Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
This study is currently recruiting participants.
Verified October 2011 by International Atomic Energy Agency
Sponsor:
International Atomic Energy Agency
Information provided by (Responsible Party):
International Atomic Energy Agency
ClinicalTrials.gov Identifier:
NCT00864331
First received: March 17, 2009
Last updated: October 12, 2011
Last verified: October 2011
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Purpose
Primary objectives of the study are:
To assess the differences in survival of the two treatment options in both stage III (A and B) nonsmall cell lung cancer (NSCLC) (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), respectively
Secondary objectives are:
To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), and To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Radiation: radiation Other: Chemotherapy and radiotherapy Drug: Chemotherapy Other: Palliative radiotherapy and chemotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy |
Resource links provided by NLM:
Further study details as provided by International Atomic Energy Agency:
Primary Outcome Measures:
- Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Radiotherapy
For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy.
|
Radiation: radiation
39 Gy in 13 daily fractions of 3 Gy
|
|
Experimental: Chemotherapy and radiotherapy
For patients in Group A (either stage IIIA or IIIB) receive a course of up to 3 cycles of chemotherapy followed by EBRT of 10 Gy in a single fraction or 16 Gy in 2 fractions 1 week apart.
|
Other: Chemotherapy and radiotherapy
Chemotherapy followed by low dose palliative radiotherapy
|
|
Active Comparator: Chemotherapy
For patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy.
|
Drug: Chemotherapy
Chemotherapy given alone
|
|
Experimental: Palliative radiotherapy and chemotherapy
For patients in Group B (either stage IIIB (wet) or IV) receive EBRT of 10 Gy in a single fraction or 16 Gy in two fractions 1 week apart, followed by up to 3 cycles of chemotherapy.
|
Other: Palliative radiotherapy and chemotherapy
Low dose palliative radiotherapy followed by chemotherapy
|
Detailed Description:
To compare survival rates (median and 1-year), and toxicity of two treatment regimens in patients with locally advanced incurable NSCLC (study A), to compare survival rates (median and 1-year) of two treatment regimens in patients with locally advanced and metastatic NSCLC (study B)
To compare HRQoL and cost effectiveness of two treatment regimens in patients with locally advanced incurable NSCLC (study A), and in patients with locally advanced and metastatic NSCLC (study B) and to evaluate the effect of HRQoL assessment on QoL dimensions
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Study A Inclusion Criteria:
- Histologically or cytologically confirmed NSCLC
- Stage IIIA/IIIB staged with
- CT chest and upper abdomen
- Liver, renal, hematological reserve appropriate (according to "standard" institutional values)
- Brain CT and/or bone scan only if clinical symptoms request such investigation
- Performance status KPS 60-90
- No second cancer except skin non-melanoma
- No previous treatment
- Patient must be contactable for follow-up
- Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)
- Life expectancy > 3 months
- Patient must be able and willing to give informed consent, and fill in questionnaires
Study A Exclusion Criteria:
- Stage III B "wet" (existing pleural effusion , but not necessarily cytologically verified)
- RT field > 200 cm2
- Pregnancy
Study B Inclusion Criteria:
- KPS 60-90
- Stage IV and Stage III B (existing pleural effusions , but not necessarily cytologically verified)
- Histologically or cytologically confirmed
- CT staged disease (thorax and possible upper abdomen)
- No second cancer except skin non-melanoma
- Liver, renal, haematological reserve appropriate (according to "standard" institutional values)
- No previous treatment
- Patient must be contactable for follow-up
- Patient must be able and willing to give informed consent and fill in questionnaires
- Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)
- Life expectancy > 3 months
Study B Exclusion Criteria:
- Brain metastasis (brain CT and/or MRI not needed, unless symptoms exist - clinically indicated)
- RT field > 200 cm2
- Pregnancy
- A-P separation too large to be adequately treated with 60-Co (?)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864331
Contacts
| Contact: Branislav Jeremic, MD | +43 1 2600 ext 21666 | B.Jeremic@iaea.org |
Locations
| Chile | |
| Instituto de Radiomedicine | Not yet recruiting |
| Santiago, Chile | |
| Contact: Mario Baeza, MD 00 562 2062400 mbaeza@rdc.cl | |
| Principal Investigator: Mario Baeza, MD | |
| China | |
| Affiliated Hospital of Ning Xia Medical College, Department of Radiation Oncology | Not yet recruiting |
| Yinchuan, China | |
| Contact: Hong Zhe, MD jessiedz2001@yahoo.com | |
| Principal Investigator: Hong Zhe, MD | |
| Croatia | |
| University of Zagreb Faculty of Medicine | Recruiting |
| Zagreb, Croatia | |
| Contact: Ana Frobe, MD afrobe@rudjer.irb.hr | |
| Principal Investigator: Ana Frobe, MD | |
| Egypt | |
| Misr Oncology Center (MOC) | Recruiting |
| Cairo, Egypt | |
| Contact: Aly Azmy, MD 00202 241 84024 alyaazmy68@hotmail.com | |
| Principal Investigator: Aly Azmy, MD | |
| India | |
| Tata Memorial Centre (TMC) Department of Atomic Energy (DAE) | Recruiting |
| Mumbai, India | |
| Contact: Jai P Agarwal, MD 0091 22 24177164 agarwaljp@tmc.gov.in | |
| Principal Investigator: Jai P Agarwal, MD | |
| Malaysia | |
| General Hospital Kuala Lumpur, Institute of Radiotherapy and Oncology | Not yet recruiting |
| Kuala Lumpur, Malaysia | |
| Contact: Fen N Lau, MD 00603 26905816 fenneelau@hotmail.com | |
| Principal Investigator: Fen Nee Lau, MD | |
| Malta | |
| Sir Paul Boffa Hospital | Recruiting |
| Floriana, Malta | |
| Contact: Stephen Brincat, MD 00356 21226691 stephen.brincat@gov.mt | |
| Principal Investigator: Stephen Brincat, MD | |
| Morocco | |
| Ministère de la Santé, Institut National d'Oncologie Sidi Mohamed Ben Abdellah | Not yet recruiting |
| Rabat, Morocco | |
| Contact: Tayeb Kebdani, MD kebdani2000@yahoo.fr | |
| Principal Investigator: Tayeb Kebdani, MD | |
| Pakistan | |
| Nuclear Medicine Oncology and Radiotherapy Institute | Recruiting |
| Islamabad, Pakistan | |
| Contact: Mohammad Faheem, MD 0092 51 9260611 nori@ntc.net.pk | |
| Principal Investigator: Mohammad Faheem, MD | |
| Panama | |
| Instituto Oncológico National | Not yet recruiting |
| Panama City, Panama | |
| Contact: Ricardo Britton, MD ricardobritton@hotmail.com | |
| Principal Investigator: Ricardo Britton, MD | |
| Peru | |
| Instituto Nacional de Enfermadades Neoplasicas Depto. De Radioterapia | Not yet recruiting |
| Lima, Peru | |
| Contact: Adela H Zelaya, MD 0051 1 2249305 adelahz@yahoo.com | |
| Principal Investigator: Adela H Zelaya, MD | |
| South Africa | |
| University of Witwatersrand Johannesburg Hospital Dept of Radiation Oncology | Recruiting |
| Johannesburg, South Africa | |
| Contact: Vinay Sharma, MD 0027 11 4812137 vinay.sharma@wits.ac.za | |
| Principal Investigator: Vinay Sharma, MD | |
| Tunisia | |
| Institut de la Sante Publique, Institut National de Cancer Salah Azaiz | Recruiting |
| Tunis, Tunisia | |
| Contact: Chiraz Nasr B Ammar, MD 00216 71 577818 chiraz_ammar@yahoo.fr | |
| Principal Investigator: Chiraz NB Ammar, MD | |
Sponsors and Collaborators
International Atomic Energy Agency
Investigators
| Principal Investigator: | Branislav Jeremic, MD | International Atomic Energy Agency |
More Information
Additional Information:
No publications provided
| Responsible Party: | International Atomic Energy Agency |
| ClinicalTrials.gov Identifier: | NCT00864331 History of Changes |
| Other Study ID Numbers: | E33029 |
| Study First Received: | March 17, 2009 |
| Last Updated: | October 12, 2011 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by International Atomic Energy Agency:
|
lung cancer nonsmall cell lung cancer radiation therapy chemotherapy Locally advanced and metastatic nonsmall cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013