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Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Carcinoma, Squamous Cell, Adenocarcinoma of the Esophagus and Gastric Cardia

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Trial Information

Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy.

Safety Issue:

Yes

Principal Investigator

Lars Lundell, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karolinska University Hospital, Gastrocentrum

Authority:

Sweden: Medical Products Agency

Study ID:

EU-nr 2006-001785-16

NCT ID:

NCT01362127

Start Date:

October 2006

Completion Date:

March 2018

Related Keywords:

  • Carcinoma, Squamous Cell
  • Adenocarcinoma of the Esophagus and Gastric Cardia
  • Histologically confirmed squamos cell carcinoma or adenocarcinoma of the esophagus and gastric cardia.Suitable for surgery.
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Neoplasms

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