Status:
UNKNOWN
Hypofractionated vs. Conventionally Fractionated Concurrent CRT for Unresectable Stage III NSCLC
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Unresectable Stage III Non-small-cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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-...
Detailed Description
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 NS...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT03331575
Start Date
November 1 2017
End Date
November 1 2020
Last Update
November 6 2017
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China