TriangleNCT00331760 · STUDY IN CONTEXT
Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is \<= 80%. The alternative hypothesis is that the true probability is \>= 95%. For \[vagina / pelvic lymph nodes\]: UD is defined as: The 90% isodose surface covers \< 95% of \[internal target volume (ITV)/ planned target volume (PTV)\] 50.4 or \> 5% of the \[ITV/PTV\] 50.4 receives over 115%.
Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event.
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Late is defined as more than 90 days after the start of radiation therapy.
Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites.
Local-regional failure time is defined as time from registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only), death without local-regional failure (competing risk), or last known follow-up (censored). Local-regional failure rates are estimated by the cumulative incidence method.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- trial label
- Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0000
- source section id
- NCT00331760-om-0000
- source outcome index
- 0
- endpoint
- Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
- endpoint definition
- Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is \<= 80%. The alternative hypothesis is that the true probability is \>= 95%. For \[vagina / pelvic lymph nodes\]: UD is defined as: The 90% isodose surface covers \< 95% of \[internal target volume (ITV)/ planned target volume (PTV)\] 50.4 or \> 5% of the \[ITV/PTV\] 50.4 receives over 115%.
- time origin
- IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0001
- source section id
- NCT00331760-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Patients With Grade 2+ Bowel Adverse Events
- endpoint definition
- Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event.
- time origin
- From the start of treatment to 90 days.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who started study treatment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0002
- source section id
- NCT00331760-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events
- endpoint definition
- Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
- time origin
- From start of treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who started study treatment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0003
- source section id
- NCT00331760-om-0003
- source outcome index
- 3
- endpoint
- Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events
- endpoint definition
- Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Late is defined as more than 90 days after the start of radiation therapy.
- time origin
- From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who started study treatment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0004
- source section id
- NCT00331760-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant
- endpoint definition
- Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites.
- time origin
- From start to end of chemotherapy, approximately five weeks from registration.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients in the chemotherapy group (cervical cancer patients) who started study treatment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0005
- source section id
- NCT00331760-om-0005
- source outcome index
- 5
- endpoint
- Rate of Local-regional Failure at Five Years
- endpoint definition
- Local-regional failure time is defined as time from registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only), death without local-regional failure (competing risk), or last known follow-up (censored). Local-regional failure rates are estimated by the cumulative incidence method.
- time origin
- From registration to five years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who started study treatment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Endometrial Cancer: IMRT
- regimen
- Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
- analyzed count
- 43
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00331760-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
- regimen
- Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00331760-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Endometrial Cancer: IMRT
- regimen
- Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
- analyzed count
- 43
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00331760-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
- regimen
- Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00331760-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Endometrial Cancer: IMRT
- regimen
- Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
- analyzed count
- 43
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00331760-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
- regimen
- Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00331760-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Endometrial Cancer: IMRT
- regimen
- Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
- analyzed count
- 43
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00331760-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
- regimen
- Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00331760-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
- regimen
- Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00331760-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Endometrial Cancer: IMRT
- regimen
- Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
- analyzed count
- 43
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00331760-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
- regimen
- Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00331760-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- harm key
- EG000
- source section id
- NCT00331760-ae
- event group key
- EG000
- event group label
- Endometrial Cancer: IMRT
- serious affected
- 2
- serious at risk
- 43
- other affected
- 42
- other at risk
- 43
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00331760
- harm key
- EG001
- source section id
- NCT00331760-ae
- event group key
- EG001
- event group label
- Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
- serious affected
- 3
- serious at risk
- 40
- other affected
- 39
- other at risk
- 40
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice