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Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia (NeoRes)

Primary Purpose

Carcinoma, Squamous Cell, Adenocarcinoma of the Esophagus and Gastric Cardia

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Chemotherapy
Radiochemotherapy
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell focused on measuring Histologically confirmed squamos cell carcinoma or adenocarcinoma of the esophagus and gastric cardia.Suitable for surgery.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically verified squamos cell carcinoma, adenocarcinoma of the esopohagus or gastric cardia (type II)
  • Tumor located in cervical oesophagus, not requiring laryngo-esophagectomy. Patients with performance status 0-1 axxording to WHO scale and with resectable tumours, as assessed at the prerandomisation evaluation
  • Adequate haemotological function, defined as having WBC > 3 x 10(9)/litre and platelets > 100 x 10 (9)/litre.
  • Adequate renal function defined as having normal serum creatinine level and/or calculated glomerular filtration rate > 60 ml/min.
  • Tumour stage: T1Ni, T2N0, T2N1, T3N0, T3N1, M1a

Exclusion Criteria:

  • Pregnancy and/or lactation. Women of childbearing ages can be included and provided that adequate contraceptive methods are used
  • Patients with diabetes complications (e.g. rethinopathy, neuropathy) as well as patients with uncontrolled cardiac disease or myocard infarction within 12 months are considered unsuitable for chemoradiotherapy.
  • Concomitant malignancy (< 5 years since diagnosis) that can interfere the interpretation of study results, ongoing antitumoral treatment.
  • Patients being unable tom comply with the protocol
  • Tumor stage T1 N0, T4 NX or TXNXM1b

Sites / Locations

  • Upper Digestive Diseases. Department of surgery, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Radiochemotherapy

Chemotherapy

Arm Description

Arm I: Radiochemotherapy + Surgery

Arm II: Chemotherapy + surgery

Outcomes

Primary Outcome Measures

Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia.
Chireac tumour regression grade

Secondary Outcome Measures

Safety of Respective Neoadjuvant Therapies.
Safety profile of carrying out radical surgery after respective neoadjuvant therapy.
HRQOL and Swallowing Function
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.

Full Information

First Posted
May 26, 2011
Last Updated
February 25, 2020
Sponsor
Karolinska University Hospital
Collaborators
University Hospital, Umeå, Region Örebro County, Sahlgrenska University Hospital, Sweden, Ullevaal University Hospital, Haukeland University Hospital, Oslo University Hospital, St. Olavs Hospital, Malarhospital Eskilstuna
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1. Study Identification

Unique Protocol Identification Number
NCT01362127
Brief Title
Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia
Acronym
NeoRes
Official Title
Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2006 (Actual)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
University Hospital, Umeå, Region Örebro County, Sahlgrenska University Hospital, Sweden, Ullevaal University Hospital, Haukeland University Hospital, Oslo University Hospital, St. Olavs Hospital, Malarhospital Eskilstuna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this randomized study is to clarify if neoadjuvant radiochemotherapy gives a higher degree of complete histological response than neoadjuvant chemotherapy before surgery in patients undergoing treatment for cancer of the esophagus or cardia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell, Adenocarcinoma of the Esophagus and Gastric Cardia
Keywords
Histologically confirmed squamos cell carcinoma or adenocarcinoma of the esophagus and gastric cardia.Suitable for surgery.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiochemotherapy
Arm Type
Active Comparator
Arm Description
Arm I: Radiochemotherapy + Surgery
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Arm II: Chemotherapy + surgery
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.
Intervention Description
Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.
Intervention Type
Radiation
Intervention Name(s)
Radiochemotherapy
Other Intervention Name(s)
Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.
Intervention Description
Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.
Primary Outcome Measure Information:
Title
Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia.
Description
Chireac tumour regression grade
Time Frame
Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy.
Secondary Outcome Measure Information:
Title
Safety of Respective Neoadjuvant Therapies.
Description
Safety profile of carrying out radical surgery after respective neoadjuvant therapy.
Time Frame
Five years follow up
Title
HRQOL and Swallowing Function
Description
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.
Time Frame
Entry study up to Five years follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically verified squamos cell carcinoma, adenocarcinoma of the esopohagus or gastric cardia (type II) Tumor located in cervical oesophagus, not requiring laryngo-esophagectomy. Patients with performance status 0-1 axxording to WHO scale and with resectable tumours, as assessed at the prerandomisation evaluation Adequate haemotological function, defined as having WBC > 3 x 10(9)/litre and platelets > 100 x 10 (9)/litre. Adequate renal function defined as having normal serum creatinine level and/or calculated glomerular filtration rate > 60 ml/min. Tumour stage: T1Ni, T2N0, T2N1, T3N0, T3N1, M1a Exclusion Criteria: Pregnancy and/or lactation. Women of childbearing ages can be included and provided that adequate contraceptive methods are used Patients with diabetes complications (e.g. rethinopathy, neuropathy) as well as patients with uncontrolled cardiac disease or myocard infarction within 12 months are considered unsuitable for chemoradiotherapy. Concomitant malignancy (< 5 years since diagnosis) that can interfere the interpretation of study results, ongoing antitumoral treatment. Patients being unable tom comply with the protocol Tumor stage T1 N0, T4 NX or TXNXM1b
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Nilsson, Professor
Organizational Affiliation
Karolinska University Hospital, Gastrocentrum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Lundell, Professor
Organizational Affiliation
Karolinska University Hospital, Gastrocentrum
Official's Role
Study Chair
Facility Information:
Facility Name
Upper Digestive Diseases. Department of surgery, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26782957
Citation
Klevebro F, Alexandersson von Dobeln G, Wang N, Johnsen G, Jacobsen AB, Friesland S, Hatlevoll I, Glenjen NI, Lind P, Tsai JA, Lundell L, Nilsson M. A randomized clinical trial of neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy for cancer of the oesophagus or gastro-oesophageal junction. Ann Oncol. 2016 Apr;27(4):660-7. doi: 10.1093/annonc/mdw010. Epub 2016 Jan 17.
Results Reference
result
PubMed Identifier
31436322
Citation
Sunde B, Klevebro F, Johar A, Johnsen G, Jacobsen AB, Glenjen NI, Friesland S, Lindblad M, Ajengui A, Lundell L, Lagergren P, Nilsson M. Health-related quality of life in a randomized trial of neoadjuvant chemotherapy or chemoradiotherapy plus surgery in patients with oesophageal cancer (NeoRes trial). Br J Surg. 2019 Oct;106(11):1452-1463. doi: 10.1002/bjs.11246. Epub 2019 Aug 22.
Results Reference
result
PubMed Identifier
30137281
Citation
von Dobeln GA, Klevebro F, Jacobsen AB, Johannessen HO, Nielsen NH, Johnsen G, Hatlevoll I, Glenjen NI, Friesland S, Lundell L, Yu J, Nilsson M. Neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy for cancer of the esophagus or gastroesophageal junction: long-term results of a randomized clinical trial. Dis Esophagus. 2019 Feb 1;32(2). doi: 10.1093/dote/doy078.
Results Reference
result
PubMed Identifier
25908010
Citation
Klevebro F, Johnsen G, Johnson E, Viste A, Myrnas T, Szabo E, Jacobsen AB, Friesland S, Tsai JA, Persson S, Lindblad M, Lundell L, Nilsson M. Morbidity and mortality after surgery for cancer of the oesophagus and gastro-oesophageal junction: A randomized clinical trial of neoadjuvant chemotherapy vs. neoadjuvant chemoradiation. Eur J Surg Oncol. 2015 Jul;41(7):920-6. doi: 10.1016/j.ejso.2015.03.226. Epub 2015 Apr 8.
Results Reference
result
PubMed Identifier
30084992
Citation
Sunde B, Johnsen G, Jacobsen AB, Glenjen NI, Friesland S, Lindblad M, Rouvelas I, Wang N, Lundell L, Lagergren P, Nilsson M. Effects of neoadjuvant chemoradiotherapy vs chemotherapy alone on the relief of dysphagia in esophageal cancer patients: secondary endpoint analysis in a randomized trial. Dis Esophagus. 2019 Feb 1;32(2). doi: 10.1093/dote/doy069.
Results Reference
result
PubMed Identifier
27254026
Citation
Lund M, Tsai JA, Nilsson M, Winter R, Lundell L, Kalman S. Effects of neoadjuvant chemo or chemoradiotherapy for oesophageal cancer on perioperative haemodynamics: A prospective cohort study within a randomised clinical trial. Eur J Anaesthesiol. 2016 Sep;33(9):653-61. doi: 10.1097/EJA.0000000000000480.
Results Reference
derived
PubMed Identifier
25582305
Citation
Lund M, Alexandersson von Dobeln G, Nilsson M, Winter R, Lundell L, Tsai JA, Kalman S. Effects on heart function of neoadjuvant chemotherapy and chemoradiotherapy in patients with cancer in the esophagus or gastroesophageal junction - a prospective cohort pilot study within a randomized clinical trial. Radiat Oncol. 2015 Jan 13;10:16. doi: 10.1186/s13014-014-0310-7.
Results Reference
derived

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Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia

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