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

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Small Cell; Limited Stage; Carcinoma of Lung

Treatments: Radiation: hyperfractionated radiation therapy for both arms

Study type: Interventional

Funder types: Other

Identifiers

NCT01731548

2012-10-25

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

study arm

Experimental group

Description:

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）

Treatment:

Radiation: hyperfractionated radiation therapy for both arms

control arm

Active Comparator group

Description:

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).

Treatment:

Radiation: hyperfractionated radiation therapy for both arms