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Omitting Elective Nodal Irradiation and Irradiating Post-induction Versus Pre-induction Chemotherapy Tumor Extent for Limited-stage Small Cell Lung Cancer


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Carcinoma of Lung, Small Cell, Limited Stage

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Trial Information

Omitting Elective Nodal Irradiation and Irradiating Post-induction Versus Pre-induction Chemotherapy Tumor Extent for Limited-stage Small Cell Lung Cancer


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

local-regional progression

Outcome Time Frame:

at least 6 months

Safety Issue:

Yes

Principal Investigator

Ming Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

2012-10-25

NCT ID:

NCT01731548

Start Date:

June 2002

Completion Date:

December 2016

Related Keywords:

  • Carcinoma of Lung
  • Small Cell
  • Limited Stage
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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