Adaptive Radiotherapy in Patients With Gynecological Tumors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Essen

About this trial

Prospective randomized evaluation of adaptive radiotherapy in the definitive radiotherapy of locally advanced gynecologic carcinoma (e.g. cervical carcinoma, endometrial carcinoma, vaginal carcinoma), in the postoperative situation or first series of external beam radiotherapy and in patients in whom radical surgery or HDR brachytherapy as dose boost is not an option.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Adaptive Radiotherapy

    Radiation

    Adaptive Radiotherapy, online onboard adaptation of dose distribution with a specialist radiation oncologist and a medical physicist

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Interventional ArmExperimental treatment 1 intervention
Group B: Standard conventional Treatment Arm, IGRTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rectal Toxicity

Rectum, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, \[score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)\]

Time frame
2 weeks to 5 years
2

Bladder Toxicity

Bladder, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, \[score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)\]

Time frame
2 weeks to 5 years
3

Skin Toxicity

Skin, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, \[score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)\]

Time frame
2 weeks to 5 years
4

Lymph-Edema grade

Lymph-Edema, EORTC CTC-AE ( (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-3, \[score 1: nearly no toxicity, asymptomatic changes - score 3: worst outcome, severe symptoms; limiting self care ADL\]

Time frame
2 weeks to 5 years

Secondary outcomes

1

Overall Survival

Overall Survival

Time frame
5 years
2

Progression Free Survival

Progression Free Survival

Time frame
5 years

Other outcomes

Sponsors and contacts

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