Trial · NCT01362127
Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia
NCT01362127, Phase 2, Completed, Karolinska University Hospital; results first posted 2020-02-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia. Trials, record NCT01362127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01362127
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia
- NCT number
- NCT01362127
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 181 participants, actual
- Lead sponsor
- Karolinska University Hospital
- Conditions
- Carcinoma, Squamous Cell, Adenocarcinoma of the Esophagus and Gastric Cardia
- Interventions
- Chemotherapy, Radiochemotherapy
- First posted
- 2011-05-27
- Last updated
- 2020-02-26
- Other registries' IDs
- eudract:2006-001785-16
- Results first posted
- 2020-02-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia. | Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy. | Chireac tumour regression grade |
| Secondary | Safety of Respective Neoadjuvant Therapies. | Five years follow up | Safety profile of carrying out radical surgery after respective neoadjuvant therapy. |
| Secondary | HRQOL and Swallowing Function | Entry study up to Five years follow up | The European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 and disease specific questionnaires (QLQ-OES24/OG25). All items included in the questionnaires are analysed and also separate analysis of dysphagia questionnaires for oesophageal cancer were used, both clinically and psychometrically validated. All questions have four response alternatives (1, not at all; 2:a little, 3: quite a bit, 4: very much), except global scales which comprise seven response alternatives from poor to excellent. Questionnaire responses were transformed lineraly into scores ranging from 0 to 100 according to the EORTC scoring manual. A higher score indicates either more symotoms or better function, depending on the question. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia. | Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety of Respective Neoadjuvant Therapies. | Five years follow up | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | HRQOL and Swallowing Function | Entry study up to Five years follow up | Number of patients who responded to quality of Life instruments the EORTC QLQ-C30 and the oesophageal specific instrument | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia. | Radiochemotherapy | 22 | Participants | ||
| Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia. | Chemotherapy | 7 | Participants | ||
| Safety of Respective Neoadjuvant Therapies. | Radiochemotherapy | 79 | Participants | ||
| Safety of Respective Neoadjuvant Therapies. | Chemotherapy | 81 | Participants | ||
| HRQOL and Swallowing Function | Radiochemotherapy | Mean global QoL | 67 | 95% Confidence Interval 62 to 72 | units on a scale |
| HRQOL and Swallowing Function | Chemotherapy | Mean global QoL | 69 | 95% Confidence Interval 63 to 74 | units on a scale |
| HRQOL and Swallowing Function | Radiochemotherapy | Dysphagia score all | 27 | 95% Confidence Interval 20 to 34 | units on a scale |
| HRQOL and Swallowing Function | Chemotherapy | Dysphagia score all | 31 | 95% Confidence Interval 24 to 39 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Radiochemotherapy | 90 | |
| Overall Study | STARTED | Chemotherapy | 91 | |
| Overall Study | COMPLETED | Radiochemotherapy | 90 | |
| Overall Study | COMPLETED | Chemotherapy | 91 | |
| Overall Study | NOT COMPLETED | Radiochemotherapy | 0 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 0 |
Source ClinicalTrials.gov
Adverse events20
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 |
|---|---|---|---|---|---|---|
| serious | SAE | Investigations | Radiochemotherapy | 57 | 90 | 57 |
| serious | SAE | Investigations | Chemotherapy | 41 | 91 | 41 |
| serious | Infection | Infections and infestations | Radiochemotherapy | 5 | 90 | 5 |
| serious | Infection | Infections and infestations | Chemotherapy | 5 | 91 | 5 |
| serious | Nausea and vomiting | Gastrointestinal disorders | Radiochemotherapy | 6 | 90 | 6 |
| serious | Nausea and vomiting | Gastrointestinal disorders | Chemotherapy | 2 | 91 | 2 |
| serious | Nutritional deficiency | Metabolism and nutrition disorders | Radiochemotherapy | 13 | 90 | 13 |
| serious | Nutritional deficiency | Metabolism and nutrition disorders | Chemotherapy | 13 | 91 | 13 |
| serious | Gastrointestinal symptoms | Gastrointestinal disorders | Radiochemotherapy | 5 | 90 | 5 |
| serious | Gastrointestinal symptoms | Gastrointestinal disorders | Chemotherapy | 1 | 91 | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Radiochemotherapy | ||
| Total, all-cause mortality | Chemotherapy | ||
| Total, other adverse events | Radiochemotherapy | 0 | 90 |
| Total, other adverse events | Chemotherapy | 0 | 91 |
| Total, serious adverse events | Radiochemotherapy | 57 | 90 |
| Total, serious adverse events | Chemotherapy | 41 | 91 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Radiochemotherapy vs Chemotherapy: Safety of Respective Neoadjuvant Therapies. | Trial comparisons |
| Radiochemotherapy vs Chemotherapy: Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia. | Trial comparisons |
| Radiochemotherapy vs Chemotherapy: 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.
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/NCT01362127
GET https://conductscience.org/api/trials/v1/NCT01362127/registered