Clinical trial · Interventional
Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC
Phase III Randomized Study of Hypofractionated vs Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Disease Small Cell Lung Cancer
NCT02688036CI-TRIAL-00113011completedPhase 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)
The purpose of this study is to determine whether hypofractionated concurrent chemo-radiotherapy has the same efficiency as conventionally fractionated concurrent chemo-radiotherapy in Limited Disease Small Cell Lung Cancer.
Conditions
Conditions (2)
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, Small Cell | Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventionally fractionated concurrent chemoradiotherapy | Radiation | — | UNRESOLVED |
| hypofractionated concurrent chemoradiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- hypofractionated CRT
- description
- hypofractionated concurrent chemoradiotherapy
- interventionNames
- Radiation: hypofractionated concurrent chemoradiotherapy
- type
- ACTIVE_COMPARATOR
- label
- conventionally fractionated CRT
- description
- conventionally fractionated concurrent chemoradiotherapy
- interventionNames
- Radiation: conventionally fractionated concurrent chemoradiotherapy
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18\~70 years old, ECOG 0-2 * patients with histologically or cytologically proved small cell lung cancer * Limited disease (LD), was characterized by tumors confined to one hemithorax. It may include ipsilateral hilar, both mediastinum and both supraclavicular nodes. Metastatic lymph nodes were defined as lymph nodes with short diameter of more than 1cm or FDG uptake in PET. The thickness of pleural effusion was less than 1cm unless malignant pleural effusion was cytologically proved. In a word, stage I-IIIB excluding the patients with lung metastases should be defined as LD according to AJCC cancer staging 7th edition. * No progression after 2 cycles of chemotherapy with EP. * No prior history of anti-tumor treatment. * No severe internal diseases and no organ dysfunction * Written informed consent provided and Exclusion Criteria: * Malignant tumors of other sites. Non melanoma skin cancer and Cervical carcinoma in situ were not included if curable. * Active heart disease or acute myocardial infarction happen in six months. * Psychiatric history. * Pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG) * Uncontrolled diabetes or hypertension * Interstitial pneumonia or Active pulmonary fibrosis * Acute bacterial or fungal infection * Oral or intravenous use of steroids
References
Publications (34)
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- BACKGROUNDPignon JP, Arriagada R, Ihde DC, Johnson DH, Perry MC, Souhami RL, Brodin O, Joss RA, Kies MS, Lebeau B, et al. A meta-analysis of thoracic radiotherapy for small-cell lung cancer. N Engl J Med. 1992 Dec 3;327(23):1618-24. doi: 10.1056/NEJM199212033272302. PMID 1331787
- BACKGROUNDWarde P, Payne D. Does thoracic irradiation improve survival and local control in limited-stage small-cell carcinoma of the lung? A meta-analysis. J Clin Oncol. 1992 Jun;10(6):890-5. doi: 10.1200/JCO.1992.10.6.890. PMID 1316951
- BACKGROUNDMurray N, Coy P, Pater JL, Hodson I, Arnold A, Zee BC, Payne D, Kostashuk EC, Evans WK, Dixon P, et al. Importance of timing for thoracic irradiation in the combined modality treatment of limited-stage small-cell lung cancer. The National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 1993 Feb;11(2):336-44. doi: 10.1200/JCO.1993.11.2.336. PMID 8381164
- BACKGROUNDJeremic B, Shibamoto Y, Acimovic L, Milisavljevic S. Initial versus delayed accelerated hyperfractionated radiation therapy and concurrent chemotherapy in limited small-cell lung cancer: a randomized study. J Clin Oncol. 1997 Mar;15(3):893-900. doi: 10.1200/JCO.1997.15.3.893. PMID 9060525
- BACKGROUNDTakada M, Fukuoka M, Kawahara M, Sugiura T, Yokoyama A, Yokota S, Nishiwaki Y, Watanabe K, Noda K, Tamura T, Fukuda H, Saijo N. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with cisplatin and etoposide for limited-stage small-cell lung cancer: results of the Japan Clinical Oncology Group Study 9104. J Clin Oncol. 2002 Jul 15;20(14):3054-60. doi: 10.1200/JCO.2002.12.071.