Clinical trial · Interventional
A Prospective Randomized Study Comparing the Target Volume for Limited-stage Small Cell Lung Cancer
Omitting Elective Nodal Irradiation and Irradiating Post-induction Versus Pre-induction Chemotherapy Tumor Extent for Limited-stage Small Cell Lung Cancer
NCT01731548CI-TRIAL-00009068unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We hypothesized that the local control for both arms were not statistically significant, when irradiation to the post-induction chemotherapy tumor volume is compared with irradiation to the pre-induction chemotherapy tumor volume.While elective nodal irradiation will be omitted for both arms.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma of Lung | Lung Carcinoma | ALIAS | 0.90 |
| Limited Stage | — | UNRESOLVED | — |
| Small Cell | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hyperfractionated radiation therapy for both arms | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- study arm
- description
- For patients who are randomized to study arm, (i.e. to irradiate the post-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the post-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm. Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles. Radiotherapy will be administered with cycle 3 chemotherapy(1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks)
- interventionNames
- Radiation: hyperfractionated radiation therapy for both arms
- type
- ACTIVE_COMPARATOR
- label
- control arm
- description
- For patients who are randomized to control arm, (i.e. to irradiate the pre-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the pre-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm. Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles. Radiotherapy will be administered with cycle 3 chemotherapy (1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients were eligible if they had histologic or cytologic verification of small cell lung cancer (SCLC) and were radiographically confirmed limited-stage * Patients with contralateral mediastinal and ipsilateral supraclavicular lymphadenopathy were also included. * The patients should be between 18 and 75 years old without previous thoracic radiotherapy, chemotherapy or biotherapy. * Karnofsky performance status was ≥ 80. * Forced expiratory volume at 1 second (FEV1) ≥ 1 L. * Had measurable or assessable disease. * Neutrophilic granulocyte ≥ 1.5×109/L, haemoglobin ≥ 100 g/L, platelet count ≥ 100×109/L. * Serum creatine and bilirubin \< 1.5 × the upper normal limit (UNL), aminotransferase \< 2 × UNL. * Weight loss was less than 10% within 6 months before diagnosis. * Written informed consent was required from all patients. Exclusion Criteria: * Patients were ineligible if they had a history of other malignant diseases except for non-melanomatous skin cancer and carcinoma in situ of the cervix, or any contraindications for chemoradiotherapy, malignant pleural and/or pericardial effusion.
References
Publications (1)
- DERIVEDYu TT, Hu X, Liufu WJ, Niu SQ, Lian HM, Ma HL, Wang J, Bao Y, Chen M, Peng F. Six versus four or five cycles of first-line etoposide and platinum-based chemotherapy combined with thoracic radiotherapy in patients with limited-stage small-cell lung cancer: A propensity score-matched analysis of a prospective randomized trial. Cancer Med. 2024 Apr;13(8):e7215. doi: 10.1002/cam4.7215. PMID 38659392