Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer

United Kingdom Research and Innovation (UKRI)

Status and phase

Completed

Phase 3

Conditions

Lung Cancer

Treatments

Drug: carboplatin

Drug: etoposide

Drug: mesna

Drug: doxorubicin hydrochloride

Radiation: radiation therapy

Drug: cisplatin

Drug: ifosfamide

Drug: vincristine sulfate

Drug: cyclophosphamide

Study type

Interventional

Funder types

Other

Identifiers

NCT00002822

CDR0000064998

MRC-LU21

EU-96019

Details and patient eligibility

About

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 is a way to kill more tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effect of two combination chemotherapy regimens followed by radiation therapy in treating patients with small cell lung cancer.

Full description

OBJECTIVES:

Compare the survival rate in patients with newly diagnosed small cell lung cancer and good performance status treated with an intensive regimen of ifosfamide/carboplatin/etoposide with mid-cycle vincristine (VICE) vs. standard chemotherapy followed, as feasible, by thoracic radiotherapy.
Compare the adverse effects of treatment and quality of life (including psychological distress, physical status, and functional status and global quality of life) in these patients.
Compare the Rotterdam Symptom Checklist vs. the EORTC QLQ-C30 and LC13 quality-of-life questionnaires in relation to compliance and ability to detect differences between treatments.

OUTLINE: This is a randomized study.

The first group receives standard combination chemotherapy with doxorubicin/cyclophosphamide/etoposide (ACE) or cisplatin/etoposide (PE) every 3 weeks for 6 courses.

The second group receives intensive combination chemotherapy with carboplatin/ifosfamide/etoposide on days 1-3 with vincristine on day 14 (VICE). Courses repeat every 4 weeks for 6 courses.

Patients in both groups are considered for thoracic radiotherapy beginning 4-5 weeks after the first day of the last course of chemotherapy.

Concurrent prophylactic antibiotics should be given. Patients who relapse may receive further treatment at the clinician's option.

Patients are followed monthly for 6 months, every 2 months for up to 1 year, every 3 months for up to 2 years, every 6 months for 5 years, and annually thereafter.

PROJECTED ACCRUAL: A total of 400 patients will be entered over 3 years.

Enrollment

400 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Microscopically proven small cell lung cancer
- Diagnosis based on bronchial, mediastinal, pleural, lung, or lymph node biopsy, sputum cytology, or bronchial brushing or fine needle aspirate cytology
- No pleural fluid cytology
No prior therapy

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

WHO 0-2

Hematopoietic:

WBC more than 3,000
ANC more than 1,500
Platelets more than 100,000

Hepatic/Renal:

Alkaline phosphatase, aminotransferase, sodium, and LDH normal or no more than 1 of them abnormal
Creatinine or urea normal
Creatinine clearance or GFR more than 65 mL/min

Other:

No clinical evidence of infection
No prior or concurrent malignancy that interferes with protocol treatments or comparisons
No other condition that contraindicates treatment
Willing and able to complete quality-of-life questionnaires
- Hospital Anxiety and Depression Scale, Rotterdam Symptom Checklist, and EORTC questionnaires completed prior to randomization

PRIOR CONCURRENT THERAPY:

Biologic therapy: