A Prospective Randomized Study Comparing the Target Volume for Limited-stage Small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2016-12-31

Brief Summary

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We hypothesized that the local control for both arms were not statistically significant, when irradiation to the post-induction chemotherapy tumor volume is compared with irradiation to the pre-induction chemotherapy tumor volume.While elective nodal irradiation will be omitted for both arms.

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Detailed Description

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Conditions

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Carcinoma of Lung Small Cell Limited Stage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study arm

For patients who are randomized to study arm, (i.e. to irradiate the post-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the post-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm.

Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles.

Radiotherapy will be administered with cycle 3 chemotherapy（1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks）

Group Type EXPERIMENTAL

hyperfractionated radiation therapy for both arms

Intervention Type RADIATION

1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms

control arm

For patients who are randomized to control arm, (i.e. to irradiate the pre-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the pre-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm.

Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles.

Radiotherapy will be administered with cycle 3 chemotherapy (1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks).

Group Type ACTIVE_COMPARATOR

hyperfractionated radiation therapy for both arms

Intervention Type RADIATION

1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms

Interventions

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hyperfractionated radiation therapy for both arms

1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients were eligible if they had histologic or cytologic verification of small cell lung cancer (SCLC) and were radiographically confirmed limited-stage
* Patients with contralateral mediastinal and ipsilateral supraclavicular lymphadenopathy were also included.
* The patients should be between 18 and 75 years old without previous thoracic radiotherapy, chemotherapy or biotherapy.
* Karnofsky performance status was ≥ 80.
* Forced expiratory volume at 1 second (FEV1) ≥ 1 L.
* Had measurable or assessable disease.
* Neutrophilic granulocyte ≥ 1.5×109/L, haemoglobin ≥ 100 g/L, platelet count ≥ 100×109/L.
* Serum creatine and bilirubin \< 1.5 × the upper normal limit (UNL), aminotransferase \< 2 × UNL.
* Weight loss was less than 10% within 6 months before diagnosis.
* Written informed consent was required from all patients.

Exclusion Criteria

* Patients were ineligible if they had a history of other malignant diseases except for non-melanomatous skin cancer and carcinoma in situ of the cervix, or any contraindications for chemoradiotherapy, malignant pleural and/or pericardial effusion.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No