Clinical trial NCT00253591: Radiation Therapy With or Without Vinorelbine and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lung Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-11-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 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

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Progression-free survival
measure: Toxicity
measure: Response (complete or partial response)
measure: Cost effectiveness
Other outcomes:
Locations:
city: Ashington
country: United Kingdom
facility: Wansbeck General Hospital
state: England
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: England
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
state: England
city: Derby
country: United Kingdom
facility: Derbyshire Royal Infirmary
state: England
city: Durham
country: United Kingdom
facility: University Hospital of North Durham
state: England
city: Gateshead
country: United Kingdom
facility: Queen Elizabeth Hospital
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Northern Centre for Cancer Treatment at Newcastle General Hospital
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre at Mount Vernon Hospital
state: England
city: Nottinghamshire
country: United Kingdom
facility: Kings Mill Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital NHS Trust
state: England
city: Oxford
country: United Kingdom
facility: Churchill Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Cancer Research Centre at Weston Park Hospital
state: England
city: Swindon
country: United Kingdom
facility: Great Western Hospital
state: England
city: Worcester
country: United Kingdom
facility: Worcester Royal Hospital
state: England
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
state: England
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
state: Scotland
city: Kilmarnock
country: United Kingdom
facility: Crosshouse Hospital
state: Scotland
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Center at Velindre Hospital
state: Wales
city: Llandough
country: United Kingdom
facility: Llandough Hospital
state: Wales
city: Newport Gwent
country: United Kingdom
facility: Royal Gwent Hospital
state: Wales
Study officials:
affiliation: Cancer Research Centre at Weston Park Hospital
name: Matthew Hatton, MD
role: STUDY_CHAIR
References: