S-1 for elderly patients with locally advanced squamous cell carcinoma of the lung radiation sensitizing Observation of the clinical efficacy and safety study (SRIT-LC study)

S-1 for elderly patients with locally advanced(stage IIIA and IIIB) squamous cell carcinoma of the lung radiation sensitizing Observation of the clinical efficacy and safety study (SRIT-LC study)

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIN-16008205

Enrollment

Unknown

Registered

2016-04-01

Start date

2016-04-01

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

squamous cell carcinoma of the lung

Interventions

one arm:Concurrent radiotherapy with S1 regimen

Eligibility

Sex/Gender

All

Age

65 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Histological or cytological proof of squamous cell carcinoma; 2. Follow up AJCC 7, unresectable Stage IIIA or IIIB disease as evaluated by imaging within 28 days prior to registration for protocol therapy; 3. one Measurable disease per RECIST as evaluated by imaging within 28 days prior to registration for protocol therapy; 4. Aged > 65 years old; 5. No prior chemotherapy, adjuvant therapy or radiotherapy for lung cancer; 6. ECOG PS 0 or 1; 7. Hematopoietic: Platelets >=100 K/mm3 ,Absolute Neutrophil Count (ANC) >=2.0 K/mm3, HB>=8.0 g/dL; Hepatic: Total bilirubin =50 cc/min; 8. Patients can oral medication by mouth; 9. Normal EKG finding within 28 days prior to registration for protocol therapy; 10. To be able to understand and willingness to sign a written informed consent document; 11. Patients with other cancer with DFS more than 5 years, in situ cervical cancer, basal melanoma within 3 years as include.

Exclusion criteria

Exclusion criteria: 1. recent history of Pulmonary fibrosis or interstitial pneumonia within 28 days prior to registration for protocol therapy; 2. use of an chemotherapy or target therapy drug within 4 weeks preceding this study; 3. Severe diarrhoea; 4. Current or recent disease within infection; 5. Current or recent disease include (but not only) heart failure,renal failure, liver failure,bleeding ulcer, Intestinal palsy, intestinal obstruction or poor control of diabetes; 6. Moderate or severe ascites or pleural effusion required drainage; 7. psychiatric/cognitive or neurological impairment; 8. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.

Design outcomes

Primary

Measure	Time frame
Progression free survial;	—

Secondary

Measure	Time frame
tumor objective response rate;Overall Survial;quality of life;	—

Countries

China

Contacts

Public ContactGao Feng

Heilongjiang Land Reclamation Bureau General Hospital

15846614644@163.com+86 0451 55197906

Outcome results

None listed

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