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Trial · NCT01291407

A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer

NCT01291407, Phase 1, Completed, Chinese Academy of Medical Sciences

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer. Trials, record NCT01291407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01291407

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer
NCT number
NCT01291407
Status
Completed
Phases
Phase 1
Enrollment
27 participants, actual
Lead sponsor
Chinese Academy of Medical Sciences
Conditions
Gastrointestinal Neoplasms, Gastric Cancer
Interventions
S-1, S-1, S-1, S-1, S-1, S-1
First posted
2011-02-08
Last updated
2013-09-18

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTo define dose limited toxicities(DLT) of S-1, peroral BID, in treatment days concurrently with radiation therapy (RT) in locally advanced or recurrent gastric cancer.up to 9 weeks
Dose limited toxicities defined as below: leucopenia ≥4 neutropenia ≥ 4, anemia ≥ 3, thrombocytopenia ≥ 3, alanine aminotransferase/aspartate aminotransferase (AST) ≥ 3, alkaline phosphatase (ALT) ≥ 3, total bilirubin ≥ 3,blood urea nitrogen (BUN)/Cr ≥ 2,non-granular cell decreased fever ≥ 2, nausea/vomiting ≥ 2, fatigue ≥ 3, weight loss ≥ 3, diarrhea ≥ 3, abdominal pain ≥ 3, dysphagia ≥ 3, hand-foot syndrome ≥ 2, neurotoxicity ≥ 2.
SecondaryTo define maximum tolerated dose(MTD) of S-1, peroral BID, in treatment days concurrently with radiation therapyup to 9 weeks
If 1 of 3 patients treated within a S-1 dose level experiences DLTs, 3 more patients will be treated at the same level. If a second patient experiences DLTs, then escalation will be stopped and the MTD is defined as the level below DLT dose level.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers13

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
9422070BACKGROUNDPubMed
9893658BACKGROUNDPubMed
10200776BACKGROUNDPubMed
10545788BACKGROUNDPubMed
10765119BACKGROUNDPubMed
10894878BACKGROUNDPubMed
12114411BACKGROUNDPubMed
12775017BACKGROUNDPubMed
15297391BACKGROUNDPubMed
17978289BACKGROUNDPubMed

1 to 10 of 13

See all 13 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01291407

GET https://conductscience.org/api/trials/v1/NCT01291407/registered