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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year after randomisation

Awards & highlights

NEEDS 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.Check my eligibility

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.See study design

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.

NEEDS Trial 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.

NEEDS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Eating restrictions

Global Health-related quality of life (HRQOL)

Overall survival

Secondary outcome measures

Event-free survival

Gender stratified analyses of all endpoints

Health economy

+9 more

NEEDS 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: 1.8 Gy fractions five days per week in 28 fractions to a total dose of 50.4 Gy. 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Swedish Research CouncilOTHER_GOV

143 Previous Clinical Trials

4,162,519 Total Patients Enrolled

Karolinska University HospitalLead Sponsor

477 Previous Clinical Trials

1,304,178 Total Patients Enrolled

University of LeipzigOTHER

206 Previous Clinical Trials

1,279,380 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with administering Experimental arm (B)?

"We have rated the safety of Experimental arm (B) at 3 due to multiple rounds of data showing its efficacy and corroborated evidence supporting its security."

Answered by AI

Does this research study accept elderly participants?

"The eligibility requirements for this trial encompass people between 18 and 80 years of age. For individuals younger than 18, there are 202 trials available while those aged over 65 have access to 4181 studies."

Answered by AI

How many medical facilities are actively engaged in running this experiment?

"This experiment is available at 12 different medical centres, including Norrlands universitetssjukhus in Umeå, Skåne University Hospital in Lund and St Olavs Hospital in Trondheim."

Answered by AI

Is there still capacity for participation in this research?

"Affirmative. Clinicaltrials.gov affirms the active recruitment of participants for this medical experiment, which was first posted on November 27th 2020 and edited as recently as October 3rd 2023. The trial is hoping to enrol 1020 patients from 12 different clinical sites."

Answered by AI

What type of ailment does Experimental arm (B) typically target?

"Arm (B) of the experiment is widely used to address malignant neoplasms, as well as rectal cancer, advanced gastric cancer and pre-transplant conditioning for allogeneic stem cell therapy."

Answered by AI

What other empirical research has been executed involving Experimental arm (B)?

"Currently, 1622 active clinical trials are examining the efficacy of Experimental arm (B), with 523 studies in Phase 3. Although Guangzhou, Guangdong is home to the majority of tests for Experimental arm (B), there are 96753 global sites running related experiments."

Answered by AI

How many participants will be accepted into this experiment?

"Affirmative, the clinicaltrials.gov page implies that recruitment for this research study is ongoing. It was rolled out on November 27th 2020 and most recently updated October 3rd 2023 with plans to enroll 1020 participants at 12 sites across the nation."

Answered by AI

Does my medical background make me a suitable candidate for this experiment?

"This medical trial is looking for 1020 participants aged between 18 and 80 with esophageal cancer. Furthermore, in order to be eligible these patients must present specific histopathological characteristics, have a performance score of 0-1 on the ECOG scale, demonstrate adequate organ function, not be pregnant or breastfeeding (if applicable), commit to using birth control during treatment duration and post-treatment follow up periods, provide written informed consent according to ICH/GCP/GDPR regulations, and show no psychological or familial factors that may impede compliance with study protocol."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer

Magnus Nilsson 2020. "Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04460352.

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