Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT00002858

Collaborator

(none)

280

Enrollment

Locations

14.7

Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for small cell lung cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy using two different doses of cyclophosphamide followed by alternating chemotherapy and radiation therapy in treating patients with small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Radiation: radiation therapy	Phase 3

Detailed Description

OBJECTIVES: I. Compare the effect on 2-year disease-free survival of two different doses of cyclophosphamide as part of first induction chemotherapy followed by alternating chemotherapy and chest irradiation in patients with limited stage small cell lung cancer.

OUTLINE: This is a randomized study. Patients are stratified by participating institution. All patients receive 2 courses of induction chemotherapy with doxorubicin, etoposide, cisplatin, and cyclophosphamide. For the first course, one group of patients receives a lower dose of cyclophosphamide than the other group. Both groups receive the same, and still lower, dose of cyclophosphamide during the second course. Beginning 1 week after the completion of induction therapy, patients receive 3 alternating courses each of radiotherapy to the mediastinal and supraclavicular areas delivered over 10-12 days and chemotherapy as in the second course of induction. Each course is initiated after a 1-week rest. Patients receive a final chemotherapy course beginning 4 weeks after the previous chemotherapy course. Patients are followed every 6 months for survival.

PROJECTED ACCRUAL: A total of 280 patients will be entered.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER

Study Start Date :

Mar 1, 1993

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically proven small cell lung cancer with no distant metastases Size of initial lesion suitable for total irradiation Positive subclavicular nodes allowed No malignant pleural effusion No extension into contralateral lung

PATIENT CHARACTERISTICS: Age: Under 70 Performance status: Karnofsky 60%-100% Hematopoietic: WBC greater than 2,000 Platelets greater than 125,000 Hepatic: Not specified Renal: Creatinine less than 1.1 mg/dL (100 micromoles/L) Cardiovascular: No myocardial infarction within 6 months No other cardiovascular disease that precludes protocol treatment Other: No hearing loss No prior or concurrent malignancy except: Basal cell skin carcinoma In situ carcinoma of the cervix Accessible for follow-up

PRIOR CONCURRENT THERAPY: No prior chemotherapy, radiotherapy, or surgery

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier Regional et Universitaire d'Angers	Angers	France	49033
2	Centre Paul Papin	Angers	France	49036
3	Institut Bergonie	Bordeaux	France	33076
4	Centre Regional Francois Baclesse	Caen	France	14076
5	Hopital Antoine Beclere	Clamart	France	92141
6	Centre Hospitalier Sud Francilien - Site Corbeil	Corbeil	France	91100
7	Hopital Intercommunal De Creteil	Creteil	France	94010
8	Hopital De La Trouhade	Dijon	France	21034
9	Centre de Lute Contre le Cancer,Georges-Francois Leclerc	Dijon	France	21079
10	C.H. General Andre Boulloche	Montbeliard	France	25209
11	CRLCC Nantes - Atlantique	Nantes-Saint Herblain	France	44805
12	Centre Antoine Lacassagne	Nice	France	06189
13	Hopital Haut Leveque	Pessac	France	33604
14	C.H. De Saumur	Saumur	France	49403
15	Hopitaux Universitaire de Strasbourg	Strasbourg	France	67091
16	Institut Claudius Regaud	Toulouse	France	31052
17	Centre Alexis Vautrin	Vandoeuvre-les-Nancy	France	54511
18	CHRU de Nancy - Hopitaux de Brabois	Vandoeuvre-Les-Nancy	France	54511
19	Institut Gustave Roussy	Villejuif	France	F-94805