Twice-daily SIB Radiotherapy Versus Standard Radiotherapy for Patients With SCLC

NCT03214003 | Completed

• 1 other identifier: 2017YJZ19
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a multicenter, perspective, non-blinded, randomized controlled phase 3 trial. In order to establish whether the SIB technique can improve the results of twice-daily chemo-RT for patients with LS-SCLC, the investigators will primarily compare survival of patients treated with standard chemotherapy (cisplatin and etoposide) and either SIB twice-daily RT or standard dose twice-daily RT.

Conditions

Small Cell Lung Cancer Limited Stage; Radiotherapy

Keywords

small cell lung cancer limited stage; twice-daily radiotherapy; simultaneous integrated boosting technique

Outcome Measures

Primary Outcomes (1)

• Overall survival

  from the starting date of treatment until the date of death from any cause

  5 years

Secondary Outcomes (4)

• Local Progression Free Survival

  5 years

• Metastasis Free Survival

  5 years

• health related quality of life

  from baseline, immediately after radiotherapy and an average of 3 months up to 24 months. Then through study completion, an average of 6 months.From date of randomization until the date of death from any cause, assessed up to 120 months.

• acute and late toxicity

  from baseline, immediately after radiotherapy and an average of 1 week up to 12 weeks, an average of 3 months up to 24 months. Up to 120 weeks.

Study Arms (2)

SIB group

EXPERIMENTAL

Patients in this group will receive concurrent twice-daily radiotherapy by SIB technique (95%PGTV 54Gy, 95%PTV 45Gy,both in 30 twice-daily fractions over 3 weeks, 5 days per week) and chemotherapy (etoposide and cisplatin).

Radiation: SIB

BID group

ACTIVE COMPARATOR

Patients in this group will receive concurrent twice-daily standard radiotherapy (95%PTV 45Gy in 30 twice-daily fractions over 3 weeks, 5 days per week, without SIB) and chemotherapy (etoposide and cisplatin).

Radiation: Standard

Interventions

SIB RADIATION

patients will recieve twice-daily radiotherapy by simultaneous integrated boosting technique concurrent with chemotherapy

Also known as: chemotherapy with etoposide and cisplatin

SIB group

Standard RADIATION

patients will recieve standard twice-daily radiotherapy concurrent with chemotherapy

Also known as: chemotherapy with etoposide and cisplatin

BID group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Read the patient information and Sign the informed consent before enrollment
• Either sex, age ≥18 and ≤70
• Histologically or cytologically confirmed SLCL
• Limited stage disease(AJCC, 2009 version 7), stage I-III(T any, N any, M0) that can be safely treated with definitive radiation doses, excludes T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan, clinical nonmalignant diagnosis by investigator when the pleural is too few to obtain cytological evidence.
• measurable lesion according RECIST 1.1
• PS ECOG 0-1
• having zero to two cycles of systemic chemotherapy with etoposide and cisplatin (cisplatin 60-80 mg/m2 at day1 or divided into two to three days, etoposide 100-120 mg/m2 at day 1 to 3, Q21d, and the treatment delay between two cycles shouldn't be more than 14days).
• patients especially female patients must satisfy the investigator that they are not pregnant, or are not of childbearing potential, or are using adequate contraception. Man must also use adequate contraception
• adequate haematological function: white blood cell ≥3.0×109/L , neutrophils ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥90g/L.
• adequate liver and renal function: total bilirubin ≤1.5 ×upper limit normal , alanine transaminase and aspartate aminotransferase ≤1.5 ×upper limit normal, normal serum creatinine and/or calculated creatinine clearance ≥60ml/min.

You may not qualify if:

• prior surgical resection of the primary tumor or prior RT for lung cancer
• mixed small-cell and non-small-cell histological features
• contemporaneous immunotherapy or target therapy
• pregnancy or lactation
• physical or mental disease that could impact treatment plan
• unable to understand the trial, or could not follow the process
• to refuse the sign the informed consent.
• no history of previous malignancy in the past 5 years (except non-melanomatous skin or in situ servix carcinoma)
• be allergic to any known protocol in this trail
• be enrolled in other clinical trial in past 30days

Sponsors & Collaborators

• Anhui Shi, MD: lead
• Sun Yat-sen University: collaborator
• Fudan University: collaborator
• Xijing Hospital: collaborator
• Henan Cancer Hospital: collaborator
• Jilin Provincial Tumor Hospital: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Air Force General Hospital of the PLA: collaborator
• China-Japan Friendship Hospital: collaborator
• Peking University Third Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Beijing Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Peking University People's Hospital: collaborator
• Peking University First Hospital: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

Location

Related Publications (1)

• Yu J, Jiang L, Zhao L, Yang X, Wang X, Yang D, Zhuo M, Chen H, Huang W, Zhu Z, Zhang M, Song Y, Li Q, Ma Z, Wang Q, Qu Y, Yu R, Yu H, Zhao J, Shi A; Trial Management Group. High-dose hyperfractionated simultaneous integrated boost radiotherapy versus standard-dose radiotherapy for limited-stage small-cell lung cancer in China: a multicentre, open-label, randomised, phase 3 trial. Lancet Respir Med. 2024 Oct;12(10):799-809. doi: 10.1016/S2213-2600(24)00189-9. Epub 2024 Aug 12.

  PMID: 39146944 DERIVED

MeSH Terms

Interventions

Drug Therapy; Etoposide; Cisplatin

Intervention Hierarchy (Ancestors)

Therapeutics; 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

• Anhui Shi, Doctor

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 11, 2017
• Study Start: June 30, 2017
• Primary Completion: April 30, 2021
• Study Completion: January 30, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)