Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy

NCT00864331 | Completed Phase 3 DMC

• 1 other identifier: E33029
• Study Type: interventional
• Target: 251
• Locations: 12 countries
• Sites: 12

Brief Summary

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

Conditions

Non Small Cell Lung Cancer

Keywords

lung cancer; nonsmall cell lung cancer; radiation therapy; chemotherapy; Locally advanced and metastatic nonsmall cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Survival

  1 year

Secondary Outcomes (2)

• 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)

  1 year

• To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B

  1 year

Study Arms (4)

Radiotherapy

ACTIVE COMPARATOR

For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy.

Radiation: radiation

Chemotherapy and radiotherapy

EXPERIMENTAL

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

ACTIVE COMPARATOR

For patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy.

Drug: Chemotherapy

Palliative radiotherapy and chemotherapy

EXPERIMENTAL

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

Interventions

radiation RADIATION

39 Gy in 13 daily fractions of 3 Gy

Radiotherapy

Chemotherapy and radiotherapy OTHER

Chemotherapy followed by low dose palliative radiotherapy

Chemotherapy and radiotherapy

Chemotherapy DRUG

Chemotherapy given alone

Chemotherapy

Palliative radiotherapy and chemotherapy OTHER

Low dose palliative radiotherapy followed by chemotherapy

Palliative radiotherapy and chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Stage III B "wet" (existing pleural effusion , but not necessarily cytologically verified)
• RT field \> 200 cm2
• Pregnancy
• 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
• Brain metastasis (brain CT and/or MRI not needed, unless symptoms exist - clinically indicated)

Sponsors & Collaborators

• International Atomic Energy Agency: lead

Study Sites (13)

Instituto de Radiomedicine

Santiago, Chile

Location

Affiliated Hospital of Ning Xia Medical College, Department of Radiation Oncology

Yinchuan, China

Location

University of Zagreb Faculty of Medicine

Zagreb, Croatia

Location

Misr Oncology Center (MOC)

Cairo, Egypt

Location

Tata Memorial Centre (TMC) Department of Atomic Energy (DAE)

Mumbai, India

Location

General Hospital Kuala Lumpur, Institute of Radiotherapy and Oncology

Kuala Lumpur, Malaysia

Location

Sir Paul Boffa Hospital

Floriana, Malta

Location

Ministère de la Santé, Institut National d'Oncologie Sidi Mohamed Ben Abdellah

Rabat, Morocco

Location

Nuclear Medicine Oncology and Radiotherapy Institute

Islamabad, Pakistan

Location

Instituto Oncológico National

Panama City, Panama

Location

Instituto Nacional de Enfermadades Neoplasicas Depto. De Radioterapia

Lima, Peru

Location

University of Witwatersrand Johannesburg Hospital Dept of Radiation Oncology

Johannesburg, South Africa

Location

Institut de la Sante Publique, Institut National de Cancer Salah Azaiz

Tunis, Tunisia

Location

Related Publications (1)

• Jeremic B, Fidarova E, Sharma V, Faheem M, Ameira AA, Nasr Ben Ammar C, Frobe A, Lau F, Brincat S, Jones G. The International Atomic Energy Agency (IAEA) randomized trial of palliative treatment of incurable locally advanced non small cell lung cancer (NSCLC) using radiotherapy (RT) and chemotherapy (CHT) in limited resource setting. Radiother Oncol. 2015 Jul;116(1):21-6. doi: 10.1016/j.radonc.2015.06.017. Epub 2015 Jul 7.

  PMID: 26163093 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Radiation; Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Therapeutics

Study Officials

• Elena Fidarova, MD

  International Atomic Energy Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: February 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

EG (1); CN (1); PA (1); ZA (1); IN (1); CL (1); MA (1); MO (1); CR (1); PE (1); TU (1); MY (1)