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Esophageal Squamous Cell CarcinomaPhase 2NCT03660449

Moderately Hypofractionated Conformal Radiation Combined With S-1 for Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Moderately hypofractionated conformal radiation combined With S-1 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
Search all trials

Trial summary

This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma. 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?
Moderately hypofractionated conformal radiation combined With S-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteChina
Study dates
1 Oct 2017to 30 Jul 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
  • Inoperable stage II-IVa (UICC 2002; sixth edition), confirmed by contrast enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography.
  • Eastern Cooperative Oncology Group (ECOG) performance status 1-2
  • Estimated life expectancy of at least 12 weeks
  • Charlson comorbidity index.4
  • Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1
Show all 10Show fewer
  • Adequate renal function: creatinine grade 0 or 1
  • Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase <2 times of the upper normal limit
  • Weight loss.15% during 6 months prior to diagnosis
  • Forced expiratory volume second.1L

Who cannot join

  • Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ
  • Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy
  • Contraindication for chemotherapy or radiotherapy
  • Malignant pleural or pericardial effusion
  • Women in pregnancy or lactation period
  • Women who has the probability of pregnancy without contraception
Show all 12Show fewer
  • Weight loss≥15% during 3 months prior to diagnosis
  • In other clinical trials within 30 days
  • Addicted in drugs or alcohol, AIDS patients
  • Uncontrollable seizure or psychotic patients without self-control ability
  • Severe allergy or idiosyncrasy
  • 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 S-1 Plus Moderately Hypofractionated Conformal Radiation for Esophageal Squamous Cell Carcinoma

This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma.

Read the detailed description

This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma.

All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date on which disease progresses. Progression-free survival will be calculated and compared using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.

Being tested
Moderately hypofractionated conformal radiation combined With S-1
Keywords
Esophageal Squamous Cell Carcinoma, Hypofractionated Conformal Radiation, S-1
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.

  • Moderately hypofractionated conformal radiation combined With S-1Combination product

    All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV.

Study groups in NCT03660449
Study groupRoleWhat they receive
ExperimentExperimentalAll patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV.
Receives: Combination Product: Moderately hypofractionated conformal radiation combined With S-1

What is being measured

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

  1. Progression-Free Survival

    Measured: 3 years

Secondary outcomes (3)

  1. Overall Survival

    Measured: 3 years

  2. rate of grade 3-4 radiation esophagitis

    Measured: 1 year

  3. rate of grade 3-4 radiation pneumonitis

    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 posted6 Sep 2018
  2. Study start1 Oct 2017
  3. Primary completion30 Jul 2022
  4. Study completion30 Jul 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
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03660449
Sponsor's protocol ID
GASTO-1045
Status last verified
Oct 2022
First submitted
4 Sep 2018
Last updated
26 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002 Mar 1;20(5):1167-74. doi: 10.1200/JCO.2002.20.5.1167.

    PubMed 11870157

  • Gaspar LE, Winter K, Kocha WI, Coia LR, Herskovic A, Graham M. A phase I/II study of external beam radiation, brachytherapy, and concurrent chemotherapy for patients with localized carcinoma of the esophagus (Radiation Therapy Oncology Group Study 9207): final report. Cancer. 2000 Mar 1;88(5):988-95.

    PubMed 10699886

  • Fan TY, Xing J, Lu J, Liu TH, Xu M, Zhang YJ, Shao Q, Li JB, Yu JM. Phase I/II study of induction chemotherapy plus concurrent chemotherapy and SMART-IMRT-based radiotherapy in locoregionally-advanced nasopharyngeal cancer. Oncol Lett. 2013 Mar;5(3):889-895. doi: 10.3892/ol.2013.1137. Epub 2013 Jan 15.

    PubMed 23426016

  • Koom WS, Kim TH, Shin KH, Pyo HR, Kim JY, Kim DY, Yoon M, Park SY, Lee DH, Ryu JS, Jung YS, Lee SH, Cho KH. SMART (simultaneous modulated accelerated radiotherapy) for locally advanced nasopharyngeal carcinomas. Head Neck. 2008 Feb;30(2):159-69. doi: 10.1002/hed.20667.

    PubMed 17764088

  • Butler EB, Teh BS, Grant WH 3rd, Uhl BM, Kuppersmith RB, Chiu JK, Donovan DT, Woo SY. Smart (simultaneous modulated accelerated radiation therapy) boost: a new accelerated fractionation schedule for the treatment of head and neck cancer with intensity modulated radiotherapy. Int J Radiat Oncol Biol Phys. 1999 Aug 1;45(1):21-32. doi: 10.1016/s0360-3016(99)00101-7.

    PubMed 10477002

  • Welsh J, Palmer MB, Ajani JA, Liao Z, Swisher SG, Hofstetter WL, Allen PK, Settle SH, Gomez D, Likhacheva A, Cox JD, Komaki R. Esophageal cancer dose escalation using a simultaneous integrated boost technique. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):468-74. doi: 10.1016/j.ijrobp.2010.10.023. Epub 2010 Dec 1.

    PubMed 21123005

  • Porceddu SV, Rosser B, Burmeister BH, Jones M, Hickey B, Baumann K, Gogna K, Pullar A, Poulsen M, Holt T. Hypofractionated radiotherapy for the palliation of advanced head and neck cancer in patients unsuitable for curative treatment--"Hypo Trial". Radiother Oncol. 2007 Dec;85(3):456-62. doi: 10.1016/j.radonc.2007.10.020. Epub 2007 Nov 26.

    PubMed 18036689

  • Agarwal JP, Nemade B, Murthy V, Ghosh-Laskar S, Budrukkar A, Gupta T, D'Cruz A, Pai P, Chaturvedi P, Dinshaw K. Hypofractionated, palliative radiotherapy for advanced head and neck cancer. Radiother Oncol. 2008 Oct;89(1):51-6. doi: 10.1016/j.radonc.2008.06.007. Epub 2008 Jul 21.

    PubMed 18649963

  • Hama Y, Uematsu M, Shioda A, Suda A, Aida S, Kusano S. Severe complications after hypofractionated high dose rate intracavitary brachytherapy following external beam irradiation for oesophageal carcinoma. Br J Radiol. 2002 Mar;75(891):238-42. doi: 10.1259/bjr.75.891.750238.

    PubMed 11932217

  • Aggarwal A, Harrison M, Glynne-Jones R, Sinha-ray R, Cooper D, Hoskin PJ. Combination external beam radiotherapy and intraluminal brachytherapy for non-radical treatment of oesophageal carcinoma in patients not suitable for surgery or chemoradiation. Clin Oncol (R Coll Radiol). 2015 Jan;27(1):56-64. doi: 10.1016/j.clon.2014.09.001. Epub 2014 Oct 11.

    PubMed 25306490

  • Song YP, Ma JB, Hu LK, Zhou W, Chen EC, Zhang W. Phase I/II study of hypofractioned radiation with three-dimensional conformal radiotherapy for clinical T3-4N0-1M0 stage esophageal carcinoma. Technol Cancer Res Treat. 2011 Feb;10(1):25-30. doi: 10.7785/tcrt.2012.500176.

    PubMed 21214285

  • Ma JB, Wei L, Chen EC, Qin G, Song YP, Chen XM, Hao CG. Moderately hypofractionated conformal radiation treatment of thoracic esophageal carcinoma. Asian Pac J Cancer Prev. 2012;13(8):4163-7. doi: 10.7314/apjcp.2012.13.8.4163.

    PubMed 23098423

  • Sato Y, Takayama T, Sagawa T, Okamoto T, Miyanishi K, Sato T, Araki H, Iyama S, Abe S, Murase K, Takimoto R, Nagakura H, Hareyama M, Kato J, Niitsu Y. A phase I/II study of nedaplatin and 5-fluorouracil with concurrent radiotherapy in patients with esophageal cancer. Cancer Chemother Pharmacol. 2006 Nov;58(5):570-6. doi: 10.1007/s00280-006-0193-x. Epub 2006 Feb 4.

    PubMed 16463059

  • Kodaira T, Fuwa N, Kamata M, Furutani K, Tachibana H, Yamazaki T. Single-institute phase I/II trial of alternating chemoradiotherapy with 5-FU and nedaplatin for esophageal carcinoma. Anticancer Res. 2006 Jan-Feb;26(1B):471-8.

    PubMed 16739307

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Moderately hypofractionated conformal radiation combined With S-1 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 10 inclusion and 12 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 26 Oct 2022. 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?

Progression-Free Survival (time frame: 3 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 NCT03660449, which also lists 18 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 26 Oct 2022.

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