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Can a more intense radiation schedule outperform Chemo-Radiation for head and neck cancer?

NCT ID NCT00162708

Disease control Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial tests two aggressive radiation therapy schedules for people with advanced head and neck cancer that cannot be removed with surgery. One approach uses a very intense radiation schedule combined with chemotherapy, while the other uses a very accelerated radiation schedule alone. The goal is to see which strategy better prevents the cancer from growing or spreading, and to compare side effects and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radiotherapy (very accelerated or very intense) with or without chemotherapy (cisplatin and 5-fluorouracil)
What this could lead to
If successful, this could identify a more effective radiation schedule, with or without chemo, to improve control of advanced head and neck cancers.
What could go wrong
This is a phase 2/3 trial, so results are not guaranteed. The intense treatments may increase side effects, and the study is limited to a specific group of patients with inoperable tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

120 people

Start date

Jul 1996

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * palpable N2b-c or N3 (UICC 1997) squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx or larynx) * primary tumor and / or nodal extension strictly inoperable due to the extension of the disease * performance status of 0 to 2 (WHO scoring system) * renal/liver/cardiac functions and blood counts compatible with the use of CDDP and 5-FU * signed inform consent Exclusion Criteria: * distant metastasis * previous history of cancer * previous radiotherapy or chemotherapy

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma hypopharynx cancer laryngeal neoplasm larynx cancer lip and oral cavity carcinoma Mouth Neoplasms oropharynx cancer Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypopharynx cancer Larynx cancer Oral cancer Oropharynx cancer

Contacts and locations

Locations

  • Centre Alexis Vautrin

    Nancy, France

  • Centre Jean Perrin

    Clermont-Ferrand, France

  • Institut Gustave Roussy

    Villejuif, 94800, France

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