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Health Condition(s) or Problem
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Lung Cancer
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Lay Summary
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This study aims to establish a standard chemo-therapy regimen for patients with limited stage Small Cell Lung Cancer (SCLC) and good performance status. (from UKCRN Portfolio)
Additional lay summaries...
http://www.cancerhelp.org.uk/trials/a-study-to-find-the-best-way-to-give-radiotherapy-for-people-with-small-cell-lung-cancer (from ISRCTN)
RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known
which schedule of radiation therapy is more effective when given together with chemotherapy
in treating small cell lung cancer.
PURPOSE: This randomized phase III trial is studying two different schedules of radiation
therapy to compare how well they work when given together with cisplatin and etoposide in
treating patients with limited stage small cell lung cancer.
(from ClinicalTrials.gov)
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Who can enter the trial
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DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer
- Limited stage disease that can be encompassed within a radical radiation portal
- No mixed small cell or non-small cell histologic features
- No more than 1 of the following adverse factors:
- Alkaline phosphatase > 1.5 times upper limit of normal
- Sodium < lower limit of normal
- No malignant pleural or pericardial effusions
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Creatinine normal
- Creatinine clearance = 50 mL/min
- FEV_1 > 1 L OR > 40% of predicted
- DLCO > 40% of predicted
- No other medical condition that would preclude study treatment
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior surgical resection of the primary tumor
- No prior radiotherapy for lung cancer
- No other prior or concurrent therapy that would preclude study treatment
- No concurrent epoetin alfa for anemia
- No concurrent sargramostim (GM-CSF)
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Who cannot enter the trial
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DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer
- Limited stage disease that can be encompassed within a radical radiation portal
- No mixed small cell or non-small cell histologic features
- No more than 1 of the following adverse factors:
- Alkaline phosphatase > 1.5 times upper limit of normal
- Sodium < lower limit of normal
- No malignant pleural or pericardial effusions
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Creatinine normal
- Creatinine clearance = 50 mL/min
- FEV_1 > 1 L OR > 40% of predicted
- DLCO > 40% of predicted
- No other medical condition that would preclude study treatment
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior surgical resection of the primary tumor
- No prior radiotherapy for lung cancer
- No other prior or concurrent therapy that would preclude study treatment
- No concurrent epoetin alfa for anemia
- No concurrent sargramostim (GM-CSF)
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What will happen
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Radiation; Once daily radiotherapy; Standard of care chemotherapy (cisplatin/etoposide) + once daily radiotherapy; Once daily radiotherapy; Twice daily radiotherapy; Radiation; Twice daily radiotherapy; Standard of care chemotherapy (cisplatin/etoposide) + twice daily radiotherapy; Once daily radiotherapy; Twice daily radiotherapy
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Primary aim
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Overall survival
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Secondary Aim
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Local progression-free survival; August 2015; No; Metastasis-free survival; August 2015; No; Toxicity; August 2015; Yes; Cytotoxic dose intensity; August 2015; Yes; Radiotherapy dose intensity; August 2015; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://cancer.gov/clinicaltrials/CHNT-CONVERT; http://www.converttrial.com
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Manchester
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