Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized controlled non-inferior trial prospectively enrolled patients with limited-stage small cell lung cancer (LS-SCLC). Patients in the experimental group would receive radiotherapy with omission of the clinical target volume (CTV) for the primary tumor, while those in the control group would receive radiotherapy including CTV. The efficacy and toxicity of the two groups are compared to provide evidence for the radiotherapy of LS-SCLC. The target volume of LS-SCLC may be reduced by omitting CTV without increasing local recurrence but potentially reducing the dose to organs at risk and the side effects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Creating CTV for primary tumor. |
|
| Experimental group | Experimental | Omitting CTV for primary tumor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | Twice-daily (45 Gy/30 fractions) or once-daily (45 Gy/15 fractions) thoracic radiotherapy after 2-4 cycles of chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local progression free survival | From the date chemotherapy commenced to the first clinical or radiological evidence of progressive disease at the primary site or death, whichever occurs first, to be assessed up to 3 years | |
| Severe toxicity free survival | From the date chemotherapy commenced to the first record of serious adverse events related to radiotherapy, to be assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From the date chemotherapy commenced to the date of death from any cause or the end of follow-up at 3 years | |
| Progression free survival | From the date chemotherapy commenced to disease progression or death, whichever occurs first, to be assessed up to 3 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Chen | Contact | 86+02087343504 | chenming@sysucc.org.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D005047 | Etoposide |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Etoposide + carboplatin; Etoposide + cisplatin | Drug | Carboplatin IV (AUC=5) on day 1 combined with etoposide IV (100mg/m2) on days 1-3, or cisplatin IV (25mg/m2) on days 1-3 combined with etoposide IV (100mg/m2) on days 1-3. Treatment is repeated every 21 days for 4-6 cycles. |
|
| Creating CTV for primary tumor | Radiation | A margin of 0.8 cm beyond the gross target volume of primary tumor. |
|
| prophylactic cranial irradiation (PCI) | Radiation | Beginning 4-6 weeks after chemoradiotherapy completion, patients in both arms who achieve a complete or partial response without brain metastasis receive PCI at 25 Gy/10 fractions or 26 Gy/13 fractions, delivered once daily (5 days per week). |
|
| Number of participants with recurrence or metastasis as evaluated by RECIST 1.1 | From the date chemotherapy commenced to the end of follow-up at 3 years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From the date chemotherapy commenced to the end of follow-up at 3 years |
| Zhejiang Provincial Cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
|
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |