Trial record 1 of 1 for:
NCT00632853
Three Different Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide
This study is currently recruiting participants.
Verified June 2013 by Alliance for Clinical Oncology Trials
Sponsor:
Cancer and Leukemia Group B
Collaborators:
Radiation Therapy Oncology Group
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Southwestern Oncology Group (SWOG)
Information provided by (Responsible Party):
Alliance for Clinical Oncology Trials ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier:
NCT00632853
First received: March 8, 2008
Last updated: June 14, 2013
Last verified: June 2013
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Purpose
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy Drug: cisplatin Drug: etoposide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide |
Resource links provided by NLM:
Further study details as provided by Alliance for Clinical Oncology Trials:
Primary Outcome Measures:
- Overall survival time between 3 treatment arms [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity [ Time Frame: Up to Interim Analysis ] [ Designated as safety issue: Yes ]
- Complete and partial response rates [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- Failure-free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- Local tumor progression according to RECIST criteria [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- Rates of distant metastases and intracranial metastases [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 729 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | June 2023 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients undergo standard-dose (45 Gy given) thoracic radiotherapy twice daily, every day, for 3 weeks. Chemotherapy (cisplatin and etoposide) will be administered at specific time points every 21 days for 4 cycles for a total of 12 weeks.
|
Radiation: 3-dimensional conformal radiation therapy
Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13)
Radiation: intensity-modulated radiation therapy
Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13)
Drug: cisplatin
80 mg/m2 by intravenous (IV) on day 1 of each 21 day cycle. Protocol therapy consists of 4 cycles of cisplatin administered every 21 days.
Drug: etoposide
100 mg/m2 by IV on days 1, 2 and 3 of each 21 day cycle. Protocol therapy consists of a total of 4 cycles of etoposide.
|
|
Experimental: Arm II
Patients undergo higher-dose (70 Gy) thoracic radiotherapy once daily, every day, for 7 weeks. Chemotherapy (cisplatin and etoposide) will be administered at specific time points every 21 days for 4 cycles for a total of 12 weeks.
|
Radiation: 3-dimensional conformal radiation therapy
Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13)
Radiation: intensity-modulated radiation therapy
Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13)
Drug: cisplatin
80 mg/m2 by intravenous (IV) on day 1 of each 21 day cycle. Protocol therapy consists of 4 cycles of cisplatin administered every 21 days.
Drug: etoposide
100 mg/m2 by IV on days 1, 2 and 3 of each 21 day cycle. Protocol therapy consists of a total of 4 cycles of etoposide.
|
|
Experimental: Arm III
(discontinued as of 03/10/13) Patients undergo higher-dose (61.2 Gy) thoracic radiotherapy once daily, 5 days a week, during the initial 16 days of treatment and then twice daily for 9 days of treatment.Chemotherapy (cisplatin and etoposide) will be administered at specific time points every 21 days for 4 cycles for a total of 12 weeks.
|
Radiation: 3-dimensional conformal radiation therapy
Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13)
Radiation: intensity-modulated radiation therapy
Given at 1 of 2 doses on one of two different schedules (Arm III discontinued as of 01/15/13)
Drug: cisplatin
80 mg/m2 by intravenous (IV) on day 1 of each 21 day cycle. Protocol therapy consists of 4 cycles of cisplatin administered every 21 days.
Drug: etoposide
100 mg/m2 by IV on days 1, 2 and 3 of each 21 day cycle. Protocol therapy consists of a total of 4 cycles of etoposide.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically documented small cell lung cancer (SCLC)
Limited-stage disease
- Disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes
The following patients are not eligible:
- Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes
- Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not
- Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray
- Measurable disease, defined as at least one unidimensionally measurable lesion ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Granulocytes ≥ 1,500/µl
- Platelet count ≥ 100,000/µl
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 2.0 times ULN
- Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 70 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Patients may have received one and only one course of chemotherapy prior to enrolling on CALGB 30610, which must have included cisplatin and etoposide
- If a patient has had one course of cisplatin/etoposide prior to registration, the patient must have had all of the prior-to-registration tests prior to starting their first course of chemotherapy
- Registration to CALGB-30610 must take place within 14-21 days after the start of the non-protocol therapy; failing to do all of the above will make the patient NOT eligible for CALGB-30610
- No prior radiotherapy or chemotherapy (except for the chemotherapy described above) for SCLC
- No prior mediastinal or thoracic radiotherapy
- No prior complete surgical resection of SCLC
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632853
Show 395 Study Locations
Show 395 Study LocationsSponsors and Collaborators
Cancer and Leukemia Group B
Radiation Therapy Oncology Group
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Southwestern Oncology Group (SWOG)
Investigators
| Study Chair: | Jeffrey A. Bogart, MD | State University of New York - Upstate Medical University |
| Study Chair: | Gregory A. Masters, MD | Helen F. Graham Cancer Center at Christiana Hospital |
| Study Chair: | Ritsuko U. Komaki, MD, FACR | M.D. Anderson Cancer Center |
| Study Chair: | John Heymach, MD, PhD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Alliance for Clinical Oncology Trials ( Cancer and Leukemia Group B ) |
| ClinicalTrials.gov Identifier: | NCT00632853 History of Changes |
| Other Study ID Numbers: | CDR0000588879, CALGB-30610, RTOG 0538, U10CA031946 |
| Study First Received: | March 8, 2008 |
| Last Updated: | June 14, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Alliance for Clinical Oncology Trials:
|
limited stage small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Etoposide phosphate Cisplatin Etoposide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 18, 2013