Clinical trial NCT03214003: Twice-daily SIB Radiotherapy Versus Standard Radiotherapy for Patients With SCLC
Official title: Twice-daily Radiotherapy by Simultaneous Integrated Boosting Technique Versus Twice-daily Standard Radiotherapy for Patients With Limited-stage Small Cell Lung Cancer: a Multicenter, Randomized, Controlled, Phase III Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Small Cell Lung Cancer Limited Stage
Radiotherapy
Keywords: small cell lung cancer limited stage
twice-daily radiotherapy
simultaneous integrated boosting technique
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: Fudan University
name: Xijing Hospital
name: Henan Cancer Hospital
name: Jilin Provincial Tumor Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Air Force General Hospital of the PLA
name: China-Japan Friendship Hospital
name: Peking University Third Hospital
name: Peking Union Medical College Hospital
name: Beijing Hospital
name: Beijing Chao Yang Hospital
name: Peking University People's Hospital
name: Peking University First Hospital
First posted: 2017-07-11
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Three hundred and twenty-six patients with a histological or cytological proven diagnosis of SCLC will be recruited from 35 centers in 14 areas including provinces, municipalities and autonomous region, from May 2017 to May 2020.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Local Progression Free Survival
timeFrame: 5 years
measure: Metastasis Free Survival
timeFrame: 5 years
measure: health related quality of life
timeFrame: 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.
measure: acute and late toxicity
timeFrame: 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.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Anhui Shi, Doctor
role: PRINCIPAL_INVESTIGATOR
References: