Cisplatin, Etoposide, and Two Different Schedules of Radiation Therapy in Treating Patients With Limited Stage Small Cell Lung Cancer - Full Text View

Sponsored by:	Christie Hospital NHS Foundation Trust
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00433563

Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which schedule of radiation therapy is more effective when given together with chemotherapy in treating small cell lung cancer.

PURPOSE: This randomized phase III trial is studying two different schedules of radiation therapy to compare how well they work when given together with cisplatin and etoposide in treating patients with limited stage small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: cisplatin Drug: etoposide Procedure: radiation therapy	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Etoposide Cisplatin Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A 2-Arm Randomized Controlled Trial of Concurrent Chemo-Radiotherapy Comparing Twice-Daily and Once-Daily Radiotherapy Schedules in Patients With Limited Stage Small Cell Lung Cancer (SCLC) and Good Performance Status [CONVERT]

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

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Local progression-free survival [ Designated as safety issue: No ]
Metastasis-free survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Response rate [ Designated as safety issue: No ]
Cytotoxic dose intensity [ Designated as safety issue: Yes ]
Radiotherapy dose intensity [ Designated as safety issue: No ]

Estimated Enrollment:	532
Study Start Date:	April 2008
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Compare overall survival of patients with limited stage small cell lung cancer treated with chemoradiotherapy comprising cisplatin, etoposide, and once vs twice daily radiotherapy.

Secondary

Compare local progression-free survival of patients treated with these regimens.
Compare metastasis-free survival of patients treated with these regimens.
Compare the toxicity of these regimens in these patients.
Compare response rates in patients treated with these regimens.
Compare the cytotoxic dose intensity of these regimens in these patients.
Compare the dose intensity of two different schedules of radiotherapy in these patients.

OUTLINE: This is a multicenter, randomized, controlled study. Patients are stratified according to participating center, ECOG performance status (0-1 vs 2), and lactic dehydrogenase, sodium, and alkaline phosphatase levels. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive cisplatin IV over 2 hours on days 1-3 OR on day 1 only and etoposide IV over 45-90 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses. During course 2, patients undergo concurrent radiotherapy once daily 5 days a week for 6½ weeks (total of 33 fractions).
Arm II: Patients receive cisplatin and etoposide as in arm I. During courses 2 and 3, patients undergo concurrent radiotherapy twice daily 5 days a week for 3 weeks (total of 30 fractions).

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Beginning 3-4 weeks after completion of chemoradiotherapy, patients in both arms achieving a complete or partial response with no evidence of brain metastasis undergo prophylactic cranial irradiation once daily 5 days a week for 2 weeks (total of 10 fractions).

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 532 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 small cell lung cancer
- Limited stage disease that can be encompassed within a radical radiation portal
- No mixed small cell or non-small cell histologic features
No more than 1 of the following adverse factors:
- Alkaline phosphatase > 1.5 times upper limit of normal
- Sodium < lower limit of normal
No malignant pleural or pericardial effusions

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Absolute neutrophil count > 1,500/mm³
Platelet count > 100,000/mm³
Creatinine normal
Creatinine clearance ≥ 50 mL/min
FEV_1 > 1 L OR > 40% of predicted
DLCO > 40% of predicted
No other medical condition that would preclude study treatment
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

No prior surgical resection of the primary tumor
No prior radiotherapy for lung cancer
No other prior or concurrent therapy that would preclude study treatment
No concurrent epoetin alfa for anemia
No concurrent sargramostim (GM-CSF)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433563

Locations

United Kingdom, England
Cancer Research Centre at Weston Park Hospital	Recruiting
Sheffield, England, United Kingdom, S1O 2SJ
Contact: Penella J. Woll, MD, PhD 44-114-226-5206
Christie Hospital	Recruiting
Manchester, England, United Kingdom, M20 4BX
Contact: Corinne Faivre-Finn, MD 44-1-61-446-3000 corinne.finn@christie-tr.nwest.nhs.uk
Cookridge Hospital	Recruiting
Leeds, England, United Kingdom, LS16 6QB
Contact: Michael Snee, MD 44-113-392-4347 michael.snee@leedsth.nhs
Mount Vernon Cancer Centre at Mount Vernon Hospital	Recruiting
Northwood, England, United Kingdom, HA6 2RN
Contact: Ethan Lyn, MD 44-1923-844-551 ethanlyn@mac.com
Northern Centre for Cancer Treatment at Newcastle General Hospital	Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
Contact: Rhona McMenemin 44-191-219-4200
University College Hospital	Recruiting
London, England, United Kingdom, NW1 2PG
Contact: Siow M. Lee, MD, PhD, FRCP 44-20-7380-9091 sm.lee@uclh.org
United Kingdom, Scotland
Beatson West of Scotland Cancer Centre	Recruiting
Glasgow, Scotland, United Kingdom, G11 6NT
Contact: Nazia Mohammed 44-141-211-6205
Edinburgh Cancer Centre at Western General Hospital	Recruiting
Edinburgh, Scotland, United Kingdom, EH4 2XU
Contact: Allan Price, MD 0131-537-2204/5 A.Price@ed.ac.uk

Sponsors and Collaborators

Christie Hospital NHS Foundation Trust

Investigators

Study Chair:

Corinne Faivre-Finn, MD

Christie Hospital NHS Foundation Trust

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000531709, CHNT-CONVERT, CHNT-CTAAC-CONVERT-C17052/A815, EU-20669
Study First Received:	February 8, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00433563
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

limited stage small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Cisplatin

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009