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Gastric CancerRECOMMENDNCT03413514

Real World Evidence for the Cycle of Neoadjuvant Chemotherapy in Gastric Cancer With Shared Decision Making

A study testing NACT, SDM and Surgery in people with Gastric Cancer, run by Peking 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of the study is to evaluate the maximal cycle of effective neoadjuvant chemotherapy for resectable gastric cancer, to determine what is the best cycle of neoadjuvant chemotherapy for the patients who receive neoadjuvant chemotherapy. Read more about this study

Who is it for?
Any age
Conditions the study is for
Gastric Cancer
What is being tested?
NACT, SDM and Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
3 Jan 2018to 3 Jan 2023
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically proven adenocarcinoma of the stomach
  • Clinical cT2N+M0,or cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and MRI and laparoscopy.
  • Receive neoadjuvant chemotherapy in clinical

Who cannot join

  • Contraindication for chemotherapy
  • Contraindication for surgery
  • Clinically apparent distant metastasis

Trial locations and contacts

1 site in 1 country.

Ziyu Li, MD contact

86-010-8819-6605

ligregory@outlook.com

Yinkui Wang, MD contact

86-010-88196598

wykchangfeng@163.com

China1 site, 1 recruiting

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Ziyu Li, M.D., 86-010-8819-6605, ligregory@outlook.com

    Yinkui Wang, M.D., 86-010-8819-6598, wykchangfeng@163.com

    Recruiting

Other trials in China

About this study

Official title: A Non-Randomized,Single Center Study to Investigate the Real World Evidence for the Maximal Cycle of Effective Neoadjuvant Chemotherapy in Gastric Cancer With Shared Decision Making

The purpose of the study is to evaluate the maximal cycle of effective neoadjuvant chemotherapy for resectable gastric cancer, to determine what is the best cycle of neoadjuvant chemotherapy for the patients who receive neoadjuvant chemotherapy.

Read the detailed description

The study is a non-randomized clinical trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. MRI and enhanced CT are used to evaluate the clinical response of the tumor. The primary endpoint is the maximal cycle of effective neoadjuvant chemotherapy for resectable gastric cancer.

Conditions
Gastric Cancer
Being tested
NACT, SDM, Surgery, ACT, Questionnaire
Keywords
shared decision making, neoadjuvant chemotherapy, cycle, MRI, clinical response
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • NACTDrug

    SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for n courses.(0<n<8)

  • SDMProcedure or surgery

    Making the decision about the cycle of neoadjuvant chemotherapy with shared decision making

  • SurgeryProcedure or surgery

    Radical surgery with D2 lymph node dissection

  • ACTDrug

    SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for 8-n courses.(0<n<8)

  • QuestionnaireOther

    MAPPIN'SDM questionnaire, the control performance card, the care questionnaire, the decisional conflict questionnaire, the decisional regret questionnaire, the questionnaire of the reason for stopping neoadjuvant chemotherapy

Study groups in NCT03413514
Study groupRoleWhat they receive
experiment groupExperimentalNeoadjuvant chemotherapy(NACT) are performed for locally advanced gastric cancer. The clinical response is evaluated by MRI and enhanced CT. The cycle of neoadjuvant chemotherapy is decided by the doctor and the patents together with shared decision making(SDM). Radical gastrectomy with D2 lymph node dissection are performed after neoadjuvant chemotherapy. Adjuvant chemotherapy(ACT) are preformed after surgery. Questionnaires are preformed to evaluate the involvement emotion and reason for the decision of stopping neoadjuvant chemotherapy.
Receives: Drug: NACT; Procedure: SDM; Procedure: Surgery; Drug: ACT; Other: Questionnaire

What is being measured

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

  1. The cycle of neoadjuvant chemotherapy

    The cycle of neoadjuvant chemotherapy means the maximal cycle of effective neoadjuvant chemotherapy. The effective means no disease progress by image diagnosis

    Measured: 18months

Secondary outcomes (12)

  1. The clinical response rate

    The clinical response is evaluated by CT/MRI according to the Response Evaluation Criteria In Solid Tumors (RECIST)1.1

    Measured: 18 months

  2. The completion rate of perioperative chemotherapy

    The completion rate of perioperative chemotherapy means the patient completed the 8 cycles of perioperative chemotherapy as planned (n cycles of neoadjuvant chemotherapy and 8-n cycles of adjuvant chemotherapy)

    Measured: 18 months

  3. The progressive disease rate

    The progressive disease during neoadjuvant chemotherapy with shared decision making is is evaluated by CT/MRI according to the Response Evaluation Criteria In Solid Tumors (RECIST)1.1

    Measured: 18 months

  4. The pathological response

    The pathological response during neoadjuvant chemotherapy with shared decision making is evaluated according to the tumor regression grade of NCCN guideline.

    Measured: 18 months

  5. The pathological complete response

    The pathological complete response is defined as ypT0N0M0

    Measured: 18months

  6. The adverse event of chemotherapy

    The adverse event of chemotherapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v.3

    Measured: 18 months

  7. Surgical morbidity

    Surgical morbidity is defined as the events which occurs with-in postoperative 30 days, extension of hospitalization and re-hospitalization. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name, date of on-set (postoperatively), grade on Clavien-Dindo Classification and treatment for complication.

    Measured: 18 months

  8. The 3-year progression-free survival

    In terms of locally advanced gastric cancer, to evaluate the progression-free survival rate in gastrectomy with D2 lymph node dissection at postoperative 3 years

    Measured: 48months

  9. The cTNM,ycTNM,ypTNM stage

    The cTNM stage, ycTNM stage and ypTNM stage is defined according to the 8th TNM stage.

    Measured: 60months

  10. The decisional conflicts

    The decisional conflicts is evaluated by Decisional Conflict Scale

    Measured: 12months

  11. The decisional regrets

    The decisional regrets is evaluated by Decision Regret Scale

    Measured: 12months

  12. The involvement of patients during the shared decision making

    The involvement of patients during the shared decision making is evaluated by MAPPIN'SDM questionnaire

    Measured: 12months

Timeline

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

  1. First posted29 Jan 2018
  2. Study start3 Jan 2018
  3. Primary completion3 Jan 2019 (estimated)
  4. Study completion3 Jan 2023 (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 N/A
Primary purpose
Treatment
Intervention model
Sequential
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03413514
Sponsor's protocol ID
2017YJZ51
Acronym
RECOMMEND
Status last verified
Jan 2018
First submitted
14 Jan 2018
Last updated
29 Jan 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

    PubMed 25651787

  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

    PubMed 26808342

  • Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available.

    PubMed 27342689

  • Yoshikawa T, Tanabe K, Nishikawa K, Ito Y, Matsui T, Kimura Y, Hirabayashi N, Mikata S, Iwahashi M, Fukushima R, Takiguchi N, Miyashiro I, Morita S, Miyashita Y, Tsuburaya A, Sakamoto J. Induction of a pathological complete response by four courses of neoadjuvant chemotherapy for gastric cancer: early results of the randomized phase II COMPASS trial. Ann Surg Oncol. 2014 Jan;21(1):213-9. doi: 10.1245/s10434-013-3055-x. Epub 2013 Jul 10.

    PubMed 23838904

  • Aoyama T, Nishikawa K, Fujitani K, Tanabe K, Ito S, Matsui T, Miki A, Nemoto H, Sakamaki K, Fukunaga T, Kimura Y, Hirabayashi N, Yoshikawa T. Early results of a randomized two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with two and four courses of cisplatin/S-1 and docetaxel/cisplatin/S-1 as neoadjuvant chemotherapy for locally advanced gastric cancer. Ann Oncol. 2017 Aug 1;28(8):1876-1881. doi: 10.1093/annonc/mdx236.

    PubMed 28486692

  • Schulz C, Kullmann F, Kunzmann V, Fuchs M, Geissler M, Vehling-Kaiser U, Stauder H, Wein A, Al-Batran SE, Kubin T, Schafer C, Stintzing S, Giessen C, Modest DP, Ridwelski K, Heinemann V. NeoFLOT: Multicenter phase II study of perioperative chemotherapy in resectable adenocarcinoma of the gastroesophageal junction or gastric adenocarcinoma-Very good response predominantly in patients with intestinal type tumors. Int J Cancer. 2015 Aug 1;137(3):678-85. doi: 10.1002/ijc.29403. Epub 2015 Feb 25.

    PubMed 25530271

  • Kane HL, Halpern MT, Squiers LB, Treiman KA, McCormack LA. Implementing and evaluating shared decision making in oncology practice. CA Cancer J Clin. 2014 Nov-Dec;64(6):377-88. doi: 10.3322/caac.21245. Epub 2014 Sep 8.

    PubMed 25200391

  • Fried TR. Shared Decision Making--Finding the Sweet Spot. N Engl J Med. 2016 Jan 14;374(2):104-6. doi: 10.1056/NEJMp1510020. No abstract available.

    PubMed 26760081

Questions about this trial

What is this clinical trial studying?

A study testing NACT, SDM and Surgery in people with Gastric Cancer, run by Peking 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 3 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 29 Jan 2018. 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.

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 Ziyu Li, MD (86-010-8819-6605, ligregory@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The cycle of neoadjuvant chemotherapy (time frame: 18months). 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 NCT03413514, which also lists 8 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 29 Jan 2018.

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RECOMMEND Clinical Trial NCT03413514 | AzTrials