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Lung AdenocarcinomaPhase 2NCT03905317

Bevacizumab and Radiotherapy for Oligometastasis of Lung Adenocarcinoma With Negative Driver Gene

A Phase 2 study testing Bevacizumab Injection, chest radiation and concurrent chemotherapy in people with Lung Adenocarcinoma, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 determined to explore the efficacy and safety of radiotherapy and bevacizumab maintenance therapy for oligometastatic lung adenocarcinoma with negative driver genes Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Adenocarcinoma
What is being tested?
Bevacizumab Injection, chest radiation and concurrent chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
1 Mar 2019to Feb 2022
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 confirmation of lung adenocarcinoma with negative driver gene including EGFR and ALK.
  • Simultaneous oligometastasis, or oligometastasis which occurs after treatment of stage i-iii lung adenocarcinoma (1-5 metastases)
  • Oligometasis confirmed by CT, brain MR, bone ECT or PETCT within 30 days before enrollment.

Who cannot join

  • ≥18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Organ and bone marrow functions are normal within the first 30 days of enrollment, including: • AST, ALT≤ 2.5*ULN or ≤5*ULN (with liver metastasis); • TBil ≤ 1.5 ULN • neutrophils absolute value ≥500 cells/mm3 • creatinine clearance ≥45 mL/min ;• platelets≥50,000 cells/mm3.
  • Negative pregnancy test 1 week before enrollment for women of childbearing age.
  • Patients with concurrent oligostasis should have received at least 4 courses of first-line chemotherapy, and SD or PR should be evaluated after chemotherapy;
  • Patients with stage i-iii lung adenocarcinoma with oligo-metastasis after treatment who have previously received systemic chemotherapy (such as concurrent radiotherapy chemotherapy or postoperative adjuvant chemotherapy) are admitted to the group;
Show all 33Show fewer
  • Patients who have received brain radiation therapy due to brain metastasis are admitted to the group.
  • The baseline is the exsiting of measurable lesions, and the metastatic lesions are treated with local radiotherapy;The number of metastases defines as:
  • - A) two metastatic lesions are identified when bilateral adrenal glands have lesions;
  • - B) two consecutive vertebral lesions and paravertebral lesions within 6cm can be considered as one metastatic lesion, and the lesions of non-continuous vertebral body should be counted separately;
  • - C) the adjacent lesions in the liver, lung and mediastinum can be considered as a metastatic lesion if one isocentric irradiation can be used;
  • For simultaneous oligostasis, the feasibility of primary focus radiotherapy should be evaluated, and the primary focus must be capable of receiving radiotherapy before being enrolled;For the primary lesion, SBRT or fractionated radiotherapy can be applied according to the site and surrounding invasion.
  • For the heterogeneous oligometastasis of the primary lesion that has received surgery or local radiotherapy, the feasibility of local radiotherapy should be evaluated when the local recurrence lesion occurs, and the local recurrence lesion can be treated with subdivided radiotherapy or SBRT before inclusion;
  • Patients with intracranial metastasis are allowed to be enrolled, but the intracranial lesions should be treated in advance and be in a stable state, and the number of intracranial lesions should be counted within the number of metastases.
  • Patients should be enrolled within 35 days after the last systemic treatment;
  • Patients and their family signed the informed consents.
  • Lung squamous carcinoma.
  • The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava).
  • The tumor is associated with a cavity over 2cm in diameter.
  • Bleeding tendency or coagulation disorder.
  • Patients with hemoptysis (1/2 teaspoon blood/day) within 1 month.
  • Full-dose anticoagulation therapy was used within the past 1 month.
  • Severe vascular disease occurred within 6 months.
  • Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months.
  • Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months.
  • Uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100mmHg).
  • Major surgery within 28 days or minor surgery or needle biopsy within 48 hours.
  • Urine protein 3-4+, or 24h urine protein quantitative >1g.
  • ≥Degree 3 esophagitis after chemoradiotherapy has not recovered.
  • The investigator does not consider the participant to be eligible for this study.
  • Metastatic lesions involving esophagus, stomach, small intestine or mesenteric lymph nodes;
  • The metastatic lesion is adjacent to the primary radiation range, and the radiotherapy physician cannot tolerate the secondary radiotherapy;
  • Malignant pleural effusion without obvious remission after first-line chemotherapy.

Trial locations and contacts

1 site in 1 country.

Bo Qiu, Attending contact

+86-020-87343031

qiubo@sysucc.org.cn

Hui liu, Professor contact

+86-020-87343031

liuhui@sysucc.org.cn

China1 site, 1 recruiting

  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Bo Qiu, Attending, +86-020-87343031, qiubo@sysucc.org.cn

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

    Recruiting

Other trials in China

About this study

Official title: A Single-Armed Phase II Study of Radiation and Bevacizumab Maintenance Therapy for Oligometastasis of Lung Adenocarcinoma With Negative Driver Gene

This prospective phase II study is determined to explore the efficacy and safety of radiotherapy and bevacizumab maintenance therapy for oligometastatic lung adenocarcinoma with negative driver genes

Read the detailed description

This prospective phase II study is determined to explore the efficacy and safety of radiotherapy and bevacizumab maintenance therapy for oligometastatic lung adenocarcinoma with negative driver genes.

The patients receive SBRT radiotherapy for the primary (if any) and metastatic lesions or divided radiotherapy with or without concurrent chemotherapy.Bevacizumab maintenance therapy starts 1-2 months later after the chemotherapy.The recommended dose for intravenous infusion is 15mg/kg body weight, and the drug is given every 3 weeks until disease progression or intolerable toxicity occurs. Toxicities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0.

Being tested
Bevacizumab Injection, chest radiation, concurrent chemotherapy
Keywords
bevacizumab, chemoradiotherapy, Oligometastasis of lung adenocarcinoma
Medical subject headings
Adenocarcinoma of Lung

What participants receive

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

  • Bevacizumab InjectionDrug

    Bevacizumab maintenance therapy starts 1-2 months later after the chemotherapy.The recommended dose for intravenous infusion is 15mg/kg body weight, and the drug is given every 3 weeks until disease progression or intolerable toxicity occurs.

  • chest radiationRadiation

    The patients receive SBRT radiotherapy for the primary (if any) and metastatic lesions or divided radiotherapy with or without concurrent chemotherapy.

  • concurrent chemotherapyDrug

    weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation

Study groups in NCT03905317
Study groupRoleWhat they receive
BevacizumabExperimentalThe patients receive SBRT radiotherapy for the primary (if any) and metastatic lesions or divided radiotherapy with or without concurrent chemotherapy.Bevacizumab maintenance therapy starts 1-2 months later after the chemotherapy.The recommended dose for intravenous infusion is 15mg/kg body weight, and the drug is given every 3 weeks until disease progression or intolerable toxicity occurs.
Receives: Drug: Bevacizumab Injection; Radiation: chest radiation; Drug: concurrent chemotherapy

What is being measured

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

  1. PFS

    Progression-free survival in patients

    Measured: 3-year

Secondary outcomes (4)

  1. OS

    overall survival in patients

    Measured: 3-year

  2. response rate

    Measured: 3-year

  3. rate of grade 3-4 radiation esophagitis

    Measured: 3-year

  4. rate of grade 3-4 radiation pneumonitis

    Measured: 3-year

Timeline

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

  1. First posted5 Apr 2019
  2. Study start1 Mar 2019
  3. Primary completionFeb 2022 (estimated)
  4. Study completionFeb 2022 (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
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03905317
Sponsor's protocol ID
GASTO-1047
Status last verified
Feb 2019
First submitted
15 Mar 2019
Last updated
5 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10. doi: 10.1200/JCO.1995.13.1.8. No abstract available.

    PubMed 7799047

  • Albain KS, Crowley JJ, LeBlanc M, Livingston RB. Survival determinants in extensive-stage non-small-cell lung cancer: the Southwest Oncology Group experience. J Clin Oncol. 1991 Sep;9(9):1618-26. doi: 10.1200/JCO.1991.9.9.1618.

    PubMed 1651993

  • Parikh RB, Cronin AM, Kozono DE, Oxnard GR, Mak RH, Jackman DM, Lo PC, Baldini EH, Johnson BE, Chen AB. Definitive primary therapy in patients presenting with oligometastatic non-small cell lung cancer. Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):880-7. doi: 10.1016/j.ijrobp.2014.04.007. Epub 2014 May 24.

    PubMed 24867533

  • Lewis SL, Porceddu S, Nakamura N, Palma DA, Lo SS, Hoskin P, Moghanaki D, Chmura SJ, Salama JK. Definitive Stereotactic Body Radiotherapy (SBRT) for Extracranial Oligometastases: An International Survey of >1000 Radiation Oncologists. Am J Clin Oncol. 2017 Aug;40(4):418-422. doi: 10.1097/COC.0000000000000169.

    PubMed 25647831

  • Xanthopoulos EP, Handorf E, Simone CB 2nd, Grover S, Fernandes AT, Sharma S, Corradetti MN, Evans TL, Langer CJ, Mitra N, Shah A, Apisarnthanarax S, Lin LL, Rengan R. Definitive dose thoracic radiation therapy in oligometastatic non-small cell lung cancer: A hypothesis-generating study. Pract Radiat Oncol. 2015 Jul-Aug;5(4):e355-63. doi: 10.1016/j.prro.2014.11.006. Epub 2015 Jan 31.

    PubMed 25649540

  • Iyengar P, Kavanagh BD, Wardak Z, Smith I, Ahn C, Gerber DE, Dowell J, Hughes R, Abdulrahman R, Camidge DR, Gaspar LE, Doebele RC, Bunn PA, Choy H, Timmerman R. Phase II trial of stereotactic body radiation therapy combined with erlotinib for patients with limited but progressive metastatic non-small-cell lung cancer. J Clin Oncol. 2014 Dec 1;32(34):3824-30. doi: 10.1200/JCO.2014.56.7412. Epub 2014 Oct 27.

    PubMed 25349291

  • Collen C, Christian N, Schallier D, Meysman M, Duchateau M, Storme G, De Ridder M. Phase II study of stereotactic body radiotherapy to primary tumor and metastatic locations in oligometastatic nonsmall-cell lung cancer patients. Ann Oncol. 2014 Oct;25(10):1954-1959. doi: 10.1093/annonc/mdu370. Epub 2014 Aug 11.

    PubMed 25114022

  • Gomez DR, Blumenschein GR Jr, Lee JJ, Hernandez M, Ye R, Camidge DR, Doebele RC, Skoulidis F, Gaspar LE, Gibbons DL, Karam JA, Kavanagh BD, Tang C, Komaki R, Louie AV, Palma DA, Tsao AS, Sepesi B, William WN, Zhang J, Shi Q, Wang XS, Swisher SG, Heymach JV. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1672-1682. doi: 10.1016/S1470-2045(16)30532-0. Epub 2016 Oct 24.

    PubMed 27789196

  • Brodowicz T, Krzakowski M, Zwitter M, Tzekova V, Ramlau R, Ghilezan N, Ciuleanu T, Cucevic B, Gyurkovits K, Ulsperger E, Jassem J, Grgic M, Saip P, Szilasi M, Wiltschke C, Wagnerova M, Oskina N, Soldatenkova V, Zielinski C, Wenczl M; Central European Cooperative Oncology Group CECOG. Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in advanced non-small cell lung cancer: a phase III trial. Lung Cancer. 2006 May;52(2):155-63. doi: 10.1016/j.lungcan.2006.01.006. Epub 2006 Mar 29.

    PubMed 16569462

  • Gerber DE. Maintenance therapy for advanced lung cancer: who, what, and when? J Clin Oncol. 2013 Aug 20;31(24):2983-90. doi: 10.1200/JCO.2012.48.5201. Epub 2013 Jul 8.

    PubMed 23835703

  • Ciuleanu T, Brodowicz T, Zielinski C, Kim JH, Krzakowski M, Laack E, Wu YL, Bover I, Begbie S, Tzekova V, Cucevic B, Pereira JR, Yang SH, Madhavan J, Sugarman KP, Peterson P, John WJ, Krejcy K, Belani CP. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009 Oct 24;374(9699):1432-40. doi: 10.1016/S0140-6736(09)61497-5. Epub 2009 Sep 18.

    PubMed 19767093

  • Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16.

    PubMed 22341744

  • Fidias PM, Dakhil SR, Lyss AP, Loesch DM, Waterhouse DM, Bromund JL, Chen R, Hristova-Kazmierski M, Treat J, Obasaju CK, Marciniak M, Gill J, Schiller JH. Phase III study of immediate compared with delayed docetaxel after front-line therapy with gemcitabine plus carboplatin in advanced non-small-cell lung cancer. J Clin Oncol. 2009 Feb 1;27(4):591-8. doi: 10.1200/JCO.2008.17.1405. Epub 2008 Dec 15.

    PubMed 19075278

  • Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.

    PubMed 17167137

  • Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J Clin Oncol. 2009 Mar 10;27(8):1227-34. doi: 10.1200/JCO.2007.14.5466. Epub 2009 Feb 2.

    PubMed 19188680

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab Injection, chest radiation and concurrent chemotherapy in people with Lung Adenocarcinoma, 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 3 inclusion and 33 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 5 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 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, Attending (+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?

PFS (time frame: 3-year). 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 NCT03905317, 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 5 Apr 2019.

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