Trial · NCT01333033

PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy

NCT01333033, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2021-11-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy. Trials, record NCT01333033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01333033

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Trial

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

Title: PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy
NCT number: NCT01333033
Status: Completed
Phases: Phase 2
Enrollment: 257 participants, actual
Lead sponsor: Alliance for Clinical Trials in Oncology
Conditions: Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer
Interventions: Oxaliplatin, Leucovorin Calcium, Fluorouracil, Carboplatin, Paclitaxel, Positron Emission Tomography, Computed Tomography, Radiation Therapy
First posted: 2011-04-11
Last updated: 2023-04-13
Results first posted: 2021-11-03

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Complete Pathological Response (pCR) of PET/CT Non-responders	Up to 5 years	The primary endpoint of this study is the percentage of PET/CT non-responders within each induction treatment group reporting a pCR. A pCR is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor.
Secondary	PET/CT Response Between Treatment Arms	Up to 5 years	A PET/CT response to induction therapy is defined as metabolic activity of the tumor decreasing by \>=35%, as measured by maximum standardized uptake value (SUVmax).
Secondary	pCR Compared Between Induction Treatment Arms Among PET/CT Responders	Up to 5 years	A PET/CT response to induction therapy is defined as metabolic activity of the tumor decreasing by \>=35%, as\> \>\> \>\> \>\> measured by maximum standardized uptake value (SUVmax). A pCR is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor.
Secondary	pCR Compared Among Non-responders Between Induction Treatment Arms if Treatment Regimens Are Found to be Efficacious	Up to 5 years	A Complete Pathological Response (pCR) is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor. A non-responder was defined as having a PET/CT SUV (standard uptake value) decrease of less than 35% after induction.\> \>\>\> \> \>\>\> Among the patients who completed induction therapy and did not respond, the percentage of patients reporting a pCR in each arm were compared.
Secondary	Progression Free Survival (PFS) Among PET/CT Non-responders Within Each Induction Treatment Group	Up to 5 years	A non-responder was defined as having a PET/CT SUV (standard uptake value) decrease of less than 35% after induction. Among the patients who completed induction therapy and did not respond, the progression free survival in each arm were compared. PFS will be measured from study entry until documented progression or death from any cause. PFS will be estimated using the method of Kaplan and Meier.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Complete Pathological Response (pCR) of PET/CT Non-responders	Up to 5 years	All eligible patients that registered to treatment and reported no PET/CT response to induction treatment were included in this endpoint.	percentage of participants with a pCR	NUMBER
SECONDARY	PET/CT Response Between Treatment Arms	Up to 5 years	All participants that were assessed for an induction response are included in this analysis.	percentage of patients with a response	NUMBER
SECONDARY	pCR Compared Between Induction Treatment Arms Among PET/CT Responders	Up to 5 years	All eligible patients that were assessed as a PET responder by induction were included in this analysis.	percentage of participants with a pCR	NUMBER
SECONDARY	pCR Compared Among Non-responders Between Induction Treatment Arms if Treatment Regimens Are Found to be Efficacious	Up to 5 years	All patients who completed induction therapy and were classified as a non-responder were included in this analysis.	percentage of participants with a pCR	NUMBER
SECONDARY	Progression Free Survival (PFS) Among PET/CT Non-responders Within Each Induction Treatment Group	Up to 5 years	All patients that began induction therapy and did not report a response were included in this analysis.	months	MEDIAN

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Complete Pathological Response (pCR) of PET/CT Non-responders	FOLFOX Non-Responder	17.95	95% Confidence Interval 7.54 to 33.53	percentage of participants with a pCR
Complete Pathological Response (pCR) of PET/CT Non-responders	CP Non-Responder	20	95% Confidence Interval 10.03 to 33.72	percentage of participants with a pCR
PET/CT Response Between Treatment Arms	FOLFOX Regimen	64.86	95% Confidence Interval 55.23 to 73.69	percentage of patients with a response
PET/CT Response Between Treatment Arms	CP (Carboplatin + Paclitaxel + Radiation)	56.14	95% Confidence Interval 46.54 to 65.42	percentage of patients with a response
pCR Compared Between Induction Treatment Arms Among PET/CT Responders	FOLFOX Responder	40.28	95% Confidence Interval 28.88 to 52.5	percentage of participants with a pCR
pCR Compared Between Induction Treatment Arms Among PET/CT Responders	CP (Carboplatin + Paclitaxel + Radiation) Responder	14.06	95% Confidence Interval 6.64 to 25.02	percentage of participants with a pCR
pCR Compared Among Non-responders Between Induction Treatment Arms if Treatment Regimens Are Found to be Efficacious	FOLFOX Regimen Non-Responders	17.95	95% Confidence Interval 7.54 to 33.53	percentage of participants with a pCR
pCR Compared Among Non-responders Between Induction Treatment Arms if Treatment Regimens Are Found to be Efficacious	CP (Carboplatin + Paclitaxel + Radiation) Non-Responders	20	95% Confidence Interval 10.03 to 33.72	percentage of participants with a pCR
Progression Free Survival (PFS) Among PET/CT Non-responders Within Each Induction Treatment Group	FOLFOX Regimen Non-Responder	NA	95% Confidence Interval 27.8 to NA	months
Progression Free Survival (PFS) Among PET/CT Non-responders Within Each Induction Treatment Group	CP Non-Responder	33.4	95% Confidence Interval 17.2 to NA	months

Source ClinicalTrials.gov

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	FOLFOX Responder	72
Overall Study	STARTED	FOLFOX Non-Responder	39
Overall Study	STARTED	CP Responder	64
Overall Study	STARTED	CP Non-Responder	50
Overall Study	STARTED	CP No Cross-over	14
Overall Study	STARTED	FOLFOX6 No Cross-over	18
Overall Study	COMPLETED	FOLFOX Responder	72
Overall Study	COMPLETED	FOLFOX Non-Responder	39
Overall Study	COMPLETED	CP Responder	64
Overall Study	COMPLETED	CP Non-Responder	50

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events948

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	Events
other	Anemia	Blood and lymphatic system disorders	FOLFOX Responder	6	72	19
other	Anemia	Blood and lymphatic system disorders	FOLFOX Non-Responder	7	39	11
other	Anemia	Blood and lymphatic system disorders	CP Responder	5	64	9
other	Anemia	Blood and lymphatic system disorders	CP Non-Responder	10	49	15
other	Anemia	Blood and lymphatic system disorders	CP No Cross-over	0	9	0
other	Anemia	Blood and lymphatic system disorders	FOLFOX No Cross-over	0	5	0
other	Blood and lymph sys disorders - Oth Spec	Blood and lymphatic system disorders	FOLFOX Responder	1	72	1
other	Blood and lymph sys disorders - Oth Spec	Blood and lymphatic system disorders	FOLFOX Non-Responder	1	39	1
other	Blood and lymph sys disorders - Oth Spec	Blood and lymphatic system disorders	CP Responder	2	64	6
other	Blood and lymph sys disorders - Oth Spec	Blood and lymphatic system disorders	CP Non-Responder	0	49	0

1 to 10 of 948Source ClinicalTrials.gov

See all 948 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	FOLFOX Responder	3	72
Total, all-cause mortality	FOLFOX Non-Responder	1	39
Total, all-cause mortality	CP Responder	2	64
Total, all-cause mortality	CP Non-Responder	4	49
Total, all-cause mortality	CP No Cross-over	0	9
Total, all-cause mortality	FOLFOX No Cross-over	0	5
Total, other adverse events	FOLFOX Responder	72	72
Total, other adverse events	FOLFOX Non-Responder	38	39
Total, other adverse events	CP Responder	63	64
Total, other adverse events	CP Non-Responder	46	49

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28078107	DERIVED	PubMed
34077237	DERIVED	PubMed

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
U10CA180821	Alliance for Clinical Trials in Oncology Operations Center	Galanis, Evanthia; Hahn, Olwen; Kozono, David	ALLIANCE NCTN FOUNDATION	NATIONAL CANCER INSTITUTE	2014 to 2026

Source NIH RePORTER

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/NCT01333033

GET https://conductscience.org/api/trials/v1/NCT01333033/events?page=2

API reference For AI assistants