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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01362127
First Posted: May 27, 2011
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by (Responsible Party):
Magnus Nilsson, Karolinska University Hospital
  Purpose
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.

Condition Intervention Phase
Carcinoma, Squamous Cell Adenocarcinoma of the Esophagus and Gastric Cardia Drug: Chemotherapy Radiation: Radiochemotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy

Resource links provided by NLM:


Further study details as provided by Magnus Nilsson, Karolinska University Hospital:

Primary Outcome Measures:
  • To evaluate whether radiochemotherapy gives higher complete histological response (pCR) after resection than chemotherapy alone in patients with resectable carcinoma of the esophagus and cardia. [ 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 Measures:
  • To evaluate the safety of respective neoadjuvant therapies. [ Time Frame: Three years follow up ]

    To assess the safety profile of carrying out radical surgery after respective neoadjuvant therapy.

    To study the overall and disease free survival in respective groups. To evaluate if pretreatment tumor characteristics predict the pCR and oncomplete pCR rates.



Estimated Enrollment: 180
Study Start Date: October 2006
Estimated Study Completion Date: June 2018
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiochemotherapy
Radiochemotherapy + Surgery
Radiation: Radiochemotherapy
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.
Other Name: Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.
Active Comparator: Chemotherapy
Chemotherapy + surgery
Drug: Chemotherapy
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.
Other Name: Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.
Radiation: Radiochemotherapy
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.
Other Name: Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362127


Locations
Sweden
Gastrocentrum. Department of surgery, Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
University Hospital, Umeå
Region Örebro County
Sahlgrenska University Hospital, Sweden
Ullevaal University Hospital
Haukeland University Hospital
Oslo University Hospital
St. Olavs Hospital
Malarhospital Eskilstuna
Investigators
Principal Investigator: Magnus Nilsson, AssProfessor Karolinska University Hospital, Gastrocentrum
Study Chair: Lars Lundell, Professor Karolinska University Hospital, Gastrocentrum
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Magnus Nilsson, Ass Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01362127     History of Changes
Other Study ID Numbers: EU-nr 2006-001785-16
2006-001785-16 ( EudraCT Number )
First Submitted: May 26, 2011
First Posted: May 27, 2011
Last Update Posted: February 20, 2017
Last Verified: February 2017

Keywords provided by Magnus Nilsson, Karolinska University Hospital:
Histologically confirmed squamos cell carcinoma or adenocarcinoma of the esophagus and gastric cardia.Suitable for surgery.

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Neoplasms, Squamous Cell
Oxaliplatin
Cisplatin
Carboplatin
Antineoplastic Agents