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Esophageal Squamous Cell CarcinomaPhase 3NEEDSNCT04460352

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

A Phase 3 study testing Neoadjuvant radiotherapy (arm A), Carboplatin, paclitaxel and Esophagectomy in people with Esophageal Squamous Cell Carcinoma, run by Karolinska University Hospital at 12 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

NEEDS is a pragmatic open-label, randomised, controlled, phase III, multicenter trial with non-inferiority design with regard to the first co-primary endpoint overall survival and superiority for the experimental intervention definitive chemoradiotherapy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Neoadjuvant radiotherapy (arm A), Carboplatin, paclitaxel and Esophagectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,020 participants
Where
12 sitesin 5 countries
Study dates
27 Nov 2020to 31 Dec 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathologically confirmed SCC of the esophagus in locally advanced stages cT1 N+ or cT2-4a any N, M0, according to current (8th) version of of the AJCC TNM classification.
  • Technically resectable disease according to the local multidisciplinary team conference (MDT)/tumor board.
  • Performance status ECOG 0-1.
  • Adequate organ function.
  • Women of childbearing potential (WOCBP*) must have a negative serum or urine pregnancy test.
  • Patients of childbearing/reproductive potential should use highly effective method of birth control measures during the study treatment period and for at least five months after the last study treatment.
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  • Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment.
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Before patient registration/randomization, written informed consent must be given according to ICH/GCP/GDPR and national/local regulations.

Who cannot join

  • M1 according to current (8th) version of of the AJCC TNM classification.
  • cT4b according to current (8th) version of of the AJCC TNM classification.
  • Primary tumor not resectable without laryngectomy.
  • Impaired renal, hepatic, cardiac, pulmonary or endocrine status that compromises the eligibility of the patient for multimodality treatment with chemoradiotherapy followed by esophagectomy.
  • Subjects not considered likely to tolerate multimodality treatment with chemoradiotherapy followed by esophagectomy.
  • Subjects with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry.
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  • Prior or concomitant treatment with radiotherapy or chemoradiotherapy with potential overlap of radiotherapy fields.
  • Known uncontrollable hypersensitivity to the components of the chemotherapeutic agents used in the trial regimens.
  • Inability to fully understand and digest study patient information or to comply with study instructions due to language difficulty or cognitive failure such as dementia or severe psychiatric disorder.
  • (Criteria slightly shortened)

Trial locations and contacts

12 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Magnus Nilsson, MD, PhD contact

+46-707-375186

magnus.nilsson@ki.se

Mats Hellström contact

mats.hellstrom@regionstockholm.se

12 sites in 5 countries

Sweden6 sites, 6 recruiting

  • Linköpings universitetssjukhus

    Linköping

    David Edholm, MD, david.edholm@regionostergotland.se

    Anna Lindhoff Larsson, RN, anna.lindhoff.larsson@regionostergotland.se

    Recruiting

  • Skånes universitetssjukhus

    Lund

    Monika Meszaros, RN, monika.meszaros@skane.se

    Marit Bakos, RN, marit.bakos@skane.se

    Recruiting

  • Örebro universitetssjukhus

    Örebro

    Linnea Sundström, RN, linnea.sundstrom@regionorebrolan.se

    Eva Szabo, MD, PhD

    Recruiting

  • Karolinska University Hospital

    Stockholm

    Berit Sunde, RN, PhD, berit.sunde@ki.se

    Maria Lampi, RN, maria.lampi@regionstockholm.se

    Recruiting

  • Norrlands universitetssjukhus

    Umeå

    Birgitta Orrvik Olsson, RN, birgitta.orrvikolsson@regionvasterbotten.se

    Agneta Karhu, RN, agneta.karhu@regionvasterbotten.se

    Recruiting

  • Akademiska sjukhuset

    Uppsala

    Lena Ekfjord, RN, lena.ekfjord@akademiska.se

    Jakob Hedberg, MD, PhD

    Recruiting

Other trials in Sweden

Norway3 sites, 3 recruiting

  • Oslo universitetssykehus

    Oslo

    Janne Christoffersen, RN, jannec@ous-hf.no

    Ghazwan Al-Haidari, MD, PhD

    Recruiting

  • Universitetssykehuset Nord-Norge

    Tromsø

    Eirik Kjus Aahlin, MD, PhD, eirik.kjus.aahlin@unn.no

    Kristin Woll, RN, kristin.woll@unn.no

    Recruiting

  • St Olavs Hospital

    Trondheim

    Marte Romundstad, RN, marte.romunstad@stolav.no

    Lars Cato Rekstad, MD, PhD

    Recruiting

Other trials in Norway

Canada1 site, 1 recruiting

  • McGill University Health Centre

    Montreal, Quebec

    Mehrnoush Dehgani, PhD, mehrnoush.dehghani@muhc.mcgill.ca

    Lorenzo Ferri, MD, PhD

    Recruiting

Other trials in Canada

Ireland1 site, 1 recruiting

  • Cancer Clinical Trials Unit (CCTU) at St. James's Hospital

    Dublin, Dublin, D08 NHY1

    Ingrid Kiernan, +353 1 4103754, cancerclinicaltrials@stjames.ie

    John Reynolds, Prof

    Recruiting

Other trials in Ireland

Taiwan1 site, 1 recruiting

  • Chang Gung Memorial Hospital

    Linkou District

    Yinkai Chao, MD, chaoyk@gmail.com

    Tzuyi Yang, larryboy0945@cgmh.org.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: NEoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed (NEEDS Trial)

NEEDS is a pragmatic open-label, randomised, controlled, phase III, multicenter trial with non-inferiority design with regard to the first co-primary endpoint overall survival and superiority for the experimental intervention definitive chemoradiotherapy. A second co-primary endpoint is global health related quality of life (HRQOL) one year after randomisation. A third co-primary endpoint is eating restictions one year after randomisation.

The aim is to compare outcomes after neoadjuvant chemoradiotherapy with subsequent esophagectomy to definitive chemoradiotherapy with surveillance and salvage esophagectomy as needed in patients with resectable locally advanced squamous cell carcinoma (SCC) of the esophagus, with the aim to provide generalisable guidance for future clinical practice.

Being tested
Neoadjuvant radiotherapy (arm A), Carboplatin, paclitaxel, Esophagectomy, Neoadjuvant radiotherapy (arm B), Cisplatin, paclitaxel
Keywords
Neoadjuvant chemoradiotherapy, Definitive chemoradiotherapy with salvage surgery as needed
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant radiotherapy (arm A)Radiation

    1.8 Gy fractions 5 days per week in 23 fractions to a total dose of 41.4 Gy.

  • Carboplatin, paclitaxelDrug

    Also called Neoadjuvant chemotherapy

    Carboplatin AUC 2 + Paclitaxel 50mg/m2 weekly x 5 (day 1, 8, 15, 22, 29), starting same day as radiotherapy

  • EsophagectomyProcedure or surgery

    Esophagectomy performed within 8 weeks after termination of chemoradiotherapy

  • Neoadjuvant radiotherapy (arm B)Radiation

    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.

  • Carboplatin, paclitaxelDrug

    Also called Neoadjuvant Platin-Taxane Regimen (alternative 1)

    Carboplatin AUC 2 + Paclitaxel 50mg/m2 on day 1 weekly during the full course of radiotherapy (5 weeks or 6 weeks, depending on the radiotherapy regimen used).

  • Cisplatin, paclitaxelDrug

    Also called Platinum-Fluoropyrimidine Regimens (alternative 2a)

    Cisplatin 75mg/m2 on the first day of weeks 1 and 5 + 5-fluorouracil 1000 mg/m2/day by continuous infusion on the first four days of weeks 1 and 5.

  • Oxaliplatin, calcium folinate, 5-fluorouracilDrug

    Also called Platinum-Fluoropyrimidine Regimens (alternative 2b)

    FOLFOX: Oxaliplatin 85 mg/m2, calcium folinate 200 mg/m2 and 5-fluorouracil 400 mg/m2 on the first days of weeks 1, 3 and 5 + 5-fluorouracil 800 mg/m2 by continuous infusion on the first two days of weeks 1, 3 and 5.

  • EsophagectomyProcedure or surgery

    Esophagectomy only in case of residual or recurrent locoregional cancer.

Study groups in NCT04460352
Study groupRoleWhat they receive
Control arm (A)Active comparatorNeoadjuvant 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,
Receives: Radiation: Neoadjuvant radiotherapy (arm A); Drug: Carboplatin, paclitaxel; Procedure: Esophagectomy
Experimental arm (B)ExperimentalDefinitive 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.
Receives: Radiation: Neoadjuvant radiotherapy (arm B); Drug: Carboplatin, paclitaxel; Drug: Cisplatin, paclitaxel; Drug: Oxaliplatin, calcium folinate, 5-fluorouracil; Procedure: Esophagectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    When 398 events have occurred

    Measured: 3 years after randomisation

  2. Global Health-related quality of life (HRQOL)

    European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30, version 3.0 (EORTC QLQ-C30). The two items assessing global health and overall quality of life are responded to in seven categories ranging from 1 (very poor) to 7 (excellent).

    Measured: 1 year after randomisation

  3. Eating restrictions

    EORTC QLQ-OG25 instrument. This instrument consists of 25 items covering upper gastric symptoms or problems in four categories ranging from 1 (Not at all) to 4 (Very much).

    Measured: 1 year after randomisation

Secondary outcomes (12)

  1. Health related quality of life of Cancer patients

    EORTC HRQOL Questionnaire QLQ-C30 version 3.0, 28 items ranging from 1 (no problems at all) to 4 (very much) and two items assessing global health and overall quality of life are responded to in seven categories ranging from 1 (very poor) to 7 (excellent).

    Measured: At randomisation but before start of treatment and thereafter 6, 12, 24, 36 and 60 months after randomisation

  2. Health related quality of life, oesophageal specific.

    EORTC HRQOL gastresophageal-specific questionnaire EORTC QLQ-OG25. 25 items assessing symptoms or problems are responded to in four categories ranging from 1 (no problems) to 4 (very much).

    Measured: At randomisation but before start of treatment and thereafter 6, 12, 24, 36 and 60 months after randomisation

  3. Health related quality of life, general health

    The EuroQoL Group's EQ-5D-5L questionnaire consisting of five dimensions ranging from No problems to Extreme problems or Unable to care.

    Measured: At randomisation but before start of treatment and thereafter 6, 12, 24, 36 and 60 months after randomisation

  4. Event-free survival

    Time to relapse, initiation of any anti-tumor therapy beyond the study treatments (salvage surgery is considered a study treatment in the dCRT arm), or death, whichever comes first.

    Measured: 5 years after randomisation

  5. Loco-regional and distant relapse rates

    Including the relation of relapse location to the radiation field

    Measured: 5 years after randomisation

  6. Histopathological response according to Mandard in operated patients

    ypTNM including total and metastatic lymph node count, tumor free resection margins, R0

    Measured: 5 years after randomisation

  7. Health economy

    Assessed including patient-level medical resource use and societal costs due to sick-leave and other non-medical costs. Quality-adjusted life years (QALYs) will be calculated using EQ-5D

    Measured: At baseline and 6, 12, 24, 36 and 60 months after randomisation

  8. Surgical complications

    According to the Esophagectomy Complications Consensus Group (ECCG) and classified according to Clavien-Dindo

    Measured: After surgery in operated patients, up to 5 years after randomisation

  9. Treatment-related adverse events and toxicity

    NCI-CTCAE Criteria version 5.0

    Measured: Up to 5 years after randomisation

  10. Nutritional outcomes - weight

    Weight development. Weight (in kg) will be measured at all visits.

    Measured: Up to 5 years after randomisation

  11. Nutritional outcomes - dysphagia

    Dysphagia will be evaluated at all visits according to the CTC adverse event scale, grading from 0 (no problems) to 4 (worst problems).

    Measured: Up to 5 years after randomisation

  12. Gender stratified analyses of all endpoints

    Measured: Up to 5 years after randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start27 Nov 2020
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
NEEDS is a pragmatic open-label, randomised, controlled, phase III, multicenter trial with non-inferiority design with regard to the three co-primary endpoints i) Overall survival and superiority for the experimental intervention definitive chemoradiotherapy; ii) Global health related quality of life (HRQOL) one year after randomisation; iii) Eating restictions one year after randomisation.
Masking
None (open label)
Enrolment
1,020 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04460352
Sponsor's protocol ID
NEEDS
Acronym
NEEDS
Status last verified
Mar 2025
First submitted
25 Jun 2020
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nilsson M, Olafsdottir H, Alexandersson von Dobeln G, Villegas F, Gagliardi G, Hellstrom M, Wang QL, Johansson H, Gebski V, Hedberg J, Klevebro F, Markar S, Smyth E, Lagergren P, Al-Haidari G, Rekstad LC, Aahlin EK, Wallner B, Edholm D, Johansson J, Szabo E, Reynolds JV, Pramesh CS, Mummudi N, Joshi A, Ferri L, Wong RK, O'Callaghan C, Lukovic J, Chan KK, Leong T, Barbour A, Smithers M, Li Y, Kang X, Kong FM, Chao YK, Crosby T, Bruns C, van Laarhoven H, van Berge Henegouwen M, van Hillegersberg R, Rosati R, Piessen G, de Manzoni G, Lordick F. Neoadjuvant Chemoradiotherapy and Surgery for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed: The Study Protocol for the Randomized Controlled NEEDS Trial. Front Oncol. 2022 Jul 13;12:917961. doi: 10.3389/fonc.2022.917961. eCollection 2022.

    PubMed 35912196

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neoadjuvant radiotherapy (arm A), Carboplatin, paclitaxel and Esophagectomy in people with Esophageal Squamous Cell Carcinoma, run by Karolinska University Hospital at 12 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Sweden, Norway, Canada, Ireland, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Magnus Nilsson, MD, PhD (+46-707-375186, magnus.nilsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 3 years after randomisation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04460352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.

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