Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126828
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2005-08-03
Brief Title:
Study of Radiation Dose Intensity Concurrent With Chemotherapy For Limited Stage Small Cell Lung Cancer
Sponsor:
AHS Cancer Control Alberta
Organization:
AHS Cancer Control Alberta
Study Overview
Official Title:
A Phase III Study of Radiation Dose Intensity Concurrent With Chemotherapy For Limited Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients who have limited stage small cell lung cancer are presently treated with chemotherapy and radiation therapy RT Despite this aggressive treatment the vast majority of patients will have their cancer recur after treatment A recurrence is not curable at this time therefore efforts to reduce recurrence rates are desirable Due to the sensitivity of surrounding structures in the chest to radiation it has not been possible to give doses that can cure most tumours Three-dimensional conformal radiotherapy is a special form of radiation therapy that allows doctors to reduce the amount of radiation dose to normal tissues and therefore reduce toxicity and in turn let them safely increase the dose to tumours The purpose of this study is to determine whether the combination of three-dimensional conformal radiotherapy and chemotherapy will be a more effective treatment If the treatment is found to be safe for the first group of patients then the total radiation dose will be increased for the next group of patients who are treated on this study
Detailed Description:
Radiotherapy represents one of the primary treatment modalities for patients with limited stage small cell lung cancer SCLC With contemporary concurrent radiotherapy and chemotherapy approximately 20 of patients survive 5 years While distant metastases are common local intrathoracic failures are common as well occurring in 40 of treated patients Reducing local failure rates may lead to improved survival for these patients There appears a growing body of data which suggests a radiation dose response relationship for SCLC However the close proximity of critical normal structures such as the spinal cord and esophagus to the primary tumour limits the prescription dose in conventional radiotherapy Three Dimensional Conformal Radiotherapy 3DCRT offers the possibility of reducing normal tissue irradiation and hence reducing the treatment toxicity while maintaining the dose of radiation to the tumour Another strategy is accelerated fractionation which shortens the treatment time by allowing less opportunity for tumour cell repopulation The use of 3DCRT with larger radiation fraction size should maintain satisfactory treatment related toxicity while permitting the potential gains of accelerated fractionation and dose escalation In this study patients with limited stage SCLC who are eligible will be treated with a large field low dose radiotherapy followed by accelerated 3DCRT given concurrently with standard Cisplatin Etoposide chemotherapy
Primary Objective To determine the maximum tolerable dose of radiotherapy for SCLC
Secondary Objectives
1 To assess treatment toxicity
2 To assess quality of life and retention of pulmonary function
3 To assess progression-free survival on this regimen
Schema Eligible patients will receive 4 cycles of Cisplatin Etoposide chemotherapy Thoracic radiotherapy will be given concurrently starting with cycle 2 of chemotherapy Only one dose level will be open at a time Four dose levels are planned all delivered in 25 fractions once daily over 5 weeks
1 50 Gy 2 Gy per fraction
2 58 Gy
3 62 Gy
4 65 Gy Patients who achieve a complete response at the end of chemotherapy and thoracic radiotherapy will receive prophylactic cranial irradiation
Evaluation and Follow-up Patients will be assessed and evaluated at least weekly during radiation therapy Following treatment patients will be seen 1 month after the completion of treatment then every 3 months until 2 years then every 6 months Chest x-rays will be performed at each follow-up CT scan of chest and pulmonary function tests will be performed every 6 months for the first 2 years then yearly
Primary Objective To determine the maximum tolerable dose of radiotherapy for SCLC
Secondary Objectives
1 To assess treatment toxicity
2 To assess quality of life and retention of pulmonary function
3 To assess progression-free survival on this regimen
Schema Eligible patients will receive 4 cycles of Cisplatin Etoposide chemotherapy Thoracic radiotherapy will be given concurrently starting with cycle 2 of chemotherapy Only one dose level will be open at a time Four dose levels are planned all delivered in 25 fractions once daily over 5 weeks
1 50 Gy 2 Gy per fraction
2 58 Gy
3 62 Gy
4 65 Gy Patients who achieve a complete response at the end of chemotherapy and thoracic radiotherapy will receive prophylactic cranial irradiation
Evaluation and Follow-up Patients will be assessed and evaluated at least weekly during radiation therapy Following treatment patients will be seen 1 month after the completion of treatment then every 3 months until 2 years then every 6 months Chest x-rays will be performed at each follow-up CT scan of chest and pulmonary function tests will be performed every 6 months for the first 2 years then yearly
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PCRP-07 | None | None | None |