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Loco-regionally Recurrent NSCLC After Thoracic RadiotherapyPhase 2NCT04275687

Thoracic Re-irradiation For Locoregionally Recurrent Non-small Cell Lung Cancer

A Phase 2 study testing thoracic irradiation and Concurrent chemotherapy in people with Loco-regionally Recurrent NSCLC After Thoracic Radiotherapy, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This prospective phase II study is to assess the efficacy and safety of thoracic re-irradiation for locoregionally recurrent non-small cell lung cancer using hypofractionated technique. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
thoracic irradiation and Concurrent chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
1 Mar 2020to 1 Feb 2025
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

  • loco-regionally recurrent NSCLC after thoracic radiotherapy (confirmed by pathology or continuous enhanced CT imaging);
  • chemotherapy, targeted or immunotherapy are allowed before enrollment;
  • >=6 months from previous chest radiotherapy;
  • presence of measurable disease according to RECIST criteria;
  • ECOG performance score is 0-1;
  • organ and bone marrow functions meet the following criteria:
Show all 14Show fewer
  • forced expiratory volume in 1 second (FEV1) ≥ 0.8L;
  • percentage-predicted single-breath carbon monoxide diffusing capacity (DLCO %) > 60%;
  • absolute neutrophil count ≥1.5×10^9/L;
  • platelet ≥80×10^9/L;
  • hemoglobin ≥9.0g/dL;
  • serum creatinine clearance was ≥50 mL/min calculated based on the Cockcroft-Gault formula
  • serum bilirubin ≤1.5 times normal upper limit (ULN)
  • AST and ALT≤2.5 times ULN

Who cannot join

  • previous or concurrent with other malignant tumors, except for non-melanoma of the skin or carcinoma in situ of the cervix;
  • loco-regional recurrence with distant metastasis;
  • any other disease or condition contradicted to radiotherapy (e.g., active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
  • women who are pregnant or breastfeeding, women who have not undergone a pregnancy test (within 14 days before first administration), and women who are pregnant;
  • pregnancy, lactation, or fertility but no contraceptive measures;
  • those with bleeding tendency;
Show all 11Show fewer
  • participate in other clinical trials within 30 days before enrollment;
  • drug and other drug addiction, chronic alcoholism and AIDS patients;
  • having uncontrollable seizures or loss of self-control due to psychosis;
  • a history of severe allergies;
  • participants considered unfit to participate in this study.

Trial locations and contacts

1 site in 1 country.

Bo Qiu, Ph.D contact

+86-020-87343031

qiubo@sysucc.org.cn

Hui Liu, Prof. contact

+86-020-87343031

liuhui@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University

    Guangzhou, 510000

    Hui Liu, Professor, +86-020-87343031, liuhui@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: Thoracic Re-irradiation For Locoregionally Recurrent Non-small Cell Lung Cancer Using Hypofractionated Technique.

This prospective phase II study is to assess the efficacy and safety of thoracic re-irradiation for locoregionally recurrent non-small cell lung cancer using hypofractionated technique.

Read the detailed description

This prospective phase II study is to assess the efficacy and safety of thoracic re-irradiation for locoregionally recurrent non-small cell lung cancer using hypofractionated technique.

  1. For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.
  2. For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4~7 daily fractions as a boost. Concurrent chemotherapy consists of weekly docetaxel and nedaplatin.
Being tested
thoracic irradiation, Concurrent chemotherapy
Keywords
loco-regionally recurrent non-small cell lung cancer, thoracic irradiation, hypofraction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • thoracic irradiationRadiation

    For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.

    For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4~7 daily fractions as a boost.

  • Concurrent chemotherapyDrug

    For centrally located recurrent tumors, concurrent chemotherapy consists of weekly docetaxel and nedaplatin.

Study groups in NCT04275687
Study groupRoleWhat they receive
thoracic irradiationExperimentalFor peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions. For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4~7 daily fractions as a boost. Concurrent chemotherapy consists of weekly docetaxel and nedaplatin.
Receives: Radiation: thoracic irradiation; Drug: Concurrent chemotherapy

What is being measured

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

  1. Overall Survival

    Measured: 2 years

Secondary outcomes (2)

  1. Local Control

    Measured: 2 Years

  2. Incidence of Grade ≥3 pulmonary toxicity/esophageal toxicity

    Measured: 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 posted19 Feb 2020
  2. Study start1 Mar 2020 (estimated)
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion1 Feb 2025 (estimated)

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
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04275687
Sponsor's protocol ID
GASTO1057
Status last verified
Feb 2020
First submitted
17 Feb 2020
Last updated
21 Feb 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

    PubMed 21296855

  • Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR; American Society of Clinical Oncology. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol. 2004 Jan 15;22(2):330-53. doi: 10.1200/JCO.2004.09.053. Epub 2003 Dec 22. No abstract available.

    PubMed 14691125

  • Goldstraw P, Chansky K, Crowley J, Rami-Porta R, Asamura H, Eberhardt WE, Nicholson AG, Groome P, Mitchell A, Bolejack V; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee Advisory Boards and Participating Institutions. The IASLC Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groupings in the Forthcoming (Eighth) Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2016 Jan;11(1):39-51. doi: 10.1016/j.jtho.2015.09.009.

    PubMed 26762738

  • Curran WJ Jr, Paulus R, Langer CJ, Komaki R, Lee JS, Hauser S, Movsas B, Wasserman T, Rosenthal SA, Gore E, Machtay M, Sause W, Cox JD. Sequential vs. concurrent chemoradiation for stage III non-small cell lung cancer: randomized phase III trial RTOG 9410. J Natl Cancer Inst. 2011 Oct 5;103(19):1452-60. doi: 10.1093/jnci/djr325. Epub 2011 Sep 8.

    PubMed 21903745

  • Milton DT, Miller VA. Advances in cytotoxic chemotherapy for the treatment of metastatic or recurrent non-small cell lung cancer. Semin Oncol. 2005 Jun;32(3):299-314. doi: 10.1053/j.seminoncol.2005.02.011.

    PubMed 15988685

  • Noble J, Ellis PM, Mackay JA, Evans WK; Lung Cancer Disease Site Group of Cancer Care Ontario's Program in Evidence-based Care. Second-line or subsequent systemic therapy for recurrent or progressive non-small cell lung cancer: a systematic review and practice guideline. J Thorac Oncol. 2006 Nov;1(9):1042-58.

    PubMed 17409993

  • Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8.

    PubMed 27718847

  • Kruser TJ, McCabe BP, Mehta MP, Khuntia D, Campbell TC, Geye HM, Cannon GM. Reirradiation for locoregionally recurrent lung cancer: outcomes in small cell and non-small cell lung carcinoma. Am J Clin Oncol. 2014 Feb;37(1):70-6. doi: 10.1097/COC.0b013e31826b9950.

    PubMed 23357968

  • Vyfhuis MAL, Rice S, Remick J, Mossahebi S, Badiyan S, Mohindra P, Simone CB 2nd. Reirradiation for locoregionally recurrent non-small cell lung cancer. J Thorac Dis. 2018 Aug;10(Suppl 21):S2522-S2536. doi: 10.21037/jtd.2017.12.50.

    PubMed 30206496

  • 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

  • Schild SE, McGinnis WL, Graham D, Hillman S, Fitch TR, Northfelt D, Garces YI, Shahidi H, Tschetter LK, Schaefer PL, Adjei A, Jett J. Results of a Phase I trial of concurrent chemotherapy and escalating doses of radiation for unresectable non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1106-11. doi: 10.1016/j.ijrobp.2006.02.046. Epub 2006 May 26.

    PubMed 16730134

  • Reyngold M, Wu AJ, McLane A, Zhang Z, Hsu M, Stein NF, Zhou Y, Ho AY, Rosenzweig KE, Yorke ED, Rimner A. Toxicity and outcomes of thoracic re-irradiation using stereotactic body radiation therapy (SBRT). Radiat Oncol. 2013 Apr 25;8:99. doi: 10.1186/1748-717X-8-99.

    PubMed 23617949

  • Spoelstra FO, Pantarotto JR, van Sornsen de Koste JR, Slotman BJ, Senan S. Role of adaptive radiotherapy during concomitant chemoradiotherapy for lung cancer: analysis of data from a prospective clinical trial. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1092-7. doi: 10.1016/j.ijrobp.2008.12.027. Epub 2009 Mar 26.

    PubMed 19327915

  • Gielda BT, Marsh JC, Zusag TW, Faber LP, Liptay M, Basu S, Warren WH, Fidler MJ, Batus M, Abrams RA, Bonomi P. Split-course chemoradiotherapy for locally advanced non-small cell lung cancer: a single-institution experience of 144 patients. J Thorac Oncol. 2011 Jun;6(6):1079-86. doi: 10.1097/JTO.0b013e3182199a7c.

    PubMed 21532501

  • Furuse K, Fukuoka M, Kawahara M, Nishikawa H, Takada Y, Kudoh S, Katagami N, Ariyoshi Y. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 1999 Sep;17(9):2692-9. doi: 10.1200/JCO.1999.17.9.2692.

    PubMed 10561343

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing thoracic irradiation and Concurrent chemotherapy in people with Loco-regionally Recurrent NSCLC After Thoracic Radiotherapy, run by Sun Yat-sen University at 1 site 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 14 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: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bo Qiu, Ph.D (+86-020-87343031, qiubo@sysucc.org.cn), 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 NCT04275687, which also lists 19 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 21 Feb 2020.

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