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Effects of Conccurent Radiotherapy Aimed at Primary Tumor on Survival of Lung Adenocarcinoma Patients with Malignat Pleural Effusion and Positive Driver Gene: a Phase II Randomized Controlled Trial

Effects of Conccurent Radiotherapy Aimed at Primary Tumor on Survival of Lung Adenocarcinoma Patients with Malignat Pleural Effusion and Positive Driver Gene: a Phase II Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032639
Enrollment
Unknown
Registered
2020-05-04
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-05-11

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

Conditions

Lung Adenocarcinoma

Interventions

experimental group:Conccurent radiotherapy aimed at primary tumor
control group:Maintain TKI targeted therapy

Sponsors

Huai'an First People's Hospital,Jiangsu Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Lung adenocarcinoma confirmed by histology or cytology Clinical stage are IVa according AJCC / UICC lung cancer stage (Eighth Edition) and drainage of pleural effusion confirmed the presence of tumor cells; 2. There are measurable lesions according to the RECIST standard; 3. There are positive driver gene and MPE were controlled effectively(CR;PR or SD) at least 2 months administrated by TKI; 4. Ages >= 25 years and = 100g / L, platelet >= 10 x 10^12 / L, neutrophil absolute count >= 1.5 x 10^9 / L; 9. Serum creatinine = 65 ml / min; 10. Serum bilirubin 0.8L; 14. Patients sign formal informed consent.

Exclusion criteria

Exclusion criteria: 1. Tumor with PD-L1 TPS of 50% or greater; 2. Without a sensitising EGFR mutation or ALK translocation; 3. Patients who underwent chest radiotherapy, chemotherapy or lung cancer surgery before the start of the trial; 4. With brain metastases, or patients with total lesions other than pleural effusion greater than three radiotherapy fields; 5. There are severe cardiovascular or pulmonary disease, interstitial pneumonia or previous history of interstitial pneumonia; 6. Patients who could not understand or follow the test requirements,or patients with mental disorders; 7. Patients with other malignant lesions except curable skin cancer (not melanoma), cervical carcinoma in situ or Malignant tumor cured for 5 years or more; 8. Patients with arrhythmias with NCI CTCAE 4.0 or higher, or patients with symptomatic bradycardia, or male with QTc> 450 msand female with QTc> 470 ms (QTc is calculated using Fridericia's correction formula QTc = QT / RR0.33); 9. With a history of cusp torsion or congenital QT prolongation syndrome; 10. Patients with a history of tip torsion or history of congenital; 11. QT prolongation syndrome. Patients with multiple factors affecting oral medications (eg, inability to swallow, chronic diarrhea, and intestinal obstruction, etc.); 12. Some obvious diseases that researchers believe should be excluded from this study.

Design outcomes

Primary

MeasureTime frame
Progress-free Survival;Toxicity;Failure Patterns;Quality of Life;

Secondary

MeasureTime frame
Overall Survival;

Countries

China

Contacts

Public ContactZhang Tiecheng

Huai'an First People's Hospital, Jiangsu Province

tiecheng_zhang@yahoo.com+86 13952383564

Outcome results

None listed

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