Feasibility study of adjuvant chemotherapy in patients with oesophageal cancer who received neoadjuvant chemotherapy and underwent curative surgery

Phase 1

• Conditions: early stage esophageal cancer; Cancer - Oesophageal (gullet)

• Registration Number: ACTRN12616000554460
• Lead Sponsor: South Adelaide Local Health Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

The target population is patients with locally advanced adenocarcinoma of oesophagus and OGJ who underwent neoadjuvant CRT and curative intent surgical resection.
Key eligibility criteria include:
* Histologically or cytologically proven adenocarcinoma of oesophagus/OGJ
* Pre-treatment clinical stage T1N1M0 or T2-3N0-3M0
* Age >18 years , No maximum age specified. ECOG performance status of 0-1
* Have had neoadjuvant CRT and curative intent surgery for oesophageal/OGJ adenocarcinoma
* Neoadjuvant CRT employing CF or carboplatin-paclitaxel chemotherapy is allowed
* No evidence of metastatic disease 6-8 weeks post-surgery
* Adequate recovery from surgical resection (6-8 weeks) and able to commence treatment within 8-10 weeks

Exclusion Criteria

1. Evidence of metastatic disease from oesophageal or OGJ adenocarcinoma
2. Previous chemotherapy, radiotherapy or other investigational drug treatment for oesophageal or OGJ adenocarcinoma other than the neoadjuvant CRT
3. History of other malignancies other than non-melanomatous skin cancer or in-situ carcinoma of cervix
4. Severe or uncontrolled cardiovascular disease including acute coronary syndrome within the last 12 months and cardiac failure New York Heart Association (NYHA) III and IV
5. Concurrent illness that may jeopardise the ability of the patient to undergo procedures outlined in this protocol with reasonable safety
6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
7. Known hypersensitivity to cisplatin or 5 fluorouracil (5FU), or dihydropyrimidine dehydrogenease (DPD) deficiency
8. Medical or psychiatric conditions that compromise the patient’s ability to give informed consent
9. Pregnancy, lactation or inadequate contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified