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Comparison of hypofractionated helical tomotherapy (TOMO) concurrent chemoradiation therapy versus conventional intensity-modulated radiation therapy concurrent chemoradiation therapy for the driven gene negative stage IIIB non-small cell lung cancer: a randomized controlled trial

Comparison of hypofractionated helical tomotherapy (TOMO) concurrent chemoradiation therapy versus conventional intensity-modulated radiation therapy concurrent chemoradiation therapy for the driven gene negative stage IIIB non-small cell lung cancer: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019975
Enrollment
Unknown
Registered
2018-12-10
Start date
2019-01-01
Completion date
Unknown
Last updated
2019-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

Group 2:hypofractionated helical tomotherapy
Group 1:conventional intensity-modulated radiation therapy

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients should be diagnosed as NSCLC histologically or cytologically, driving genes negative tested by tissue and blood samples including EGFR/ALK/ROS1/MET/HER2/PIK3CA/BRAF/RET/Key; 2. Chest CT, cranial MRI, and CT/PET-CT should be performed and staging should be stage III B on the basis of UICC/AJCC 8th Edition TNM staging standard for lung cancer; 3. Aged 18-75 years old; 4. KPS scores = 70 or PS = 2; 5. The patient was initially treated, and no other anti-tumor treatment was received before enrollment. There was no pleural invasion and pleural effusion. Respiratory function compensation and heart, liver, kidney and other organs are normal; 6. patients have no history of chest radiotherapy; 7. patients can understand the situation of the study and has signed informed consent.

Exclusion criteria

Exclusion criteria: 1) patients have other malignant tumors at the same time, or the tumor-free survival time upper limit of normal value (ULN) 1.5 times, aspartate aminotransferase (AST), alanine aminotransferase (ALT) > ULN 2.5 times, serum creatinine > upper limit of normal value 1.5 times, and creatinine clearance rate < 60 ml/min; 8) patients use other experimental drugs or participation in other clinical trials simultaneous; 9) any other situation that the researcher considered patients are unsuitable for the trial.

Design outcomes

Primary

MeasureTime frame
3 year survival rates;

Secondary

MeasureTime frame
local control rates;progrseeion-free survival;Toxic side effects;

Countries

China

Contacts

Public ContactJian He

Zhongshan Hospital, Fudan University

hejian62@163.com+86 13386057161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026