Trial · NCT01498289

S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer

NCT01498289, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2019-08-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer. Trials, record NCT01498289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01498289

On this page

Trial

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

Title: S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer
NCT number: NCT01498289
Status: Completed
Phases: Phase 2
Enrollment: 213 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer, Gastric Cancer
Interventions: FOLFOX regimen, docetaxel, fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin
First posted: 2011-12-23
Last updated: 2019-11-07
Results first posted: 2019-08-29

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS) in High-ERCC1 Patients	Up to 3 years after registration	Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.
Primary	PFS in Low-ERCC1 Participants	Up to 3 years after registration	Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.
Primary	Overall Survival (OS)	Up to 3 years after registration	OS is the length of time between protocol registration and patient death
Secondary	Overall Response Rate (ORR)	Up to 3 years after registration	ORR (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary	PFS Variation by ERCC1	up to 3 years after registration	Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first. Participants were divided into subgroups according to ERCC1 quartiles to assess whether the differences in PFS between the two treatment arms varied by ERCC1 levels.
Secondary	Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Duration of treatment and follow up until death or 3 years post registration	Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival (PFS) in High-ERCC1 Patients	Up to 3 years after registration	Eligible and analyzable participants with ERCC1 level \>= 1.7	months	MEDIAN
PRIMARY	PFS in Low-ERCC1 Participants	Up to 3 years after registration	Eligible and analyzable participants with ERCC1 level \< 1.7	months	MEDIAN
PRIMARY	Overall Survival (OS)	Up to 3 years after registration	Eligible and analyzable participants	months	MEDIAN
SECONDARY	Overall Response Rate (ORR)	Up to 3 years after registration	Participants with measurable disease	percentage of evaluable participants	NUMBER
SECONDARY	PFS Variation by ERCC1	up to 3 years after registration	Eligible and analyzable participants were divided into quartiles based on ERCC1 levels.	months	MEDIAN
SECONDARY	Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Duration of treatment and follow up until death or 3 years post registration	Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment	Participants	NUMBER

Source ClinicalTrials.gov

Results by group148

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

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival (PFS) in High-ERCC1 Patients	Arm I FOLFOX		4.7	95% Confidence Interval 2.1 to 8.7	months
Progression-free Survival (PFS) in High-ERCC1 Patients	Arm II IT		5.3	95% Confidence Interval 0.9 to 11.5	months
PFS in Low-ERCC1 Participants	Arm I		5.9	95% Confidence Interval 4.1 to 7.1	months
PFS in Low-ERCC1 Participants	Arm II		2.8	95% Confidence Interval 1.7 to 4.1	months
Overall Survival (OS)	Arm I		11.4	95% Confidence Interval 9.8 to 13.5	months
Overall Survival (OS)	Arm II		8.7	95% Confidence Interval 6.0 to 10.1	months
Overall Response Rate (ORR)	Arm I		42	95% Confidence Interval 31 to 53	percentage of evaluable participants
Overall Response Rate (ORR)	Arm II		30	95% Confidence Interval 20 to 39	percentage of evaluable participants
PFS Variation by ERCC1	Arm I	Q1 ERCC1 (0.20-0.80)	5.6	95% Confidence Interval 2.4 to 8.3	months
PFS Variation by ERCC1	Arm II	Q1 ERCC1 (0.20-0.80)	2.8	95% Confidence Interval 1.4 to 4.9	months

1 to 10 of 148Source ClinicalTrials.gov

See all 148 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I	98
Overall Study	STARTED	Arm II	104
Overall Study	Participants Assessed for AEs	Arm I	91
Overall Study	Participants Assessed for AEs	Arm II	98
Overall Study	COMPLETED	Arm I	0
Overall Study	COMPLETED	Arm II	0
Overall Study	NOT COMPLETED	Arm I	98
Overall Study	NOT COMPLETED	Arm II	104

Source ClinicalTrials.gov

Adverse events536

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

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Arm I FOLFOX	65	91
other	Anemia	Blood and lymphatic system disorders	Arm II IT	70	98
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm I FOLFOX	1	91
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm II IT	6	98
other	Leukocytosis	Blood and lymphatic system disorders	Arm I FOLFOX	0	91
other	Leukocytosis	Blood and lymphatic system disorders	Arm II IT	2	98
other	Lymph node pain	Blood and lymphatic system disorders	Arm I FOLFOX	1	91
other	Lymph node pain	Blood and lymphatic system disorders	Arm II IT	0	98
other	Atrial fibrillation	Cardiac disorders	Arm I FOLFOX	1	91
other	Atrial fibrillation	Cardiac disorders	Arm II IT	0	98

1 to 10 of 536Source ClinicalTrials.gov

See all 536 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I FOLFOX	89	98
Total, all-cause mortality	Arm II IT	94	104
Total, other adverse events	Arm I FOLFOX	88	91
Total, other adverse events	Arm II IT	95	98
Total, serious adverse events	Arm I FOLFOX	7	91
Total, serious adverse events	Arm II IT	17	98

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Arm I FOLFOX vs Arm II IT: deaths from any cause	Trial comparisons
Arm I FOLFOX vs Arm II IT: serious adverse events	Trial comparisons

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/NCT01498289

GET https://conductscience.org/api/trials/v1/NCT01498289/results?page=2

API reference For AI assistants