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

NCT02337712 | Unknown Phase 2

• 1 other identifier: 2014-FXY-037
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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).

Conditions

Small Cell Lung Cancer

Keywords

Small cell lung cancer; Radiotherapy; Dose fractionation

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  2 years

Study Arms (2)

q.d. RT

EXPERIMENTAL

q.d. RT (65 Gy in 26 fractions) to the chest and concurrent etoposide and cisplatin

Radiation: q.d. RT; Drug: etoposide and cisplatin

b.i.d.RT

ACTIVE COMPARATOR

b.i.d.RT (45Gy in 30 fractions) to the chest and concurrent etoposide and cisplatin

Radiation: b.i.d.RT; Drug: etoposide and cisplatin

Interventions

q.d. RT RADIATION

65 Gy in 26 fractions

q.d. RT

b.i.d.RT RADIATION

45 Gy in 30 fractions

b.i.d.RT

etoposide and cisplatin DRUG

etoposide and cisplatin concurrent with radiotherapy

b.i.d.RT; q.d. RT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen university cancer center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (17)

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• Qiu B, Li Q, Liu J, Huang Y, Pang Q, Zhu Z, Yang X, Wang B, Chen L, Fang J, Lin M, Jiang X, Guo S, Guo J, Wang D, Liu F, Chu C, Huang X, Xie C, Liu H. Moderately Hypofractionated Once-Daily Compared With Twice-Daily Thoracic Radiation Therapy Concurrently With Etoposide and Cisplatin in Limited-Stage Small Cell Lung Cancer: A Multicenter, Phase II, Randomized Trial. Int J Radiat Oncol Biol Phys. 2021 Oct 1;111(2):424-435. doi: 10.1016/j.ijrobp.2021.05.003. Epub 2021 May 13.

  PMID: 33992717 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Etoposide; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Hui Liu, Professor

  Sun yat-sen universtiy cancer center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 14, 2015
• Study Start: January 1, 2015
• Primary Completion: September 30, 2020
• Study Completion: December 1, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

CN (1)