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A prospective single arm, multicenter phase II study of simultaneous integrated boost intensity-modulated radiation therapy combined with synchronous chemotherapy for limited-disease small cell lung cancer

A prospective single arm, multicenter phase II study of simultaneous integrated boost intensity-modulated radiation therapy combined with synchronous chemotherapy for limited-disease small cell lung cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053931
Enrollment
Unknown
Registered
2021-12-02
Start date
2015-09-01
Completion date
Unknown
Last updated
2022-10-31

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

Conditions

small cell lung cancer

Interventions

Experimental group:Synchronous boost accelerated hyperfractionated intensity-modulated radiation therapy combined with concurrent chemotherapy

Sponsors

The First Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed small cell carcinoma; 2. Aged 18 to 75 years, KPS score >= 80, weight loss within half a year = 1 cm or increased metabolism on PET-CT to consider metastatic lymph nodes); 4. No history of other anti-tumor diseases in the past, no progress in the efficacy evaluation after 2 cycles of EP/EC chemotherapy; Forced expiratory volume in 5.1 seconds (FEV1 >= 1L), neutrophil count >= 1.5 x 10^9/L, hemoglobin >= 100g/L, platelet count >= 100 x 10^9/L, serum creatinine and bilirubin<= 1.5 times the upper limit of normal, AST and ALT <= 2.5 times the upper limit of normal; 6. Fully understand this study, have the ability to complete the treatment, have the conditions for follow-up and voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. History of malignant tumors in other parts (previous or concurrent), excluding curable non-melanoma skin cancer and cervical carcinoma in situ; 2. Uncontrolled heart disease or myocardial infarction within the past 6 months; 3. Patients with a history of mental illness; 4. Pregnancy and lactation patients; 5. Uncontrolled diabetes and hypertension; 6. Interstitial pneumonia or active pulmonary fibrosis; 7. Active infection; 8. Others in charge of doctors think that they are not suitable for inclusion in the group.

Design outcomes

Primary

MeasureTime frame
local-regional control;

Secondary

MeasureTime frame
overall survival;Progression-free survival;distant metastasis free survival;Toxic and side effects;

Countries

China

Contacts

Public ContactBao Yong

The First Affiliated Hospital of Sun Yat-Sen University

pengfang220@163.com+86 20 87338692

Outcome results

None listed

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