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Non-small Cell Lung CancerPhase 2NCT02720614

Hypofractionated Radiation Therapy Combined With Concurrent Chemotherapy for Patients With Non-small Cell Lung Cancer

A Phase 2 study testing Hypofractionated radiation/chemotherapy in people with Non-small Cell Lung Cancer, run by LIN QIANG.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety of accelerated hypofractionated three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy for patients with unresectable stage III non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Hypofractionated radiation/chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
May 2012to Nov 2014
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathological or cytological diagnose of unresectable stage III non-small cell lung cancer
  • The Karnofsky performance status (KPS) score ≥70.
  • The expected survival time ≥3 months.
  • Adequate blood, liver, lungs and kidney function
  • Accessible contact information
  • Informed consent required before enrollment.

Who cannot join

  • Pregnant or breastfeeding.
  • Another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years)
  • Cannot receive concurrent chemotherapy due to medical reasons.
  • Superior vena cava syndrome.
  • Severe lung diseases that affected lung function.

About this study

Official title: A Phase II Study of Accelerated Hypofractionated Three-dimensional Conformal Radiation Therapy Concurrent With Chemotherapy in Unresectable Stage III Non-small Cell Lung Cancer

The purpose of this study is to evaluate the safety of accelerated hypofractionated three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy for patients with unresectable stage III non-small cell lung cancer.

Read the detailed description

Increasing the biological effective dose (BED) of radiotherapy for non-small cell lung cancer (NSCLC) can increase local control rates and improve overall survival. Compared with conventional fractionated radiotherapy, accelerated hypofractionated radiotherapy can yield higher BED, shorten the total treatment time, and theoretically obtain better efficacy. However, currently, there is no optimal hypofractionated radiotherapy regimen. Based on phase I trial results, we performed this phase II trial to further evaluate the safety and preliminary efficacy of accelerated hypofractionated three-dimensional conformal radiation therapy(3-DCRT) combined with concurrent chemotherapy for patients with unresectable stage III NSCLC.

Patients with previously untreated unresectable stage III NSCLC received 3-DCRT with a total dose of 69 Gy, delivered at 3 Gy per fraction, once daily, five fractions per week, completed within 4.6 weeks. At the same time, platinum doublet chemotherapy was applied.

Being tested
Hypofractionated radiation/chemotherapy
Keywords
accelerated hypofractionated radiotherapy, three-dimensional conformal radiation therapy, concurrent radiochemotherapy
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.

  • Hypofractionated radiation/chemotherapyRadiation

    Procedure: Radiation Therapy Drug: Vinorelbine Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin

Study groups in NCT02720614
Study groupRoleWhat they receive
Hypofractionated radiation/chemotherapyExperimentalHypofractionated radiation：Patients receive accelerated hypofractionated radiation: three-dimensional conformal radiation therapy (3-DCRT) with a total dose of 69 Gy, delivered at 3 Gy per fraction, once daily, five fractions per week, completed within 4.6 weeks. Chemotherapy: Regimen 1 is as follows: vinorelbine (NVB) was administered by intravenous infusion at a dose of 25 mg/m2 on day 1 (d1) and day 8 (d8), and carboplatin (CBP) is administered at a concentration-time curve (AUC) of 5 mg/ml on d8. This treatment was repeated every 28 days. One cycle of chemotherapy is performed concurrently with the radiotherapy. Chemotherapy: Regimen 2 is as follows: paclitaxel at 30 mg/m2 and cisplatin at 20 mg/m2 (TP) are administrated every week for 5 weeks continuously.
Receives: Radiation: Hypofractionated radiation/chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Severe and Life-threatening Adverse Events (AE)

    intolerable toxicities: severe and life-threatening adverse events (Grade III/IV in Common Terminology Criteria for Adverse Events v3.0 (CTCAE 3.0))

    Measured: Baseline to the time of intolerable toxicity(up to 1 year) or measured Progressive Disease (PD)

Secondary outcomes (1)

  1. Percentage of Participants with Progression Free Survival (PFS) at 1 Year

    Measured: Baseline and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2016 (estimated)
  2. Study startMay 2012
  3. Primary completionJul 2014
  4. Study completionNov 2014

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02720614
Sponsor's protocol ID
NorthChinaPBGH
Status last verified
Mar 2016
First submitted
23 Mar 2016
Last updated
28 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.

    PubMed 21351269

  • Chen W, Zheng R, Zhang S, Zhao P, Zeng H, Zou X. Report of cancer incidence and mortality in China, 2010. Ann Transl Med. 2014 Jul;2(7):61. doi: 10.3978/j.issn.2305-5839.2014.04.05.

    PubMed 25333036

  • Bayman N, Blackhall F, McCloskey P, Taylor P, Faivre-Finn C. How can we optimise concurrent chemoradiotherapy for inoperable stage III non-small cell lung cancer? Lung Cancer. 2014 Feb;83(2):117-25. doi: 10.1016/j.lungcan.2013.11.017. Epub 2013 Dec 1.

    PubMed 24373738

  • Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.

    PubMed 20351327

  • Kong FM, Ten Haken RK, Schipper MJ, Sullivan MA, Chen M, Lopez C, Kalemkerian GP, Hayman JA. High-dose radiation improved local tumor control and overall survival in patients with inoperable/unresectable non-small-cell lung cancer: long-term results of a radiation dose escalation study. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):324-33. doi: 10.1016/j.ijrobp.2005.02.010.

    PubMed 16168827

  • Lin Q, Liu YE, Ren XC, Wang N, Chen XJ, Wang DY, Zong J, Peng Y, Guo ZJ, Hu J. Dose escalation of accelerated hypofractionated three-dimensional conformal radiotherapy (at 3 Gy/fraction) with concurrent vinorelbine and carboplatin chemotherapy in unresectable stage III non-small-cell lung cancer: a phase I trial. Radiat Oncol. 2013 Aug 17;8(1):201. doi: 10.1186/1748-717X-8-201.

    PubMed 23957889

  • Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16.

    PubMed 25601342

  • Koukourakis M, Hlouverakis G, Kosma L, Skarlatos J, Damilakis J, Giatromanolaki A, Yannakakis D. The impact of overall treatment time on the results of radiotherapy for nonsmall cell lung carcinoma. Int J Radiat Oncol Biol Phys. 1996 Jan 15;34(2):315-22. doi: 10.1016/0360-3016(95)02102-7.

    PubMed 8567332

  • Beli I, Koukourakis G, Platoni K, Tolia M, Kelekis N, Kouvaris J, Syrigos C, Mystakidou K, Varveris C, Kouloulias V. Hypofractionated radiotherapy in non small cell lung cancer: a review of the current literature. Rev Recent Clin Trials. 2010 May;5(2):103-11. doi: 10.2174/157488710791233608.

    PubMed 20423316

  • Oh D, Ahn YC, Kim B, Pyo H. Hypofractionated three-dimensional conformal radiation therapy alone for centrally located cT1-3N0 non-small-cell lung cancer. J Thorac Oncol. 2013 May;8(5):624-9. doi: 10.1097/JTO.0b013e31828cb6db.

    PubMed 23584294

  • Faria SL, Souhami L, Portelance L, Duclos M, Vuong T, Small D, Freeman CR. Absence of toxicity with hypofractionated 3-dimensional radiation therapy for inoperable, early stage non-small cell lung cancer. Radiat Oncol. 2006 Nov 1;1:42. doi: 10.1186/1748-717X-1-42.

    PubMed 17078878

  • Amini A, Lin SH, Wei C, Allen P, Cox JD, Komaki R. Accelerated hypofractionated radiation therapy compared to conventionally fractionated radiation therapy for the treatment of inoperable non-small cell lung cancer. Radiat Oncol. 2012 Mar 15;7:33. doi: 10.1186/1748-717X-7-33.

    PubMed 22420631

  • McPartlin AJ, Chaudhry S, Swindell R, Bayman N, Burt P, Chittalia A, Cootes J, Faivre Finn C, Harris M, Lander H, Lee L, Sheikh H, Pemberton L. The largest UK single centre series using hypofractionated radical radiotherapy for NSCLC in the very elderly. Lung Cancer. 2013 Jul;81(1):144. doi: 10.1016/j.lungcan.2013.03.010. Epub 2013 May 2. No abstract available.

    PubMed 23643277

  • Bral S, Duchateau M, Versmessen H, Engels B, Tournel K, Vinh-Hung V, De Ridder M, Schallier D, Storme G. Toxicity and outcome results of a class solution with moderately hypofractionated radiotherapy in inoperable Stage III non-small cell lung cancer using helical tomotherapy. Int J Radiat Oncol Biol Phys. 2010 Aug 1;77(5):1352-9. doi: 10.1016/j.ijrobp.2009.06.075. Epub 2010 Jan 7.

    PubMed 20056350

  • Tho LM, Mahmood R, Leitch M, Brisbane I, Kakumanu S, Mohammed N. Oesophageal toxicity and hypofractionated concurrent chemoradiotherapy for non-small cell lung cancer. Clin Oncol (R Coll Radiol). 2009 Feb;21(1):74. doi: 10.1016/j.clon.2008.10.003. Epub 2008 Nov 5. No abstract available.

    PubMed 18986800

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hypofractionated radiation/chemotherapy in people with Non-small Cell Lung Cancer, run by LIN QIANG.

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 6 inclusion and 5 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: finished, as of the sponsor's last update on 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants with Severe and Life-threatening Adverse Events (AE) (time frame: Baseline to the time of intolerable toxicity(up to 1 year) or measured Progressive Disease (PD)). 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 NCT02720614, which also lists 24 linked publications.

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 28 Mar 2016.

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