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

NCT ID: NCT01731548

Condition: Carcinoma of Lung
Small Cell
Limited Stage

Conditions: Official terms:
Small Cell Lung Carcinoma
Lung Neoplasms

Study type: Interventional

Study phase: Phase 2/Phase 3

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: hyperfractionated radiation therapy for both arms
Description: 1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms
Arm group label: control arm
Arm group label: study arm

Summary: 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Sun Yat-Sen University, Cancer Center

Address:
City: Guangzhou
Zip: 510060
Country: China

Status: Recruiting

Contact:
Last name: Hui Liu, MD. PHD

Phone: 086-020-87343033
Email: liuhui@sysucc.org.cn

Contact backup:
Last name: Yong Bao, MD

Phone: 086-020-87343504
Email: baoyong@sysucc.org.cn

Start date: June 2002

Completion date: December 2016

Lead sponsor:
Agency: Zhejiang Cancer Hospital
Agency class: Other

Collaborator:
Agency: Sun Yat-sen University
Agency class: Other

Source: Zhejiang Cancer Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01731548

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