaborators
London Lung Cancer Group
Investigators
Study Chair: Stephen G. Spiro University College London Hospitals
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00003364     History of Changes
Other Study ID Numbers: CDR0000066349
LLCG-TR8SCLC
EU-98011
First Submitted: November 1, 1999
First Posted: January 23, 2004
Last Update Posted: December 19, 2013
Last Verified: May 2007

Keywords provided by National Cancer Institute (NCI):
limited stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Etoposide
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators