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Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy in Limited Small-cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02337712
Recruitment Status : Recruiting
First Posted : January 14, 2015
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Hui Liu, Sun Yat-sen University

Brief Summary:
This Phase II randomized study is to determine whether once-daily simultaneous modulated accelerated thoracic radiotherapy (RT) resulted in better survival than twice-daily RT for patients with limited-stage small-cell lung cancer (LD-SCLC).

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Radiation: q.d. RT Radiation: b.i.d.RT Phase 2

Detailed Description:

This Phase II randomized study is to determine whether once-daily (qd)simultaneous modulated accelerated thoracic radiotherapy resulted in better survival than twice-daily(bid) RT for patients with limited-stage small-cell lung cancer (LD-SCLC).

All patients received four cycles of etoposide and cisplatin (EP), each of 3 days' duration and separated by 21 days. Thoracic RT was initiated at the first or second chemotherapy. Qd RT includes the delivery of 65 Gy in 26 fractions delivered on weekdays for a total of 33 days. Bid RT includes the delivery of 45 Gy in 30 fractions delivered on weekdays for a total of 19 days. After the chest RT and the fourth cycle of EP, prophylactic cranial irradiation is administered to all patients with a complete remission. 204 patients are needed to be enrolled for an 80% power to detect an improvement in 3-year progression-free survival rate from the expected 25% to 40%.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy Compared With Twice-daily Radiotherapy in Limited Small-cell Lung Cancer Treated Concurrently With Cisplatin and Etoposide
Study Start Date : January 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: q.d. RT
q.d. RT (65 Gy in 26 fractions) to the chest and four cycles of etoposide and cisplatin
Radiation: q.d. RT
65 Gy in 26 fractions

Active Comparator: b.i.d.RT
b.i.d.RT (45Gy in 30 fractions) to the chest and four cycles of etoposide and cisplatin
Radiation: b.i.d.RT
45 Gy in 30 fractions




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 3-year ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologic confirmation of SCLC. Imaging studies' confirmation of limited stage.
  • No previous chest radiotherapy, chemotherapy or biotherapy.
  • Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • White blood cell count ≥4×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L; serum creatinine and total bilirubin 1.5 times or less the upper limits of normal (ULN), aspartate aminotransferase two times or less the ULN.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Weight loss ≤10% within the past 3 months.
  • Forced expiratory volume in 1 s >1 L.

Exclusion Criteria:

  • Previous or recent another malignancy.
  • A myocardial infarction within 6 months or had uncontrolled congestive heart failure, uncontrolled arrhythmia.
  • Malignant pleural or pericardial effusion.
  • Pregnant or Lactating.
  • Weight loss >10% within the past 3 months.
  • Drug addiction, long-term alcohol abuse and AIDS patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337712


Contacts
Contact: Bo Qiu, Attending +86-020-87343031 qiubo@sysucc.org.cn

Locations
China, Guangdong
Sun yat-sen university cancer center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Bo Qiu, Attending    +86-020-87343031    qiubo@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Hui Liu, Professor Sun yat-sen universtiy cancer center

Publications:

Responsible Party: Hui Liu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02337712     History of Changes
Other Study ID Numbers: 2014-FXY-037
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: March 2017

Keywords provided by Hui Liu, Sun Yat-sen University:
Small cell lung cancer
Radiotherapy
Dose fractionation

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action