A Phase 2 interventional study of Cisplatin and Etoposide in Lung Cancer, sponsored by Radiation Therapy Oncology Group. Completed at 104 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-22.
Sponsored by Radiation Therapy Oncology Group · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together with radiation therapy works in treating patients with limited-stage small cell lung cancer.
OBJECTIVES:
OUTLINE: Patients undergo radiotherapy once daily 5 days a week for approximately 3 weeks and then twice daily 5 days a week for approximately 2 weeks (a total of 9 treatment days during the final 2-week treatment period). Beginning on the first day of radiotherapy, patients receive cisplatin IV over 2 hours and etoposide IV over 1 hour on day 1 and oral etoposide once daily on days 2 and 3. Chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 18 months.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Radiation Therapy Oncology Group is the lead sponsor of 154 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Must have limited disease
Stage I, II, IIIA, or IIIB
Confined to 1 hemithorax, but excluding the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Drug: Cisplatin · Drug: Etoposide · Radiation: Radiation therapy
60 mg/m2 given intravenously. During RT, give on day 1 and day 22. After completion of RT, on days 43 and 64.
120 mg/m2 given intravenously. During RT, give on days 1-3, then days 22-24. After completion of RT, on days 43-45 and days 64-66.
Large field 28.8 Gy: 1.8 Gy per fraction, 5 days per week for 16 fractions. On days 23-26, BID: use anteroposterior and posteroanterior (AP/PA) fields in a.m. at 1.8 Gy per fraction; boost with 2nd treatment in p.m. at 1.8 Gy per fraction. Then off-cord boost, 1.8 Gy, BID, x last 5 days for a total dose of 61.2 Gy in 5 wks.
Overall Survival at 2 Years
Survival time is defined as time from study registration to the date of death from any cause and survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Time frame: From registration to 2 years
Overall Survival (OS) and Progression-free Survival (PFS) at 1 Year
An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method.
Time frame: From registration to one year.
Median Overall Survival Time and Progression-free Survival Time
An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method.
Time frame: From registration to 2 years
Number of Patients With Acute Treatment-related Grade 3 or 4 Esophagitis
Highest grade treatment-related toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening or disabling, Grade 5= Death related to toxicity.
Time frame: From start of radiation therapy until 90 days following the start of radiation therapy
Frequency of Treatment-related Fatalities at 2 Years
A treatment-related fatality was any death judged to be related to protocol treatment.
Time frame: From the start of treatment to 2 years
Tumor Response
Response will be recorded as the best response observed two months after the completion of chemoradiation therapy. Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions as measured by MRI, CT, or physical examination (this is the order of preference for measurement). Partial Response (PR): \>= 30% decrease in the sum of the longest diameter (LD) of target lesions (order of preference for measurement is MRI, CT, physical examination). Progressive Disease (PD): \>= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (order of preference for measurement is MRI, CT, physical examination). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time frame: From the start of treatment to 2 months following the completion of chemotherapy
| Milestone | Radiation Therapy + Chemotherapy |
|---|---|
| Started | 72 |
| Completed | 71 |
| Not completed | 1 |
| Withdrew: No protocol treatment received | 1 |
Survival time is defined as time from study registration to the date of death from any cause and survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
| percentage of participants | Radiation Therapy + Chemotherapy |
|---|---|
| Overall Survival at 2 Years | 36.60 (25.60 to 47.70) |
An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method.
| percentage of participants | Radiation Therapy + Chemotherapy |
|---|---|
| Overall Survival | 77.5 (65.9 to 85.5) |
| Progression-free Survival | 42.3 (30.7 to 53.4) |
An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method.
| months | Radiation Therapy + Chemotherapy |
|---|---|
| Overall Survival | 19.0 (16.7 to 21.7) |
| Progression-free Survival | 9.9 (7.9 to 12.4) |
Highest grade treatment-related toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening or disabling, Grade 5= Death related to toxicity.
| Participants | Radiation Therapy + Chemotherapy |
|---|---|
| Number of Patients With Acute Treatment-related Grade 3 or 4 Esophagitis | 13 |
A treatment-related fatality was any death judged to be related to protocol treatment.
| Participants | Radiation Therapy + Chemotherapy |
|---|---|
| Frequency of Treatment-related Fatalities at 2 Years | 2 |
Response will be recorded as the best response observed two months after the completion of chemoradiation therapy. Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions as measured by MRI, CT, or physical examination (this is the order of preference for measurement). Partial Response (PR): \>= 30% decrease in the sum of the longest diameter (LD) of target lesions (order of preference for measurement is MRI, CT, physical examination). Progressive Disease (PD): \>= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (order of preference for measurement is MRI, CT, physical examination). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
| Participants | Radiation Therapy + Chemotherapy |
|---|---|
| Complete Response | 29 |
| Partial Response | 28 |
| Stable Disease | 7 |
| Progressive Disease | 4 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Radiation Therapy + Chemotherapy | — | 67/71 (94.4%) | 71/71 (100%) |
| Event | Radiation Therapy + Chemotherapy |
|---|---|
| Neutrophils/granulocytes (ANC/AGC)Investigations | 56/71 |
| Leukocytes (total WBC)Investigations | 53/71 |
| Hemoglobin (Hgb)Blood and lymphatic system disorders | 18/71 |
| Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infeBlood and lymphatic system disorders | 14/71 |
| NauseaGastrointestinal disorders | 14/71 |
| VomitingGastrointestinal disorders | 12/71 |
| HyponatremiaMetabolism and nutrition disorders | 9/71 |
| DehydrationMetabolism and nutrition disorders | 8/71 |
| HypokalemiaMetabolism and nutrition disorders | 8/71 |
| Dysphagia, esophagitis, odynophagia (painful swallowing)Gastrointestinal disorders | 7/71 |
| Event | Radiation Therapy + Chemotherapy |
|---|---|
| Fatigue (lethargy, malaise, asthenia)General disorders | 55/71 |
| Hemoglobin (Hgb)Blood and lymphatic system disorders | 48/71 |
| PlateletsInvestigations | 48/71 |
| NauseaGastrointestinal disorders | 38/71 |
| Late RT Toxicity: Lung: NOSRespiratory, thoracic and mediastinal disorders | 37/71 |
| AnorexiaMetabolism and nutrition disorders | 33/71 |
| AlopeciaSkin and subcutaneous tissue disorders | 30/71 |
| Dysphagia, esophagitis, odynophagia (painful swallowing)Gastrointestinal disorders | 25/71 |
| Dysphagia-esophageal related to radiationGastrointestinal disorders | 24/71 |
| VomitingGastrointestinal disorders | 24/71 |
Eligible patients who started protocol treatment.
| Age, Continuous(years) | Radiation Therapy + Chemotherapy |
|---|---|
| Median | 71 (43 to 84) |
| Sex: Female, Male(Participants) | Radiation Therapy + Chemotherapy |
|---|---|
| Female | 34 |
| Male | 37 |
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