Radiation Therapy With or Without Vinorelbine and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Medical Research Council
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00253591
First received: November 11, 2005
Last updated: February 26, 2011
Last verified: July 2007
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as vinorelbine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with vinorelbine and cisplatin is more effective than radiation therapy alone in treating non-small cell lung cancer.
PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy together with vinorelbine and cisplatin works and compares it to radiation therapy alone in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: vinorelbine tartrate Radiation: radiation therapy |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomised Phase II/III Trial of Induction Chemotherapy Followed by Continuous Hyperfractionated Accelerated Radiotherapy (CHART) Versus CHART Alone in Patients With Inoperable Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Response (complete or partial response) [ Designated as safety issue: No ]
- Cost effectiveness [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2005 |
| Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Compare the overall survival of patients with stage I-III non-small cell lung cancer treated with vinorelbine, cisplatin, and continuous hyperfractionated accelerated radiotherapy (CHART) vs CHART alone.
Secondary
- Compare the response, progression-free survival, and quality of life of patients treated with these regimens.
- Compare the toxic effect of these regimens in these patients.
- Compare the cost effectiveness of these regimens in these patients.
- Compare the local and distant control in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo continuous hyperfractionated accelerated radiotherapy (CHART) 3 times a day for 12 consecutive days.
- Arm II: Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks later, patients undergo CHART as in arm I.
Quality of life is assessed periodically.
After completion of study treatment, patients are evaluated periodically for at least 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage I-III non-small cell lung cancer
- Inoperable or patient refuses surgery
- Disease can be encompassed within the radical radiotherapy treatment volume
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-1
Life expectancy
- More than 3 months
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
Hepatic
- Bilirubin < 1.5 times upper limit of normal
Renal
- Glomerular filtration rate > 60 mL/min
Cardiovascular
- No uncontrolled arterial hypertension
- No ischemic heart disease
Pulmonary
- FEV_1 > 50% of predicted OR
- DLCO > 50% of predicted
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior or current malignancy that would preclude study treatment
- Medically stable
- No unstable diabetes
- No infection
- No hypercalcemia
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior chemotherapy
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253591
Locations
| United Kingdom | |
| Wansbeck General Hospital | |
| Ashington, England, United Kingdom, NE63 9JJ | |
| Bristol Haematology and Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| Cheltenham General Hospital | |
| Cheltenham, England, United Kingdom, GL53 7AN | |
| Derbyshire Royal Infirmary | |
| Derby, England, United Kingdom, DE1 2QY | |
| University Hospital of North Durham | |
| Durham, England, United Kingdom, DH1 5TW | |
| Queen Elizabeth Hospital | |
| Gateshead, England, United Kingdom, NE9 6SX | |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | |
| Northwood, England, United Kingdom, HA6 2RN | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Kings Mill Hospital | |
| Nottinghamshire, England, United Kingdom, NG17 4JL | |
| Churchill Hospital | |
| Oxford, England, United Kingdom, OX3 7LJ | |
| Cancer Research Centre at Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Great Western Hospital | |
| Swindon, England, United Kingdom, SN3 6BB | |
| Worcester Royal Hospital | |
| Worcester, England, United Kingdom, WR5 1DD | |
| Yeovil District Hospital | |
| Yeovil, England, United Kingdom, BA21 4AT | |
| Beatson West of Scotland Cancer Centre | |
| Glasgow, Scotland, United Kingdom, G12 0YN | |
| Crosshouse Hospital | |
| Kilmarnock, Scotland, United Kingdom, KA2 OBE | |
| Velindre Cancer Center at Velindre Hospital | |
| Cardiff, Wales, United Kingdom, CF14 2TL | |
| Llandough Hospital | |
| Llandough, Wales, United Kingdom, CF64 2XX | |
| Royal Gwent Hospital | |
| Newport Gwent, Wales, United Kingdom, NP9 2UB | |
Sponsors and Collaborators
Medical Research Council
Investigators
| Study Chair: | Matthew Hatton, MD | Cancer Research Centre at Weston Park Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00253591 History of Changes |
| Other Study ID Numbers: | CDR0000449972, MRC-LU23, EU-20535, EU-INCH-20535, EudraCT-2004-004438-15 |
| Study First Received: | November 11, 2005 |
| Last Updated: | February 26, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I non-small cell lung cancer 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 Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Vinorelbine Cisplatin |
Vinblastine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013