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Esophageal Squamous Cell CarcinomaPhase 2NCT04380480

Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy for Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy in people with Esophageal Squamous Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.

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

This Phase II randomized study is to determine the efficacy of percutaneous endoscopic gastrostomy before definitive concurrent chemoradiotherapy (CCRT) in Patients with Esophageal Squamous Cell Carcinoma(ESCC) by assessing their weight, nutritional status, performance status and treatment response. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteChina
Study dates
1 Feb 2020to 15 Mar 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

  • Histologically confirmed esophageal squamous cell carcinoma
  • Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Estimated life expectancy of at least 6 months
  • No contraindications for chemotherapy or radiotherapy
  • Patients and their family signed the informed consents

Who cannot join

  • Severe gastrointestinal impairment or enteral nutrition intolerance
  • Severe vomiting, gastrointestinal bleeding or intestinal obstruction
  • Severe malnutrition
  • Patients with contraindications for percutaneous endoscopic gastrostomy, including uncorrected coagulopathy or thrombocytopenia, varices caused by portal hypertension, or other gastric diseases
  • Not suitable for this study judged by researchers

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hui Liu

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: A Prospective, Phase II Study of Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy in Patients With Esophageal Squamous Cell Carcinoma

This Phase II randomized study is to determine the efficacy of percutaneous endoscopic gastrostomy before definitive concurrent chemoradiotherapy (CCRT) in Patients with Esophageal Squamous Cell Carcinoma(ESCC) by assessing their weight, nutritional status, performance status and treatment response.

Read the detailed description

This Phase II randomized study is to determine the efficacy of percutaneous endoscopic gastrostomy before definitive concurrent chemoradiotherapy (CCRT) in Patients with Esophageal Squamous Cell Carcinoma(ESCC) by assessing their weight, nutritional status, performance status and treatment response.

All patients will receive definitive radiotherapy combined with three cycles of S-1 (40mg/2, BID, po) on D1-14, D22-35, D43-56. The primary endpoint is percentage of recent weight loss at the end of CCRT. The secondary endpoints are nutrition status, objective response rate, overall survival, toxicity and intestinal flora changes in blood, urine and stool specimens.

Being tested
Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy
Keywords
esophageal squamous cell carcinoma, percutaneous endoscopic gastrostomy, concurrent chemoradiotherapy, enteral nutrition support
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomyCombination product

    One or two weeks before CCRT, all patients will undergo a percutaneous endoscopic gastrostomy (PEG) to be administered enteral nutrition support(30-35 kcal/kg of energy, 1.2-1.5g/kg of protein and electrolyte supplementation each day). Nutritional supplements will be administered till 1 month after CCRT.

    All patients will receive definitive radiotherapy combined with three cycles of S-1 (40mg/2, BID, po) on D1-14, D22-35, D43-56.

Study groups in NCT04380480
Study groupRoleWhat they receive
ExperimentExperimentalOne or two weeks before CCRT, all patients will undergo a percutaneous endoscopic gastrostomy (PEG) to be administered enteral nutrition support(30-35 kcal/kg of energy, 1.2-1.5g/kg of protein and electrolyte supplementation each day). Nutritional supplements will be administered till 1 month after CCRT. All patients will receive definitive radiotherapy combined with three cycles of S-1 (40mg/2, BID, po) on D1-14, D22-35, D43-56.
Receives: Combination Product: Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy

What is being measured

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

  1. Percentage of Recent Weight Loss

    Measured: From baseline until the end of concurrent chemoradiotherapy, an average of 8 weeks

Secondary outcomes (8)

  1. Change in nutrition status assessed by blood test

    Change in nutrition status will be assessed by hemoglobin, serum albumin, pre-albumin test. The patient-generated subjective global assessment will also be used to measure patients' nutrition status

    Measured: 1 year

  2. Quality of life measured by WHO Quality of Life-100 questionnaire

    Measured: 1 year

  3. Rate of grade 3-4 radiation esophagitis

    Measured: 1 year

  4. Rate of grade 3-4 radiation pneumonitis，

    Measured: 1 year

  5. Rate of grade 3-4 bone marrow suppression

    Measured: 1 year

  6. Objective response rate

    Measured: 2 months

  7. Overall survival

    Measured: 3 years

  8. Changes of participants' intestinal flora assessed by blood, urine and stool test

    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 posted8 May 2020
  2. Study start1 Feb 2020
  3. Primary completion15 Mar 2022
  4. Study completion15 Mar 2022

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
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04380480
Sponsor's protocol ID
GASTO-1059
Status last verified
Jan 2023
First submitted
21 Mar 2020
Last updated
11 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

  • Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623.

    PubMed 10235156

  • Bozzetti F, Mariani L, Lo Vullo S; SCRINIO Working Group; Amerio ML, Biffi R, Caccialanza G, Capuano G, Correja I, Cozzaglio L, Di Leo A, Di Cosmo L, Finocchiaro C, Gavazzi C, Giannoni A, Magnanini P, Mantovani G, Pellegrini M, Rovera L, Sandri G, Tinivella M, Vigevani E. The nutritional risk in oncology: a study of 1,453 cancer outpatients. Support Care Cancer. 2012 Aug;20(8):1919-28. doi: 10.1007/s00520-012-1387-x.

    PubMed 22314972

  • Clavier JB, Antoni D, Atlani D, Ben Abdelghani M, Schumacher C, Dufour P, Kurtz JE, Noel G. Baseline nutritional status is prognostic factor after definitive radiochemotherapy for esophageal cancer. Dis Esophagus. 2014 Aug;27(6):560-7. doi: 10.1111/j.1442-2050.2012.01441.x. Epub 2012 Oct 26.

    PubMed 23106980

  • Ma L, Luo GY, Ren YF, Qiu B, Yang H, Xie CX, Liu SR, Liu SL, Chen ZL, Li Q, Fu JH, Liu MZ, Hu YH, Ye WF, Liu H. Concurrent chemoradiotherapy combined with enteral nutrition support: a radical treatment strategy for esophageal squamous cell carcinoma patients with malignant fistulae. Chin J Cancer. 2017 Jan 11;36(1):8. doi: 10.1186/s40880-016-0171-6.

    PubMed 28077159

  • Birnstein E, Schattner M. Nutritional Support in Esophagogastric Cancers. Surg Oncol Clin N Am. 2017 Apr;26(2):325-333. doi: 10.1016/j.soc.2016.10.003. Epub 2017 Feb 9.

    PubMed 28279472

  • Yu FJ, Shih HY, Wu CY, Chuang YS, Lee JY, Li HP, Fang PT, Tsai DL, Chou SH, Wu IC. Enteral nutrition and quality of life in patients undergoing chemoradiotherapy for esophageal carcinoma: a comparison of nasogastric tube, esophageal stent, and ostomy tube feeding. Gastrointest Endosc. 2018 Jul;88(1):21-31.e4. doi: 10.1016/j.gie.2017.11.030. Epub 2017 Dec 7.

    PubMed 29225081

  • Lin CH, Liu NJ, Lee CS, Tang JH, Wei KL, Yang C, Sung KF, Cheng CL, Chiu CT, Chen PC. Nasogastric feeding tube placement in patients with esophageal cancer: application of ultrathin transnasal endoscopy. Gastrointest Endosc. 2006 Jul;64(1):104-7. doi: 10.1016/j.gie.2005.12.036.

    PubMed 16813813

  • Margolis M, Alexander P, Trachiotis GD, Gharagozloo F, Lipman T. Percutaneous endoscopic gastrostomy before multimodality therapy in patients with esophageal cancer. Ann Thorac Surg. 2003 Nov;76(5):1694-7; discussion 1697-8. doi: 10.1016/s0003-4975(02)04890-7.

    PubMed 14602314

  • Sofue K, Takeuchi Y, Tsurusaki M, Shibamoto K, Sakamoto N, Kitajima K, Sone M, Sugimura K, Arai Y. Value of Percutaneous Radiologic Gastrostomy for Patients with Advanced Esophageal Cancer. Ann Surg Oncol. 2016 Oct;23(11):3623-3631. doi: 10.1245/s10434-016-5276-2. Epub 2016 May 17.

    PubMed 27188297

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy in people with Esophageal Squamous Cell Carcinoma, 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 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 11 Jan 2023. 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?

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?

Percentage of Recent Weight Loss (time frame: From baseline until the end of concurrent chemoradiotherapy, an average of 8 weeks). 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 NCT04380480, which also lists 10 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 11 Jan 2023.

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