NCT00632853|UnknownPhase 3ResultsDMC

Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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5 other identifiers

CALGB-30610RTOG 0538U10CA031946CDR0000588879NCI-2009-00470

Study Type

interventional

Target

731

Locations

4 countries

Sites

934

Timeline

RegisteredMar 2008

StartedMar 2008

Brief Summary

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

731

participants targeted

Target at P75+ for phase_3 lung-cancer

Geographic Reach

4 countries

934 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed

7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2008

Completed

14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2022

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

June 12, 2023

Completed

Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

14 years

First QC Date

March 8, 2008

Results QC Date

April 28, 2023

Last Update Submit

June 8, 2023

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

Overall Survival Time
Overall survival time is defined as the time between a patient's registration and death or end of survival follow up.
11.25 years

Secondary Outcomes (9)

Complete and Partial Response Rates
11.25 years
Failure-free >> Survival
Up to 5 years
To Compare Rates of Local Relapse, Distant Metastases and Brain Metastases With These > Regimens.
5 years
To Compare Patients' Quality of Life Between These Treatment Regimens in Terms of Their > Physical Symptoms, Physical Functioning and Psychological State.
5 years
To Describe the Patterns of Use of Thoracic Intensity Modulated Radiation Therapy (IMRT) in Patients With Limited Stage Small Cell Lung Cancer.
5 years
+4 more secondary outcomes

Study Arms (2)

Arm A - Standard Radiotherapy + Chemotherapy

ACTIVE COMPARATOR

Radiotherapy (every day, Monday-Friday, for a total of 3 weeks) XRT: 45 Gy BID (1.5 Gy/fx) starting on day 1 of Cycle 1 or 2, every day, for 3 weeks Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks): * Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days * Etoposide 100 mg/m2 IV Register/ on days 1, 2, and 3, every 21 days

Radiation: Standard Radiation Dose TherapyDrug: cisplatinDrug: etoposideDrug: carboplatin

Arm B - High Dose Radiotherapy + Chemotherapy

EXPERIMENTAL

Radiotherapy (every day, Monday-Friday, for a total of 7 weeks) XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks): * Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days * Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days

Drug: cisplatinDrug: etoposideRadiation: High Radiation Dose TherapyDrug: carboplatin

Interventions

Standard Radiation Dose TherapyRADIATION

45 Gy

Arm A - Standard Radiotherapy + Chemotherapy

cisplatinDRUG

Arm A - Standard Radiotherapy + ChemotherapyArm B - High Dose Radiotherapy + Chemotherapy

etoposideDRUG

Arm A - Standard Radiotherapy + ChemotherapyArm B - High Dose Radiotherapy + Chemotherapy

High Radiation Dose TherapyRADIATION

70 Gy

Arm B - High Dose Radiotherapy + Chemotherapy

carboplatinDRUG

Arm A - Standard Radiotherapy + ChemotherapyArm B - High Dose Radiotherapy + Chemotherapy

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

1. Documentation of Disease 1. Histologically or cytologically documented small cell lung cancer (SCLC) 2. Limited-stage disease patients with disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes * Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes are not eligible * Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not are not eligible unless they have a negative thoracentesis * Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray are not eligible 2. Measurable disease - Patients must have measurable disease, which includes lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques OR ≥ 1 cm by spiral CT scan 3. Prior Treatment 1. Patients may have received one and only one cycle of chemotherapy prior to enrolling on CALGB 30610, which must have included carboplatin or cisplatin and etoposide. 2. If a patient has had one cycle of cisplatin or carboplatin/etoposide prior to registration, the patient must have had all of it prior to registration tests as outlined in the protocol and prior to starting their first cycle of chemotherapy. 3. Additionally, these patients also must have met all of the eligibility criteria in the protocol prior to receiving the first cycle of chemotherapy. 4. Registration to CALGB 30610 must take place within 14-21 days after the start of the non-protocol therapy. 5. Failing to do all of the above will make the patient NOT eligible for CALGB 30610. 6. No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for SCLC 7. No prior mediastinal or thoracic radiotherapy 8. Patients with complete surgical resection of disease are not eligible 4. Age Requirement ≥ 18 years of age 5. ECOG Performance Status 0-2 6. Non-pregnant and non-nursing - No patients that are known to be pregnant or nursing 7. Required Initial Laboratory Values 1. Granulocytes ≥ 1,500/µl 2. Platelet count ≥ 100,000/µl 3. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) 4. AST (SGOT) ≤ 2.0 times ULN 5. Serum creatinine ≤ 1.5 times ULN OR Calculated creatinine clearance ≥ 70 mL/min

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (934)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

The Kirklin Clinic at Acton Road

Birmingham, Alabama, 35243, United States

Location

Providence Hospital

Mobile, Alabama, 36608, United States

Location

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC