Carcinoma, Small CellNCT02675088
Comparable Study of Different Thoracic Radiotherapy Regimens for Extensive Stage Small Cell Lung Cancer
A study testing high-dose TRT and standard-dose TRT in people with Carcinoma, Small Cell and Lung Neoplasms, run by Chinese Academy of Medical Sciences at 2 sites in China.
Trial summary
Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. A Dutch study recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of 3 Gy, could improve 2-year overall survival(OS) of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carcinoma, Small Cell, Lung Neoplasms
- What is being tested?
- high-dose TRT and standard-dose TRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 70 years old, ECOG 0-2.
- Patients with histologically or cytologically proved small cell lung cancer.
- Extensive stage small-cell lung cancer (ES-SCLC), was characterized by tumors beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes. According to 2007 AJCC cancer staging 7th edition, stage I-IIIB with lung metastases and stage IV should be defined as LD.
- Has 1-4 extracranial metastatic lesions.
- No brain or central nervous system (CNS) metastases.
- No prior history of anti-tumor treatment.
Show all 9Show fewer
- Response after 4 to 6 cycles of EP-based chemotherapy within the past 4 weeks.
- No severe internal diseases and no organ dysfunction.
- Written informed consent provided.
Who cannot join
- Malignant tumors of other sites. Non melanoma skin cancer and Cervical carcinoma in situ were not included if curable.
- Active heart disease or acute myocardial infarction happen in six months.
- Psychiatric history.
- Pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG).
- Uncontrolled diabetes or hypertension.
- Interstitial pneumonia or Active pulmonary fibrosis.
- Acute bacterial or fungal infection.
- Oral or intravenous use of steroids.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
LUHUA WANG, MD
Luhua Wang, MD
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 0571
ming chen, MD
About this study
Official title: Randomized Phase III Study Comparing Different Thoracic Radiotherapy Regimens in Patients With Extensive Stage Small Cell Lung Cancer Who Respond to Chemotherapy
Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. A Dutch study recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of 3 Gy, could improve 2-year overall survival(OS) of this patient group compared with non-TRT group. But intrathoracic progression was still high, either with or without progression elsewhere, occurring in 43.7% in the TRT group. The ideal TRT regimen for ES-SCLC is undefined. Maybe higher dose can provide better local control(LC) and overall survival. In this study, the investigators propose to give an increased dose of TRT to determine whether higher dose will improve 2-year OS, LC and progression-free survival.
Read the detailed description
This is a multicenter, prospective, randomised phase III study. For patients with ES-SCLC who respond to chemotherapy after four to six cycles of standard chemotherapy (platinum etoposide), 45Gy/15F of thoracic radiotherapy will be used in experimental arm, while 30Gy/10F of thoracic radiotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.
- Conditions
- Carcinoma, Small Cell, Lung Neoplasms
- Being tested
- high-dose TRT, standard-dose TRT
- Keywords
- Extensive Stage Small Cell Lung Cancer, thoracic radiotherapy, radiotherapy regimen
- Medical subject headings
- Carcinoma, Small Cell, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-dose TRTRadiation
every day, Monday-Friday, for a total of 3 weeks, 45 Gy/ 3 Gy/ 15 f
standard-dose TRTRadiation
every day, Monday-Friday, for a total of 2 weeks, 30 Gy/ 3 Gy/ 10 f
| Study group | Role | What they receive |
|---|---|---|
| high-dose TRT | Experimental | high-dose thoracic radiotherapy X-ray RT Receives: Radiation: high-dose TRT |
| standard-dose TRT | Active comparator | standard-dose thoracic radiotherapy XRT Receives: Radiation: standard-dose TRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
The time interval between diagnosis and death
Measured: 2 years
Secondary outcomes (3)
progression-free survival
The time interval between diagnosis and disease progression
Measured: 2 years
Incidence of tumor recurrence in local or regional area
Number of patients experienceing recurrences in local or regional area divided by number of all enrolled patients
Measured: 2 years
Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0
Number of patients experienceing any toxicities induced by radiotherapy or chemotherapy divided by number of all enrolled patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start1 Dec 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Small CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Fudan University, West China Hospital, Zhejiang Cancer Hospital, Tianjin Medical University Cancer Institute and Hospital
- Responsible party
- Principal investigator, Luhua Wang, Chinese Academy of Medical Sciences
- Investigators
- LuHua Wang, MD, Principal investigator, Cancer Hospital of CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675088
- Sponsor's protocol ID
- CH-L-045/1
- Status last verified
- Apr 2019
- First submitted
- 3 Feb 2016
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slotman BJ, van Tinteren H, Praag JO, Knegjens JL, El Sharouni SY, Hatton M, Keijser A, Faivre-Finn C, Senan S. Use of thoracic radiotherapy for extensive stage small-cell lung cancer: a phase 3 randomised controlled trial. Lancet. 2015 Jan 3;385(9962):36-42. doi: 10.1016/S0140-6736(14)61085-0. Epub 2014 Sep 14.
PubMed 25230595
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Study Comparing Different Thoracic Radiotherapy Regimens in Patients With Extensive Stage Small Cell Lung Cancer Who Respond to Chemotherapy
- ClinicalTrials.gov ID
- NCT02675088
- Acronym / sponsor ID
- CH-L-045/1
- Conditions
- Carcinoma, Small Cell, Lung Neoplasms
- Keywords
- Extensive Stage Small Cell Lung Cancer, thoracic radiotherapy, radiotherapy regimen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Fudan University, West China Hospital, Zhejiang Cancer Hospital, Tianjin Medical University Cancer Institute and Hospital
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. A Dutch study recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of 3 Gy, could improve 2-year overall survival(OS) of this patient group compared with non-TRT group. But intrathoracic progression was still high, either with or without progression elsewhere, occurring in 43.7% in the TRT group. The ideal TRT regimen for ES-SCLC is undefined. Maybe higher dose can provide better local control(LC) and overall survival. In this study, the investigators propose to give an increased dose of TRT to determine whether higher dose will improve 2-year OS, LC and progression-free survival.
Detailed description
This is a multicenter, prospective, randomised phase III study. For patients with ES-SCLC who respond to chemotherapy after four to six cycles of standard chemotherapy (platinum etoposide), 45Gy/15F of thoracic radiotherapy will be used in experimental arm, while 30Gy/10F of thoracic radiotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-dose TRT | Experimental | Radiation: high-dose TRThigh-dose thoracic radiotherapy X-ray RT |
| standard-dose TRT | Active comparator | Radiation: standard-dose TRTstandard-dose thoracic radiotherapy XRT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 - 70 years old, ECOG 0-2.
- Patients with histologically or cytologically proved small cell lung cancer.
- Extensive stage small-cell lung cancer (ES-SCLC), was characterized by tumors beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes. According to 2007 AJCC cancer staging 7th edition, stage I-IIIB with lung metastases and stage IV should be defined as LD.
- Has 1-4 extracranial metastatic lesions.
- No brain or central nervous system (CNS) metastases.
Key exclusion criteria (8 listed)
- Malignant tumors of other sites. Non melanoma skin cancer and Cervical carcinoma in situ were not included if curable.
- Active heart disease or acute myocardial infarction happen in six months.
- Psychiatric history.
- Pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG).
- Uncontrolled diabetes or hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-dose TRTevery day, Monday-Friday, for a total of 3 weeks, 45 Gy/ 3 Gy/ 15 f | Radiation | high-dose TRT |
| standard-dose TRTevery day, Monday-Friday, for a total of 2 weeks, 30 Gy/ 3 Gy/ 10 f | Radiation | standard-dose TRT |
Primary outcome
overall survival
Time frame: 2 years
The time interval between diagnosis and death
3 secondary outcomes
progression-free survival
Time frame: 2 years
Incidence of tumor recurrence in local or regional area
Time frame: 2 years
Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Results publication: PubMed 25230595Slotman BJ, van Tinteren H, Praag JO, Knegjens JL, El Sharouni SY, Hatton M, Keijser A, Faivre-Finn C, Senan S. Use of thoracic radiotherapy for extensive stage small-cell lung cancer: a phase 3 randomised controlled trial. Lancet. 2015 Jan 3;385(9962):36-42. doi: 10.1016/S0140-6736(14)61085-0. Epub 2014 Sep 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LuHua Wang, MD principal investigator
Cancer Hospital of CAMS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-dose TRT and standard-dose TRT in people with Carcinoma, Small Cell and Lung Neoplasms, run by Chinese Academy of Medical Sciences at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LuHua Wang, MD (+861087788799, wlhwq@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02675088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.