A phase I/II study in patients with limited-stage small cell lung cancer treated with chemotherapy concurrently with accelerated 3-D conformal radiotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONC-13004856

Enrollment

Unknown

Registered

2013-07-31

Start date

2007-08-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

limited-stage small cell lung cancer

Interventions

therapeutic group:thoracic radiotherapy(55Gy/22Fx) +chemotherapy (EP: VP16 70mg/m2 IV D1-4

DDP 25mg/m2 IV D1-3, or 70-75mg/ m2 D1

or carboplatin, AUC 5 or 6, AUC=(mg/ml/min)×[CCr(ml/min)+25]

q21d 4-6 cycle)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Small cell lung cancer confirmed histologically or cytologically(repeat twice or the same result diagnosed by two pathologists) in our hospital pathology consultation; 2) Limited stage defined as disease confined to the ipsilateral hemithorax, which can be safely encompassed within a tolerable radiation field; 3) Aged between 18 years and 70 years; 4) ECOG PS 0-2; 5) Weight loss 6 months before radiotherapy =10%; 6) No serious medical problems; 7) FEV10.75Lor FEV1/FVC >0.7 (with or without bronchodilator) or after use bronchodilator: FEV1/FVC =0.7 , FEV1= 50% expected value; 8) Never treated with chest radiotherapy; 9) Without other primary tumor before treatment; 10) Not pregnancy or breastfeeding women; 11) Adequate hematologic parameters (leukocyte count greater than 4,000/mm3, granulocyte count greater than 2000/mm3, platelet count greater than 100,000/mm3 and hemoglobin level greater than 9 g/dL), adequate hepatic (serum bilirubin level less than 1.5 mg/dL, serum AST and ALT levels lower than 2.5 times of the upper limit of normal) and renal function (serum creatinine level lower than 2.5 mg/dL); 12) Signed the informed consent form; 13) Treatment planning of 3-D conformal radiotherapy: normal lung tissue: V20=25%, Dmean=15 Gyesophagus: Dmean=28 Gy, V55=25% spinal cord: Dmax =42 Gyheart: Dmean=25 Gy

Exclusion criteria

Exclusion criteria: 1) Disease progression during induction chemotherapy or radiotherapy; 2) Ocurrence of a second primary tumors during treatment; 3) Appear of not chemotherapy and/or radiotherapy related complications and the original treatment plan was unable to complete or radiotherapy gap is more than 7 days or above; 4) Death unrelated to therapeutic methods during treatment; 5) Patients request to terminate treatment; 6) All patients out of group should be discussed and be recorded.

Design outcomes

Primary

Measure	Time frame
2-year disease progression-free survial;	—

Secondary

Measure	Time frame
Response rate;2-year local control rate;2-year overall survival rate;	—

Countries

China

Contacts

Public ContactXiao-long Fu

Fudan University Shanghai Cancer Center

xlfu1964@hotmail.com+86 13651635103

Outcome results

None listed

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