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Platinum-based Chemotherapy

Chemoradiotherapy + Surgery for Esophageal Cancer (NEEDS Trial)

Phase 3

Recruiting

Research Sponsored by Karolinska University Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histopathologically confirmed SCC of the esophagus in locally advanced stages cT1 N+ or cT2-4a any N, M0, according to current (8th) version of the AJCC TNM classification

Performance status ECOG 0-1

Must not have

Subjects with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry

M1 according to current (8th) version of of the AJCC TNM classification

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year after randomisation

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to compare treatments to help patients with cancer of the esophagus and provide generalizable guidance to improve future clinical practice.

Who is the study for?

This trial is for adults with a specific type of esophageal cancer (SCC) that hasn't spread beyond the local area. They must be in good physical condition, have organs functioning well, and women must not be pregnant or breastfeeding. Participants should use effective birth control and commit to following the study's procedures.

What is being tested?

The NEEDS trial compares two approaches: one group receives chemotherapy plus radiotherapy before surgery, while another gets the same treatments but only has surgery if necessary later on. The focus is on survival rates, quality of life, and eating ability after treatment.

What are the potential side effects?

Chemotherapy drugs like Carboplatin and Cisplatin can cause nausea, fatigue, hair loss, nerve damage; Oxaliplatin may lead to cold sensitivity or jaw tightness; Radiotherapy might result in skin irritation or difficulty swallowing; Surgery risks include infection and breathing problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My esophagus cancer is confirmed and in an advanced stage but hasn't spread to distant organs.

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I am fully active or can carry out light work.

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My cancer can be surgically removed as per my medical team's advice.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been cancer-free for at least 5 years from a previous cancer.

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My cancer has spread to distant parts of my body.

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My throat cancer cannot be removed without taking out my voice box.

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I have had radiotherapy or chemoradiotherapy that might overlap with new treatment areas.

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My cancer is classified as cT4b, meaning it has grown into nearby structures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year after randomisation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year after randomisation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year after randomisation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Eating restrictions

Global Health-related quality of life (HRQOL)

Overall survival

Secondary study objectives

Event-free survival

Health economy

Health related quality of life of Cancer patients

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental arm (B)Experimental Treatment5 Interventions

Definitive chemoradiotherapy followed by surveillance, and esophagectomy only in case of residual or recurrent locoregional cancer. Radiotherapy: Two alternative schemes: 1. 1.8 Gy fractions five days per week in 28 fractions to a total dose of 50.4 Gy. 2. 2.0 Gy fractions five days per week in 25 fractions to a total dose of 50 Gy. Chemotherapy: Three alternative regimens: 1. Platin-Taxane Regimen: Carboplatin AUC 2 + Paclitaxel 50mg/m2 on day 1 weekly during the full course of radiotherapy. 2a. Platinum-Fluoropyrimidine Regimen: Cisplatin 75mg/m2 weeks 1 and 5 + 5-fluorouracil 1000 mg/m2/day by continuous infusion weeks 1 and 5. 2b. FOLFOX: Oxaliplatin 85 mg/m2, calcium folinate 200 mg/m2 and 5-fluorouracil 400 mg/m2 weeks 1, 3 and 5 + 5-fluorouracil 800 mg/m2 by continuous infusion weeks 1, 3 and 5.

Group II: Control arm (A)Active Control3 Interventions

Neoadjuvant chemoradiotherapy followed by esophagectomy. Radiotherapy: 1.8 Gy fractions 5 days per week in 23 fractions to a total dose of 41.4 Gy. Chemotherapy: Carboplatin AUC 2 + Paclitaxel 50mg/m2 weekly x 5 (day 1, 8, 15, 22, 29), starting on the first day of radiotherapy. Esophagectomy: Within 8 weeks of termination of chemoradiotherapy,

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Esophagectomy

2016

Completed Phase 3

~4130

0 / 8Eligibility criteria met