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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2023-01-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Small Cell Lung Cancer Limited Stage Radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SIB group

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).

Group Type EXPERIMENTAL

SIB

Intervention Type RADIATION

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

BID group

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).

Group Type ACTIVE_COMPARATOR

Standard

Intervention Type RADIATION

patients will recieve standard twice-daily radiotherapy concurrent with chemotherapy

Interventions

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SIB

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

Intervention Type RADIATION

Standard

patients will recieve standard twice-daily radiotherapy concurrent with chemotherapy

Intervention Type RADIATION

Other Intervention Names

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chemotherapy with etoposide and cisplatin chemotherapy with etoposide and cisplatin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No