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New combo therapy for cervical cancer shows promise in early trial

NCT ID NCT00957411

Disease control Sponsor: Institut Curie 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested whether adding the targeted drug cetuximab to standard chemoradiation (cisplatin plus radiation) improves outcomes for people with locally advanced cervical cancer (stages IB2 to IIIB). 76 participants were randomly assigned to receive either chemoradiation alone or chemoradiation plus cetuximab. The study measured recurrence-free survival at 2 years and treatment side effects.

What this could mean

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

Active substance
cetuximab (a targeted antibody) and cisplatin (chemotherapy)
What this could lead to
If successful, this could show that adding cetuximab to standard chemoradiation improves recurrence-free survival for locally advanced cervical cancer.
What could go wrong
This is a small, early-phase trial (76 people) and results may not apply broadly. Adding cetuximab could increase side effects without clear benefit.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

76 people

The number who actually took part.

Start date

Mar 2009

Finished

Oct 2014

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

18 to 120 years

Sex

Female participants only

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.

DISEASE CHARACTERISTICS: * Diagnosis of cervical cancer * Squamous cell carcinoma or adenocarcinoma * Stage IB2-IIIB disease * Not immediately operable * Origin of the tumor and presence of measurable target lesion according to RECIST criteria confirmed by T2-weighted MRI * Data imaging scan and PET scan (optional) confirmed absence of lumbo-aortic adenopathy * No other associated pathology that would preclude study treatment PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Hemoglobin \> 10 g/dL * ANC \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Alkaline phosphatase \< 2 times normal * Total bilirubin \< 1.5 times normal * Creatinine \< 130 μmol/L * Creatinine clearance ≥ 60 mL/min * Normal vital functions * Not pregnant * Fertile patients must use effective contraception * Able to provide the imaging exams on CD ROM (DICOM 3.0 or higher) for centralized review * No history of another cancer that recurred within the past 5 years except for basal cell carcinoma of the skin or carcinoma in situ of the cervix * No absolute contraindication to MRI (i.e., claustrophobia, pacemaker, or cochlear implant) * No geographical, social, or psychological situations that preclude study follow up * Not deprived of liberty or under guardianship * Receiving benefits from a social security system PRIOR CONCURRENT THERAPY: * No prior treatment (i.e., chemotherapy, radiotherapy, immunotherapy, hormonal therapy, or, especially, therapy with an investigational agent) for this cancer * No concurrent participation in a clinical trial with an experimental agent

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Conditions

The condition(s) this trial relates to.

cervical cancer Uterine Cervical Neoplasms

As listed by the trial registrant

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

Cervical cancer

Contacts and locations

Locations

  • Institut Curie Hopital

    Paris, 75248, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.