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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University Hospital, Umeå
University Hospital Orebro
Sahlgrenska University Hospital, Sweden
Ullevaal University Hospital
Haukeland University Hospital
Oslo University Hospital
St. Olavs Hospital
Malarhospital Eskilstuna
Information provided by (Responsible Party):
Lars Lundell, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01362127
First received: May 26, 2011
Last updated: March 11, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the safety of respective neoadjuvant therapies. [ Time Frame: Three years follow up ] [ Designated as safety issue: Yes ]

    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: March 2018
Estimated Primary Completion Date: March 2018 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362127

Locations
Sweden
Gastrocentrum. Department of surgery, Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
University Hospital, Umeå
University Hospital Orebro
Sahlgrenska University Hospital, Sweden
Ullevaal University Hospital
Haukeland University Hospital
Oslo University Hospital
St. Olavs Hospital
Malarhospital Eskilstuna
Investigators
Principal Investigator: Lars Lundell, Professor Karolinska University Hospital, Gastrocentrum
  More Information

Additional Information:
No publications provided

Responsible Party: Lars Lundell, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01362127     History of Changes
Other Study ID Numbers: EU-nr 2006-001785-16, 2006-001785-16
Study First Received: May 26, 2011
Last Updated: March 11, 2014
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Oxaliplatin
Cisplatin
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014