Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LS-SCLC
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|ClinicalTrials.gov Identifier: NCT02990780|
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : December 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|SCLC||Radiation: Conventionally fractionated concurrent chemo-radiotherapy Radiation: Accelerated hypofractionated concurrent chemo-radiotherapy||Phase 3|
Small-cell lung cancer accounts for approximately 13% of all lung cancers, and one-third of these patients present with limited stage SCLC at diagnosis. Currently the standard of care for LS-SCLC is concurrent chemotherapy and thoracic radiation therapy, with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy, which has yielded a median survival of 15 to 23 months and 5-year survival rate up to 26%.
The optimal dose/fraction for LS-SCLC remains debatable. For SCLC with the characteristic of rapid doubling time and high growth fraction, there is also evidence suggesting that prolonged or interrupted overall radiation time contributes to treatment failure and poor outcome because of accelerated repopulation.In our previous study we also found that overall radiation time might play an important role in the treatment of LS-SCLC and that patients treated with a high biologically effective dose (BED, including time factor) of >57 Gy have favorable local control and survival.
This is a randomised prospective phase III study based on patients with limited stage SCLC, defined as disease confined to one hemithorax and hilar,mediastinal, or supraclavicular nodes without pleural effusion, which can be safely encompassed within a tolerable radiation field. The purpose of this study is to add more information to the current medical literature about the efficacy and safety of accelerated hypofractionated vs. conventionally fractionated concurrent chemo-radiotherapy for limited-stage SCLC.
Patients will be randomized into two groups. The control group will undergo the induction chemotherapy followed by conventionally fractionated concurrent chemo-radiotherapy.The experimental group will receive induction chemotherapy followed by accelerated hypofractionated concurrent chemo-radiotherapy.The investigators compare overall survival (OS) of the two groups.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III Randomized Study of Induction Chemotherapy Followed By Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Stage Small Cell Lung Cancer.|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
Active Comparator: Conventionally fractionated CRT
Induction chemotherapy followed by conventionally fractionated concurrent chemo-radiotherapy,with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy.
Radiation: Conventionally fractionated concurrent chemo-radiotherapy
Experimental: Accelerated hypofractionated CRT
Induction chemotherapy followed by accelerated hypofractionated concurrent chemo-radiotherapy,with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy.
Radiation: Accelerated hypofractionated concurrent chemo-radiotherapy
- Overall Survival [ Time Frame: 2 years ]
- Progress Free Survival [ Time Frame: 2 years ]
- Treatment-related adverse event [ Time Frame: 1 years ]
- Locoregional recurrence-free survival [ Time Frame: 2 years ]
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): NCT02990780
|Contact: Xiaolong Fu, PhD||862122200000 ext email@example.com|
|Contact: Yiting Wang||862122200000 ext firstname.lastname@example.org|
|Shanghai Chest Hospital||Recruiting|
|Shanghai, Shanghai, China|
|Contact: Xiaolong Fu, PhD +862122200000 ext 3602 email@example.com|