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Hypofractionated vs. Conventionally Fractionated Concurrent CRT for Unresectable Stage III NSCLC

NCT ID: NCT03331575

Last Updated: 2017-11-06

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2020-11-30

Brief Summary

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This protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of hypofractionated vs. conventionally fractionated concurrent chemo-radiotherapy for unresectable stage III non-small-cell lung cancer

Detailed Description

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Hypofractionated radiotherapy (RT) delivers higher doses of RT over a shorter period of time and may kill more tumor cells and may have fewer side effects. Dose escalation in unresectable stage III NSCLC has been safely achieved up to LEVEL 3 (PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx). Acute toxicities were well tolerable. Further stage II clinical study has found that hypofractionated RT can significantly improve the efficacy of patients with a low toxicity profile. The aim of this study is to compared with hypofractionated and conventionally fractionated concurrent chemotherapy , and evaluate whether hypofractionated RT can improve local control and overall survival in unresectable stage III non-small-cell lung cancer (NSCLC).

Conditions

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Unresectable Stage III Non-small-cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Arm1(Hypofractionated Radiotherapy)

Hypofractionated Radiotherap（PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles )

Group Type EXPERIMENTAL

Arm1 (Hypofractionated radiotherapy)

Intervention Type RADIATION

hypofractionated RT（PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles )

Arms2（Conventional Radiotherapy）

Conventional Radiotherapy（PTV-G60Gy/30Fx,2Gy/Fx; PTV-C 50.4Gy/30Fx, 1.8Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles )

Group Type PLACEBO_COMPARATOR

Arm1 (Hypofractionated radiotherapy)

Intervention Type RADIATION

hypofractionated RT（PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles )

Interventions

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Arm1 (Hypofractionated radiotherapy)

hypofractionated RT（PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles )

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 18 years to 75 years

•.Histologically proven lung adenocarcinoma or squamous cell lung carcinoma of r Unresectable Stage III NSCLC(according to the TNM classification in theUnion for International Cancer Control (UICC) 7th ed.)
* No prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) treatment or other targeted therapy
* No prior thoracic RT
* No severe perioperative complications and expected postoperative lifespan

≥4 months
* ECOG Performance Status 0-1
* Voluntarily participated in this study and signed the informed consent form by himself or his agent. Had good compliance with the study procedures, and can cooperate with the relevant examination, treatment and follow-up

Exclusion Criteria

* Diagnosed with other prior or concurrent malignancies (neoplasm) except for basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
* Patients with any severe or uncontrolled systematic disease including severe cardiovascular, liver, kidney, hematopoietic, metabolic disease, or uncontrolled active infection that would preclude study participation
* Patients with positive mental disorder that would preclude study participation;
* Contradictory to chest radiotherapy
* Pregnant or nursing women
* Concurrent other anti-cancer treatment
* Prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) treatment or other targeted therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiaolong Fu

Xiaolong Fu

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaolong Fu, PhD

Role: CONTACT

Phone: 862122200000

Email: [email protected]

Qin Zhang, PhD

Role: CONTACT

Phone: 8618017321606

Email: [email protected]

Facility Contacts

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Xiaolong Fu, PhD

Role: primary

Qin Zhang, PhD

Role: backup

Other Identifiers

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SCHLC006

Identifier Type: -

Identifier Source: org_study_id