NCT02296658

Brief Summary

The aim of this phase II trial was to evaluate the feasibility, efficacy and tolerability of intensity-modulated radiotherapy combined with S-1 based chemotherapy in patients with pathologically positive lymph node after completely resected gastric cancer. Furthermore, the investigators sought to compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning for gastric cancer as adjuvant radiotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

November 18, 2014

Last Update Submit

November 19, 2014

Conditions

Stomach NeoplasmsChemoradiotherapy, AdjuvantRadiotherapy, Intensity-Modulated

Outcome Measures

Primary Outcomes (4)

  • Disease free survival

    3 years

  • Locoregional recurrence free survival

    3 years

  • Overall survival

    3 years

  • Distant metastasis free survival

    3 years

Secondary Outcomes (1)

  • Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0

    during treatment and within the first 30 days after completion of chemoradiotherapy

Other Outcomes (1)

  • Comparison of dosimetric differences between radiation techniques

    1 year

Study Arms (1)

S-1 based chemoradiotherapy

EXPERIMENTAL

S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.

Radiation: intensity-modulated radiotherapyDrug: S-1

Interventions

intensity-modulated radiotherapyRADIATION

A total irradiation dose of 45 Gy was delivered in daily 1.8-Gy fractions (5 days a week over 5 weeks) to all patients.

S-1 based chemoradiotherapy
S-1DRUG

S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy.

S-1 based chemoradiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically proven positive lymph node gastric adenocarcinoma in patients undergoing R0 resection
  • Any prior chemotherapy is allowed in this protocol
  • No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation
  • No prior abdominal or pelvic radiotherapy
  • Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
  • Patients must have normal organ and marrow function as defined below:
  • Leukocytes greater than or equal to 3,000 G/L
  • Platelets: greater than or equal to 100,000/mm3
  • Hemoglobin:greater than or equal to 10g/L
  • Total bilirubin: within normal institutional limits
  • AST/ALT: less than or equal to 1.5 times the upper limit
  • Creatinine within normal upper limits
  • Informed consent

You may not qualify if:

  • Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
  • With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation
  • History of allergic reactions attributed to similar chemical or biologic complex to S-1
  • Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
  • History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
  • History of prior radiation to the abdomen
  • Pregnant or lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Radiotherapy, Intensity-ModulatedS 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Central Study Contacts

Jing Jin, MD

CONTACT

+8613601365130jingjin1025@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cancer Hospital

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 20, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

CN(1)