Non Small Cell Lung CancerPhase 2PLANETNCT01664663
Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy
A Phase 2 study testing Standard radiochemotherapy to 68 Gy and Dose escalated radiochemotherapy up to 84 Gy in people with Non Small Cell Lung Cancer and Locally Advanced Disease, run by Ass. Prof. Jan Nyman at 3 sites in Sweden.
Trial summary
The purpose of this study is to examine the valu of individually dose escalated radiotherapy compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with good performance status. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Locally Advanced Disease
- What is being tested?
- Standard radiochemotherapy to 68 Gy and Dose escalated radiochemotherapy up to 84 Gy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesSweden
- Study dates
- Sep 2011to Oct 2015
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological diagnosis of NSCLC stage IIIA-B.
- Nonresectable or medically inoperable patients.
- No prior chemo- or radiotherapy for NSCLC.
- PS 0-1.
- FEV1 > 1 l or > 40% and CO diffusion capacity > 40%.
- Patient compliance and geographic proximity that allow adequate follow-up.
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- Adequate bone marrow reserve: WBCC >3.0, platelets >100, haemoglobin > 100.
- Written informed concent.
- Effective use of contraception.
Who cannot join
- Excessive weight loss within 6 months (> 10%).
- Supraclavicular nodes.
- Apical tumors-pancoast.
- T4 tumors with separate manifestations in different lobes.
- Evidence of active serious infections.
- Inadequate liver function.
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- Inadequate kidney function.
- Pregnancy.
- Breast feeding.
- Serious concomitant systemic disorder.
- Second primary malignancy the last 5 years.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 413 45
Department of Oncology, Karolinska University Hospital
Stockholm, Stockholm County, 171 76
Department of Oncology, Norrlands Universitetssjukhus
Umeå, Norrland, 901 85
About this study
Official title: Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy
The purpose of this study is to examine the valu of individually dose escalated radiotherapy compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with good performance status.
Read the detailed description
This is an open label, multicentre phase II trial of individually escalated radiotherapy up to 84 Gy due to normal tissue dose constraints combined with standard concurrent chemotherapy (cisplatin-vinorelbine) compared to standard dose radiotherapy (68 Gy) combined with the same chemotherapy. There are restrictions due to lung function, performance status and pre-treatment weight loss. The main endpoint is progression free survival and additional endpoints are local control, overall survival, toxicity quality of life and relapse pattern.
- Being tested
- Standard radiochemotherapy to 68 Gy, Dose escalated radiochemotherapy up to 84 Gy
- Keywords
- Radiotherapy, Dose escalation, Normal tissue constraints, Locally advanced disease, Good performance status
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard radiochemotherapy to 68 GyRadiation
Dose escalated radiochemotherapy up to 84 GyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Arm A:Standard radiochemotherapy | Active comparator | Radiotherapy with 2 Gy per fractions 5 fractions a week to 68 Gy to the planning target volume. Three courses of cisplatin 75 mg/m2 day 1and vinorelbine 25 mg/m2 day 1+8. Two courses concomitant with radiation. Receives: Radiation: Standard radiochemotherapy to 68 Gy |
| Arm B Escalated radiochemotherapy | Experimental | Radiotherapy with 2 Gy per fraction 5 or 6 times a week to 68-84 Gy to the planning target volume due to normal tissue tolerance constraints. Dose to lung tissue, esophagus and spinal cord will be considered. Three courses of cisplatin 75 mg/m2 day 1 and vinorelbine 25 mg/m2 day 1+8 will be given, two courses concomitant with radiation. Receives: Radiation: Dose escalated radiochemotherapy up to 84 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 36 monts after randomization
Secondary outcomes (1)
Numbers of patients without progression of locoregional disease
Measured with CT-scan according to the RECIST criteria for response
Measured: 36 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startSep 2011
- Primary completionNov 2013
- Study completionOct 2015 (estimated)
Why it stopped: Safety analysis showed increased grade 5 toxicity in experimental arm.
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 Non Small Cell Lung CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ass. Prof. Jan Nyman
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group
- Investigators
- Jan Nyman, Ass. prof, Principal investigator, Swedish Lung Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664663
- Sponsor's protocol ID
- PLANET
- Acronym
- PLANET
- Status last verified
- Dec 2014
- First submitted
- 10 Aug 2012
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hallqvist A, Bergstrom S, Bjorkestrand H, Svard AM, Ekman S, Lundin E, Holmberg E, Johansson M, Friesland S, Nyman J. Dose escalation to 84 Gy with concurrent chemotherapy in stage III NSCLC appears excessively toxic: Results from a prematurely terminated randomized phase II trial. Lung Cancer. 2018 Aug;122:180-186. doi: 10.1016/j.lungcan.2018.06.020. Epub 2018 Jun 18.
PubMed 30032828
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy
- ClinicalTrials.gov ID
- NCT01664663
- Acronym / sponsor ID
- PLANET / PLANET
- Keywords
- Radiotherapy, Dose escalation, Normal tissue constraints, Locally advanced disease, Good performance status
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety analysis showed increased grade 5 toxicity in experimental arm.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Ass. Prof. Jan NymanResearch network
- Study start
- Sep 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Oct 2015 (estimated)
- First posted
- 14 Aug 2012 (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.
The purpose of this study is to examine the valu of individually dose escalated radiotherapy compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with good performance status.
Detailed description
This is an open label, multicentre phase II trial of individually escalated radiotherapy up to 84 Gy due to normal tissue dose constraints combined with standard concurrent chemotherapy (cisplatin-vinorelbine) compared to standard dose radiotherapy (68 Gy) combined with the same chemotherapy. There are restrictions due to lung function, performance status and pre-treatment weight loss. The main endpoint is progression free survival and additional endpoints are local control, overall survival, toxicity quality of life and relapse pattern.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A:Standard radiochemotherapy | Active comparator | Radiation: Standard radiochemotherapy to 68 GyRadiotherapy with 2 Gy per fractions 5 fractions a week to 68 Gy to the planning target volume. Three courses of cisplatin 75 mg/m2 day 1and vinorelbine 25 mg/m2 day 1+8. Two courses concomitant with radiation. |
| Arm B Escalated radiochemotherapy | Experimental | Radiation: Dose escalated radiochemotherapy up to 84 GyRadiotherapy with 2 Gy per fraction 5 or 6 times a week to 68-84 Gy to the planning target volume due to normal tissue tolerance constraints. Dose to lung tissue, esophagus and spinal cord will be considered. Three courses of cisplatin 75 mg/m2 day 1 and vinorelbine 25 mg/m2 day 1+8 will be given, two courses concomitant with radiation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological or cytological diagnosis of NSCLC stage IIIA-B.
- Nonresectable or medically inoperable patients.
- No prior chemo- or radiotherapy for NSCLC.
- PS 0-1.
- FEV1 > 1 l or > 40% and CO diffusion capacity > 40%.
Key exclusion criteria (11 listed)
- Excessive weight loss within 6 months (> 10%).
- Supraclavicular nodes.
- Apical tumors-pancoast.
- T4 tumors with separate manifestations in different lobes.
- Evidence of active serious infections.
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 |
|---|---|---|
| Standard radiochemotherapy to 68 Gy | Radiation | Arm A:Standard radiochemotherapy |
| Dose escalated radiochemotherapy up to 84 Gy | Radiation | Arm B Escalated radiochemotherapy |
Primary outcome
Progression free survival
Time frame: 36 monts after randomization
1 secondary outcome
Numbers of patients without progression of locoregional disease
Time frame: 36 months after randomization
Results and safety
The study was stopped early (reason given: Safety analysis showed increased grade 5 toxicity in experimental arm.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- Derived from this study: PubMed 30032828Hallqvist A, Bergstrom S, Bjorkestrand H, Svard AM, Ekman S, Lundin E, Holmberg E, Johansson M, Friesland S, Nyman J. Dose escalation to 84 Gy with concurrent chemotherapy in stage III NSCLC appears excessively toxic: Results from a prematurely terminated randomized phase II trial. Lung Cancer. 2018 Aug;122:180-186. doi: 10.1016/j.lungcan.2018.06.020. Epub 2018 Jun 18.
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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.
Jan Nyman, Ass. prof principal investigator
Swedish Lung Cancer Study Group
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard radiochemotherapy to 68 Gy and Dose escalated radiochemotherapy up to 84 Gy in people with Non Small Cell Lung Cancer and Locally Advanced Disease, run by Ass. Prof. Jan Nyman at 3 sites in Sweden.
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 11 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: stopped early, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Safety analysis showed increased grade 5 toxicity in experimental arm.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 36 monts after randomization). 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 NCT01664663, 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 9 Dec 2014.