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Endometrial CancerPhase 2NCT01244789

Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer

A Phase 2 study testing carboplatin and paclitaxel and observation in people with Endometrial Cancer, run by Danish Gynecological Cancer Group at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Patients with stage 1 \& 2 endometrial cancer are treated with surgery. Despite the fact that disease is confound to uterus, unfortunately some of these patients may relapse and die of their disease. Postoperative radiotherapy cannot improve survival. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
carboplatin and paclitaxel and observation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
1 siteDenmark
Study dates
Dec 2011to 1 Jul 2028
Phase
Phase 2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Target Population
  • Only node-negative patients are eligible: Histological confirmed endometrial carcinoma with no macroscopic remaining tumour after primary surgery and lymph-node negative disease, with one of the following postoperative FIGO 2009 stage and grade:
  • Stage I grade 3 endometrioid adenocarcinoma
  • Stage II endometrioid adenocarcinoma
  • Stage I and II type 2 histology (clear cell, serous, squamous cell carcinoma, or undifferentiated carcinoma) Prior therapy
  • Patients have undergone hysterectomy (total abdominal hysterectomy, radical hysterectomy, laparoscopic or robotic hysterectomy) and bilateral salpingo-oophorectomy (BSO) and pelvic lymphadenectomy (LNE).
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  • LNE: minimum 12 pelvic nodes (6 from each side) should be removed. Para-aortic LNE is optional
  • Omentectomy strongly recommended in clear cell, serous or undifferentiated carcinoma.
  • Surgery performed within 10 weeks of randomization. If the dates for hysterectomy and lymph node dissection are different, 10 weeks are counted from the last surgery, and in that case the gap between two surgeries should not exceed 8 weeks.
  • Other inclusion criteria
  • Patients must give informed consent according to the rules and regulations of the individual participating centres
  • Patients have not received any other anticancer therapy other than surgery.
  • Adjuvant vaginal brachytherapy is permitted in both arms. In chemotherapy arm, timing of VBT should not cause delay in chemotherapy delivery.
  • Patients must have a WHO performance status of 0-2
  • Patients must have an adequate bone-marrow, renal and hepatic function (WBC ≥3.0x109/L, neutrophils ≥1.5x109/L, platelets ≥100x109/L, total S-bilirubin <2 x upper normal value, ALAT <2.5 x upper normal value, estimated GFR >50 ml/min (measured or calculated according to Cockroft-Gault or Jeliffe). Up to 5% deviation for hematological values and 10% deviation for s-bilirubin and ALAT are tolerated.
  • Life expectancy of at least 12 weeks
  • Patients must be fit to receive combination chemotherapy
  • Patient's age >18 years

Who cannot join

  • Target Disease Exceptions
  • Carcinosarcoma, Sarcomas or small cell carcinoma with neuroendocrine differentiation.
  • Prohibited Treatments and/or Therapies
  • External Beam Radiotherapy
  • Concurrent cancer therapy
  • Concurrent treatment with an anticancer investigational agent or participation in another anticancer clinical trial Other exclusion criteria
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  • Previous or concurrent malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin
  • Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed
  • Whatever reasons which interferes with an adequate follow-up

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Danish Gynecological Cancer Group (DGCG)

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: A Phase II Randomized Trial of Postoperative Chemotherapy or no Further Treatment for Patients With Node-negative Stage I-II Intermediate or High Risk Endometrial Cancer

Patients with stage 1 \& 2 endometrial cancer are treated with surgery. Despite the fact that disease is confound to uterus, unfortunately some of these patients may relapse and die of their disease. Postoperative radiotherapy cannot improve survival. Chemotherapy has shown survival benefit in more advanced stage disease (stage 3 \& 4).

This study evaluates if one can improve survival in intermediate and high risk early-stage patients by offering them postoperative chemotherapy. This is a randomized phase 3 trial where effect of postoperative chemotherapy is compared with postoperative observation alone (standard strategy).

Substudy: Translational research

Read the detailed description

Patients with medium and high risk stage I and II endometrial cancers have, despite radical surgery, a rather high risk for progression.

Adjuvant radiotherapy was the traditional therapy for many decades. Four randomized phase III studies and a meta-analysis have revealed that adjuvant radiotherapy improves local control at the cost of excessive short and long term toxicity, though has absolutely no impact on survival.

Two phase III studies have randomized between adjuvant radiotherapy versus adjuvant chemotherapy, both failed to show any difference in survival between radiotherapy and chemotherapy, though both studies are criticized for inferior chemotherapy regimens or inclusion of good prognosis patients. The GOG-122 study on more advanced cases (stage 3 \& 4) randomized between combination chemotherapy versus whole abdominal irradiation and found significant improvement in survival in the chemotherapy arm.

NSGO-EC-9501 and MaNGO studies have indicated that adjuvant chemotherapy added to adjuvant radiotherapy may improve survival compared to adjuvant radiotherapy alone in early stage medium and high risk patients. One may conclude that impact on survival comes only from chemotherapy. Many investigators have therefore adapted adjuvant chemotherapy as standard treatment in various countries including Denmark. However, such conclusion has low level of evidence, as there are no randomized phase III studies comparing postoperative observation alone versus adjuvant chemotherapy.

It is of utmost importance to demonstrate efficacy of adjuvant combination chemotherapy in a randomized phase III trial comparing to no further treatment in the medium and high risk node negative stage 1 \& 2 patients.

Combination chemotherapy regimen of paclitaxel-carboplatin is proposed in this study, as this combination is effective and well tolerated.

The eligible patients for such a study are a fraction of patients with endometrial cancer therefore this study will be performed within the ENGOT collaboration.

Being tested
carboplatin and paclitaxel, observation
Keywords
endometrial cancer, chemotherapy, carboplatin, paclitaxel, Stage 1 & 2, node-negative, intermediate risk, high risk
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • carboplatin and paclitaxelDrug

    6 courses of iv 3-weekly chemotherapy Carboplatin AUC5 Paclitaxel 175mg/m2

  • observationOther

    active observation

Study groups in NCT01244789
Study groupRoleWhat they receive
ObservationActive comparatorpostoperative observation only
Receives: Other: observation
Combination chemotherapyExperimentalpostoperative 6 courses of 3 weekly iv carboplatin-paclitaxel combination chemotherapy
Receives: Drug: carboplatin and paclitaxel

What is being measured

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

  1. Overall survival

    To detect an overall absolute difference in five-year survival of 10%, from 72% to 82%, at the 2.5% level with 80% power, 135 deaths corresponding to 644 patients are needed. Assuming a dropout rate of 5%, 678 patients have to be accrued, leaving 644 patients for the overall analysis.

    Measured: through study completion, an average of 1 year

Secondary outcomes (9)

  1. Overall Survival in endometrioid subgroup

    In the endometrioid subgroup an absolute difference in five-year survival of 12%, from 74% to 86% is expected. Assuming this, 79 deaths corresponding to 438 patients are needed to yield 80% power at the 2.5% level. Assuming a dropout rate of 5%, 678 patients have to be accrued, leaving 644 patients for the overall analysis and 75% of these, or 483 patients, for the analysis in the endometrioid subgroup.

    Measured: through study completion, an average of 1 year

  2. Disease Specific Survival

    Exploratory endpoint

    Measured: through study completion, an average of 1 year

  3. Progression-Free Survival

    Exploratory endpoint

    Measured: through study completion, an average of 1 year

  4. Toxicity - Acute toxicity (0-6 months from randomization). Late toxicity is registered during whole study period.

    Acute toxicity (0-6 months from randomization). Late toxicity is registered during whole study period. Exploratory endpoint

    Measured: through study duration, 13 years

  5. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN30)

    European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - (EORTC QLQ-C30)

    Measured: From enrollment to the end of treatment at 60 months

  6. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24)

    European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire- Endometrial Cancer Module, 24

    Measured: From enrollment to the end of treatment at 60 months

  7. Rate of isolated pelvic relapse

    Exploratory endpoint

    Measured: through study completion, an average of 17 years

  8. Rate of isolated distant relapse

    Exploratory endpoint

    Measured: through study completion, an average of 17 years

  9. Rate of mixed (local & distant) relapses

    Exploratory endpoint

    Measured: through study completion, an average of 17 years

Timeline

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

  1. First posted19 Nov 2010 (estimated)
  2. Study startDec 2011
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Jul 2028 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01244789
Sponsor's protocol ID
ENGOT-EN2-DGCG
Other IDs
2010-023081-52
Status last verified
Apr 2026
First submitted
18 Nov 2010
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin and paclitaxel and observation in people with Endometrial Cancer, run by Danish Gynecological Cancer Group at 1 site in Denmark.

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 18 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: through study completion, an average of 1 year). 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 NCT01244789.

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 13 Apr 2026.

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